Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-02-21 @ 3:25 AM
Study NCT ID:
NCT01700205
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2012-10-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Infant Formula on Energy Balance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mennella@monell.org', 'phone': '267-519-4880', 'title': 'Julia A. Mennella, PhD', 'organization': 'Monell Chemical Senses Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Type of Formula: CMF', 'description': 'infant is randomized to feed standard cow milk formula during first year of life\n\nType of Formula: infant formula', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Type of Formula: EHF', 'description': 'infant is randomized to feed extensively hydrolyzed infant formula during first year of life\n\nType of Formula: infant formula', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Growth, Weight for Length (WLZ) Z Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Weight for Length Z, 0.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 0.75 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 1.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 2.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 3.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 4.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 5.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 6.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 7.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 8.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 9.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 10.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 11.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 12.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Length Z, 18.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.018', 'ciLowerLimit': '-0.0363', 'ciUpperLimit': '-0.0002', 'statisticalMethod': 'Generalized Estimating Equation', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction.', 'nonInferiorityComment': 'A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).'}], 'paramType': 'MEAN', 'timeFrame': '0.5 to 12.5 months with followup visit at 18.5 mos', 'description': 'At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).', 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.'}, {'type': 'PRIMARY', 'title': 'Growth, Weight for Age (WAZ) Z Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Weight for Age Z score, 0.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 0.75 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.41', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.28', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 1.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 2.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 3.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 4.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 5.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 6.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 7.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 8.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 9.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 10.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 11.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 12.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Weight for Age Z score, 18.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 18.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.023', 'ciLowerLimit': '-0.0362', 'ciUpperLimit': '-0.0093', 'statisticalMethod': 'Generalized Estimating Equations', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'GEE analysis conducted on each type of Z score separately with group (CMF, EHF), time (infant age; 0.5-12.5 months) and their interaction.', 'nonInferiorityComment': 'A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos). We provide below the parameter estimates for WLZ scores only.'}], 'paramType': 'MEAN', 'timeFrame': '0.5 to 12.5 months with followup visit at 18.5 mos', 'description': 'At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).', 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.'}, {'type': 'PRIMARY', 'title': 'Growth: Length for Age (LAZ) Z Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Length for Age Z score, 0.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 0.75 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.56', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 1.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 2.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 3.5mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 4.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 5.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 6.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 7.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 8.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 9.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 10.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 11.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 12.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Length for Age Z score, 18.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.058', 'ciUpperLimit': '0.019', 'statisticalMethod': 'Generalized Estimating Equation', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'GEE analysis conducted with group (CMF, EHF), time (infant age, 0.5-12.5 months) and their interaction', 'nonInferiorityComment': 'A priori power analyses determined that a sample size of 94 is required to detect a difference of 0.67 with 90% power and a 5% type 1 error rate. We conducted an intention-to-treat (ITT) analyses on the 113 infants using separate generalized estimating equations that included treatment group (CMF, EHF), time (infant age), and group × time interaction for each type of Z score (0.5-12.5 mos).'}], 'paramType': 'MEAN', 'timeFrame': '0.5 to 12.5 months with followup visit at 18.5 mos', 'description': 'At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).', 'unitOfMeasure': 'Z score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We conducted an intention-to-treat (ITT) analyses on 113 infants regardless of study withdrawal.'}, {'type': 'PRIMARY', 'title': 'Energy Balance: Energy Intake From Infant Formula and Other Sources', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Energy Intake from Formula, 0.75 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '466', 'spread': '14', 'groupId': 'OG000'}, {'value': '383', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'Energy Intake from Other Sources, 0.75 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Energy Intake from Formula, 3.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '628', 'spread': '21', 'groupId': 'OG000'}, {'value': '596', 'spread': '21', 'groupId': 'OG001'}]}]}, {'title': 'Energy Intake from Other Sources, 3.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'spread': '5', 'groupId': 'OG000'}, {'value': '10', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'Energy Intake from Formula, 12.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '425', 'spread': '50', 'groupId': 'OG000'}, {'value': '284', 'spread': '56', 'groupId': 'OG001'}]}]}, {'title': 'Energy Intake from Other Sources, 12.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '712', 'spread': '51', 'groupId': 'OG000'}, {'value': '863', 'spread': '57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'ANOVAs were conducted with group (CMF, EHF) as the between-subjects factor.', 'statisticalMethod': 'Repeated Measures ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'We conducted a ANOVA with group (CMF, EHF) as between-subject factor.', 'nonInferiorityComment': 'ANOVA with group (CMF, EHF) as between-subjects factor were conducted on intent-to-treat sample'}], 'paramType': 'MEAN', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': "Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days", 'unitOfMeasure': 'kcal per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis (N=113).'}, {'type': 'PRIMARY', 'title': 'Energy Balance: Sleeping Energy Expenditure (SEE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Sleeping Energy Expenditure (0.75 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '206', 'spread': '6', 'groupId': 'OG000'}, {'value': '201', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'Sleeping Energy Expenditure, 3.5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '329', 'spread': '8', 'groupId': 'OG000'}, {'value': '321', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': 'Sleeping Energy Expenditure, 12.5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '507', 'spread': '11', 'groupId': 'OG000'}, {'value': '509', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.', 'nonInferiorityComment': 'ANOVA was conducted with group (CMF, EHF) as between-subjects factor on the intent-to-treat sample.'}], 'paramType': 'MEAN', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': 'Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.', 'unitOfMeasure': 'kcal per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis (N=113).'}, {'type': 'PRIMARY', 'title': 'Energy Balance: Total Energy Expenditure (TEE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Total energy expenditure, 0.75 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '283', 'spread': '18', 'groupId': 'OG000'}, {'value': '243', 'spread': '19', 'groupId': 'OG001'}]}]}, {'title': 'Total energy expenditure, 3.5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '488', 'spread': '24', 'groupId': 'OG000'}, {'value': '444', 'spread': '26', 'groupId': 'OG001'}]}]}, {'title': 'Total energy expenditure, 12.5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '859', 'spread': '42', 'groupId': 'OG000'}, {'value': '858', 'spread': '45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample', 'nonInferiorityComment': 'Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample'}], 'paramType': 'MEAN', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': 'TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method', 'unitOfMeasure': 'kcal per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis (N=113).'}, {'type': 'PRIMARY', 'title': 'Energy Balance: Energy Loss in Stools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Energy Loss in Stools, 0.75 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Energy Loss in Stools, 3.5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Energy Loss in Stools, 12.5 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.1', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample', 'nonInferiorityComment': 'Repeated Measures ANOVA conducted with group (CMF, EHF) as between-subjects factor on intent-to-treat sample'}], 'paramType': 'MEAN', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': 'Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint', 'unitOfMeasure': 'kcal per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analysis (N=113).'}, {'type': 'SECONDARY', 'title': 'Feeding Behaviors, Maternal Perceptions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Type of Formula: CMF', 'description': 'Infant is randomized to be fed standard cow milk formula during first year of life\n\nType of Formula: CMF'}, {'id': 'OG001', 'title': 'Type of Formula: EHF', 'description': 'Infant is randomized to be fed extensively protein hydrolyzed infant formula during first year of life\n\nType of Formula: EHF'}], 'classes': [{'title': 'Laissez-Faire Feeding Style, 0.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Restrictive Feeding Style, 0.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Pressure to Eat Feeding Style, 0.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.1', 'groupId': 'OG001'}]}]}, {'title': 'Responsive Feeding Styly, 0.5 mos', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0.5 months', 'description': 'Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Some mothers responded N/A on questions related to restrictive feeding styles and thus score for this subscale could not be computed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Type of Formula: CMF', 'description': 'infant is randomized to feed standard cow milk formula during first year of life\n\nType of Formula: infant formula'}, {'id': 'FG001', 'title': 'Type of Formula: EHF', 'description': 'infant is randomized to feed extensively hydrolyzed infant formula during first year of life\n\nType of Formula: infant formula'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Mother-Infant Dyads', 'groupId': 'FG000', 'numSubjects': '59'}, {'comment': 'Mother-Infant Dyads', 'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Mother-Infant Dyads', 'groupId': 'FG000', 'numSubjects': '44'}, {'comment': 'Mother-Infant Dyads', 'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'From 2012 to 2015, newly parturient women whose decision not to lactate was firmly established were recruited through ads in regional newspapers, websites and hospitals in the greater Philadelphia area.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Type of Formula: CMF', 'description': 'infant is randomized to feed standard cow milk infant formula \\[CMF\\] during first year of life\n\nType of Formula: infant formula'}, {'id': 'BG001', 'title': 'Type of Formula: EHF', 'description': 'infant is randomized to feed extensively hydrolyzed protein infant formula \\[EHF\\] first year of life\n\nType of Formula: infant formula'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '0.4', 'spread': '0.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'TAS2R38 genotype, A49P allele; infants', 'classes': [{'title': 'AA, homozygous recessive', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'AP, heterozygous', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'PP, homozygous dominant', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Between- and within-subject longitudinal trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2016-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2012-10-02', 'resultsFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-13', 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth, Weight for Length (WLZ) Z Scores', 'timeFrame': '0.5 to 12.5 months with followup visit at 18.5 mos', 'description': 'At each visit, infants were weighed and measured to monitor normal growth. These anthropometric data were converted to weight-for-length (WLZ) Zscores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).'}, {'measure': 'Growth, Weight for Age (WAZ) Z Score', 'timeFrame': '0.5 to 12.5 months with followup visit at 18.5 mos', 'description': 'At each visit, infants were weighed to monitor normal growth. These anthropometric data were converted to Weight for age Z (WAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).'}, {'measure': 'Growth: Length for Age (LAZ) Z Scores', 'timeFrame': '0.5 to 12.5 months with followup visit at 18.5 mos', 'description': 'At each visit, infants were measured to monitor normal growth. These anthropometric data were converted to Length for age Z (LAZ) Z scores using World Health Organization (WHO) growth standards. The Z-score expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean value. Normal range for Z score is -2.0 (minimum) to 2.0 (maximum).'}, {'measure': 'Energy Balance: Energy Intake From Infant Formula and Other Sources', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': "Energy intake (kcal/day) of infant formula and other sources was determined by three-day weighed bottle intake and records of the infants' intake of any liquid or food other than formula during the three days"}, {'measure': 'Energy Balance: Sleeping Energy Expenditure (SEE)', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': 'Postprandial SEE (kcal/day), a proxy for resting energy expenditure in infant, was measured for a minimum of 30 min by open-circuit, indirect calorimetry using a metabolic cart with canopy hood, in a quiet, thermal-neutral room.'}, {'measure': 'Energy Balance: Total Energy Expenditure (TEE)', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': 'TEE (kcal/day) was measured over 7 days at each of the three time points (0.75, 3.5 and12.5 mos) using the doubly labeled water method'}, {'measure': 'Energy Balance: Energy Loss in Stools', 'timeFrame': '0.75, 3.5, 12.5 mos', 'description': 'Stool EL (kcal/day) was determined from 3-day stool collection by bomb calorimetry at each timepoint'}], 'secondaryOutcomes': [{'measure': 'Feeding Behaviors, Maternal Perceptions', 'timeFrame': '0.5 months', 'description': 'Maternal perception of infant feeding behavior, using standardized questionnaires (Infant feeding style questionnaire; IFSQ); values ranged from 1 to 5; higher scores reflect more of that feeding style. Only baseline data reported herein.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Formula Feeding', 'Mother', 'Moms', 'Infants', 'Babies', 'Baby', 'growth', 'energy balance'], 'conditions': ['Development']}, 'referencesModule': {'references': [{'pmid': '21187303', 'type': 'BACKGROUND', 'citation': 'Mennella JA, Ventura AK, Beauchamp GK. Differential growth patterns among healthy infants fed protein hydrolysate or cow-milk formulas. Pediatrics. 2011 Jan;127(1):110-8. doi: 10.1542/peds.2010-1675. Epub 2010 Dec 27.'}, {'pmid': '8960567', 'type': 'BACKGROUND', 'citation': 'Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996 Dec;17(6):386-91. doi: 10.1097/00004703-199612000-00003.'}, {'pmid': '21310829', 'type': 'BACKGROUND', 'citation': 'Mennella JA, Lukasewycz LD, Castor SM, Beauchamp GK. The timing and duration of a sensitive period in human flavor learning: a randomized trial. Am J Clin Nutr. 2011 May;93(5):1019-24. doi: 10.3945/ajcn.110.003541. Epub 2011 Feb 10.'}, {'pmid': '30295700', 'type': 'RESULT', 'citation': 'Mennella JA, Inamdar L, Pressman N, Schall JI, Papas MA, Schoeller D, Stallings VA, Trabulsi JC. Type of infant formula increases early weight gain and impacts energy balance: a randomized controlled trial. Am J Clin Nutr. 2018 Nov 1;108(5):1015-1025. doi: 10.1093/ajcn/nqy188.'}, {'pmid': '30629845', 'type': 'RESULT', 'citation': 'Mennella JA, Papas MA, Reiter AR, Stallings VA, Trabulsi JC. Early rapid weight gain among formula-fed infants: Impact of formula type and maternal feeding styles. Pediatr Obes. 2019 Jun;14(6):e12503. doi: 10.1111/ijpo.12503. Epub 2019 Jan 10.'}, {'pmid': '41082983', 'type': 'DERIVED', 'citation': 'Decker JE, Mennella JA, Brewer BC, Robson SM, Millen AE, Delahanty MT, Smethers AD, Trabulsi JC. Association Between Diet Patterns of Human Infants and Growth Differs Across Randomized Formula Groups in the First 18.5 Months. J Nutr. 2025 Dec;155(12):4390-4400. doi: 10.1016/j.tjnut.2025.10.007. Epub 2025 Oct 11.'}, {'pmid': '37292800', 'type': 'DERIVED', 'citation': 'Mennella JA, Smethers AD, Delahanty MT, Stallings VA, Trabulsi JC. Glutamic Acid Intake by Formula-Fed Infants: Are Acceptable Daily Intakes Feasible? Res Sq [Preprint]. 2023 May 17:rs.3.rs-2907953. doi: 10.21203/rs.3.rs-2907953/v1.'}, {'pmid': '32553836', 'type': 'DERIVED', 'citation': 'Mennella JA, Reiter A, Brewer B, Pohlig RT, Stallings VA, Trabulsi JC. Early Weight Gain Forecasts Accelerated Eruption of Deciduous Teeth and Later Overweight Status during the First Year. J Pediatr. 2020 Oct;225:174-181.e2. doi: 10.1016/j.jpeds.2020.06.019. Epub 2020 Jun 15.'}]}, 'descriptionModule': {'briefSummary': 'The overarching goal of the research we propose here is to conduct a randomized clinical trial to specify the physiologic and behavioral mechanisms by which infant-formula composition affects all aspects of energy balance and growth during the first years of life.', 'detailedDescription': 'This is a randomized clinical trial of infants whose parents decided to formula feed them; mother-infant dyads will be randomized when infant is 2 weeks of age to one of 2 groups. The groups will differ in the composition of the formula fed to the infant during the first year of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Weeks', 'minimumAge': '1 Week', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n1. A healthy, term (≥37 and ≤42 week gestation at birth), singleton infant.\n2. Birth weight between 2500 - 4500 grams.\n3. At the time of enrollment, infant must be ≤14 days old (Date of birth=day 0).\n4. Mother must be 18 years or older.\n5. Infant must be consuming a standard cow's milk protein infant formula and have been receiving a standard cow's milk protein infant formula for at least the past 2 days prior to enrollment.\n\nExclusion Criteria\n\n1. Mother had gestational diabetes during pregnancy\n2. Infant has condition requiring infant feedings other than feeding cow milk formula from a bottle.\n3. Infant has major congenital malformations (i.e. cleft palate, hemangiomas, extremity malformation).\n4. Infant has suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus).\n5. Infant has evidence of significant cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases. For example, infant must not be receiving insulin or growth hormone.\n6. Dyad be the relative (son, daughter, niece, nephew, cousin, aunt, uncle, sibling) of ancillary personnel connected with the study."}, 'identificationModule': {'nctId': 'NCT01700205', 'acronym': 'GRO', 'briefTitle': 'Effect of Infant Formula on Energy Balance', 'organization': {'class': 'OTHER', 'fullName': 'Monell Chemical Senses Center'}, 'officialTitle': 'Impact of Diet Composition on Energy Balance and Satiety During Infancy', 'orgStudyIdInfo': {'id': 'HD072307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Type of Formula: CMF', 'description': 'Infants are randomized to feed standard cow milk formula during first year of life', 'interventionNames': ['Other: Type of Formula']}, {'type': 'EXPERIMENTAL', 'label': 'Type of Formula: EHF', 'description': 'Infants are randomized to feed extensively hydrolyzed infant formula during first year of life', 'interventionNames': ['Other: Type of Formula']}], 'interventions': [{'name': 'Type of Formula', 'type': 'OTHER', 'otherNames': ['cow milk formula (CMF)', 'protein hydrolysate formula (EHF)'], 'description': 'infant formula', 'armGroupLabels': ['Type of Formula: CMF', 'Type of Formula: EHF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Monell Chemical Senses Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Julie A Mennella, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monell Chemical Senses Center'}, {'name': 'Jillian Trabulsi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Energy balance measures at 0.75, 3.5 and 12.5 months of age'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monell Chemical Senses Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Delaware', 'class': 'OTHER'}, {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Member', 'investigatorFullName': 'Julie A. Mennella, PhD', 'investigatorAffiliation': 'Monell Chemical Senses Center'}}}}