Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-11 @ 7:43 PM
Study NCT ID:
NCT03704051
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2018-10-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Breast Versus Bottle Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D001903', 'term': 'Bottle Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'akventur@calpoly.edu', 'phone': '(805) 756-5693', 'title': 'Dr. Alison Ventura', 'organization': 'California Polytechnic State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study consisted of mothers who were exclusively or predominantly breastfeeding and who fed expressed breast milk (not formula) when bottle-feeding.'}}, 'adverseEventsModule': {'timeFrame': "For the duration of each participant's participation in the study: ~1 week", 'description': 'Definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': 'Breastfeeding Condition - Mothers', 'description': 'Mother-infant dyads were observed while breastfeeding during one visit to our laboratory and bottle-feeding expressed breast milk during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Breastfeeding Condition - Infants', 'description': 'Mother-infant dyads were observed while breastfeeding during one visit to our laboratory and bottle-feeding expressed breast milk during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Bottle-feeding Condition - Mothers', 'description': 'Mother-infant dyads were observed while bottle-feeding expressed breast milk during one visit to our laboratory and breastfeeding during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Bottle-feeding Condition - Infants', 'description': 'Mother-infant dyads were observed while bottle-feeding expressed breast milk during one visit to our laboratory and breastfeeding during the other. All mother-infant dyads participated in both conditions. Adverse Event data are reported for mothers (n = 47) and infants (n = 47) separately.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 0, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Infant Intake During the Observed Feeding (mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}, {'units': 'dyads', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast- Versus Bottle-feeding', 'description': 'This was a within-subject study; all mother-infant dyads were exposed to both conditions: breastfeeding versus bottle-feeding with expressed breast milk\n\nOrder of presentation was counterbalanced.'}], 'classes': [{'title': 'Breastfeeding Condition', 'categories': [{'measurements': [{'value': '91.9', 'spread': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Bottle-feeding Condition', 'categories': [{'measurements': [{'value': '87.6', 'spread': '5.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.634', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'All models adjusted for order of conditions, time since last feeding and infant age.', 'nonInferiorityComment': 'A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.'}], 'paramType': 'MEAN', 'timeFrame': '2-hour period', 'description': 'For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dyads', 'denomUnitsSelected': 'dyads'}, {'type': 'PRIMARY', 'title': 'Maternal Sensitivity to Infant Cues', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}, {'units': 'dyads', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast- Versus Bottle-feeding Conditions', 'description': 'This was a within-subject study; all infants were exposed to both conditions: breastfeeding versus bottle-feeding with expressed breast milk\n\nOrder of presentation was counterbalanced.'}], 'classes': [{'title': 'Breastfeeding Condition', 'categories': [{'measurements': [{'value': '14.7', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Bottle-feeding Condition', 'categories': [{'measurements': [{'value': '14.3', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.115', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'statisticalComment': 'All models adjusted for order of conditions, time since last feeding and infant age.', 'nonInferiorityComment': 'A priori power analysis based on pilot testing with 12 dyads indicated that a sample size of at least 40 dyads would provide 80% power to detect significant within-subjects (condition, i.e., breastfeeding directly from the breast vs. bottle-feeding expressed breast milk) effects at an α = 0.05 Type I error level.'}], 'paramType': 'MEAN', 'timeFrame': '2-hour period', 'description': "Mother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'dyads', 'denomUnitsSelected': 'dyads'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Breastfeeding First, Then Bottle-feeding', 'description': 'Mother-infant dyads in this group breastfed during the first visit, then bottle-fed expressed breast milk during the second visit.'}, {'id': 'FG001', 'title': 'Bottle-Feeding First, Then Breastfeeding', 'description': 'Mother-infant dyads in this group bottle-fed expressed breast milk during the first visit, then breast-fed during the second visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '24 mother-infant dyads (24 mothers + 24 infants = 48 participants total) participated in the first visit', 'groupId': 'FG000', 'numSubjects': '48'}, {'comment': '23 mother-infant dyads (23 mothers + 23 infants = 48 participants total) participated in the first visit', 'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 mother-infant dyads (2 mothers + 2 infants = 4 participants total) in this group dropped out of the study after the first visit', 'groupId': 'FG000', 'numSubjects': '44'}, {'comment': '0 mother-infant dyads in this group dropped out of the study after the first visit', 'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Mothers of infants under 6 months of age were recruited through advertisements on social media platforms (e.g. Facebook and Instagram); advertisements in local Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) clinics; announcements in birthing, breastfeeding and parenting classes; and flyers displayed at local businesses.', 'preAssignmentDetails': 'There were no significant events in the study (for example, wash out, run-in) that occurred after participant enrollment, but prior to the first within-subject condition.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'This was a within-subject study; all mother-infant dyads (47 mothers + 47 infants = 94 participants total) were exposed to both conditions and the order of presentation was counterbalanced across dyads. Because all dyads were randomized to receive all interventions, all will be combined into one arm/group for the summary that follows.\n\nMode of Feeding (breastfeeding versus bottle-feeding): Infants will be breastfed during one lab visit and bottle-fed (with expressed breast milk) during the other.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '32.4', 'spread': '4.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mother Age at Study Entry', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are for mothers only (n = 47)'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Infant Age at Study Entry', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are for infants only (n = 47)'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are for mothers only (n = 47)'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data are for infants only (n = 47)'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '86', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'All data collection took place in San Luis Obispo and Santa Barbara Counties, California', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline analysis population included mothers (n = 47) and their healthy infants \\<6 months of age (n = 47).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-05', 'size': 256944, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2018-10-10T13:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2018-10-08', 'resultsFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2018-10-10', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-21', 'studyFirstPostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant Intake During the Observed Feeding (mL)', 'timeFrame': '2-hour period', 'description': 'For both breast- and bottle-feedings, infant intake will be assessed by pre- and post-weighing the baby on an infant scale (model 374; Seca, Hamburg, Germany). During bottle-feedings, we will also note whether the infant finishes the bottle.'}, {'measure': 'Maternal Sensitivity to Infant Cues', 'timeFrame': '2-hour period', 'description': "Mother and infant behavior during each feeding will be coded using the Nursing Child Assessment Parent-Child Interaction - Feeding Scale (NCAFS). This scale contains six subscales, four of which describe maternal attributes (Sensitivity to Cues, Response to Child's Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering) and two of which describe infant attributes (Clarity of Cues and Responsiveness to Caregiver). The proposed analysis will focus on the Sensitivity to Cues subscale, which measures the degree to which the mother is able to understand and respond to her child's cues. This scale provides a global measure of how sensitive the mother is to the infant's needs during the feeding interaction. Possible score range is 0-16, which is derived from summing together maternal scores for each of the 16 subscale items. Higher scores indicate greater sensitivity to infant cues."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infant feeding', 'feeding interactions', 'maternal feeding practices', 'breastfeeding', 'bottle-feeding'], 'conditions': ['Breastfeeding', 'Bottle Feeding']}, 'referencesModule': {'references': [{'pmid': '33939269', 'type': 'RESULT', 'citation': 'Ventura A, Hupp M, Lavond J. Mother-infant interactions and infant intake during breastfeeding versus bottle-feeding expressed breast milk. Matern Child Nutr. 2021 Oct;17(4):e13185. doi: 10.1111/mcn.13185. Epub 2021 May 3.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of feeding mode (breast- versus bottle-feeding) on the quality and outcome of infant feeding interactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '0 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A convenience sample of mother-infant dyads residing within 50 miles of California Polytechnic State University.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mothers 18-40 years of age\n* Infants 0-24 weeks of age\n* Infants who have not yet been introduced to complementary foods and beverages\n* Dyads are breast- and bottle-feeding\n* Mother is predominantly or solely responsible for infant feeding\n\nExclusion Criteria:\n\n* preterm birth (i.e., gestational age \\<37 weeks)\n* low birth weight (\\<2500 g)\n* maternal smoking during pregnancy\n* current or past medical conditions that interfere with oral feeding\n* history of slow growth or failure to thrive\n* weight for length percentile \\<5th\n* diagnosed developmental delay (e.g., Down's syndrome)"}, 'identificationModule': {'nctId': 'NCT03704051', 'briefTitle': 'Breast Versus Bottle Study', 'organization': {'class': 'OTHER', 'fullName': 'California Polytechnic State University-San Luis Obispo'}, 'officialTitle': 'Breast Versus Bottle Study', 'orgStudyIdInfo': {'id': '2018-143-CO'}, 'secondaryIdInfos': [{'id': 'R03HD096164', 'link': 'https://reporter.nih.gov/quickSearch/R03HD096164', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breastfeeding First, then Bottle-feeding', 'description': 'Mother-infant dyads were observed while breastfeeding during their first visit to our laboratory and were observed while bottle-feeding expressed breast milk during their second visit to our laboratory.', 'interventionNames': ['Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)']}, {'label': 'Bottle-feeding First, then Breastfeeding', 'description': 'Mother-infant dyads were observed while bottle-feeding expressed breast milk during their first visit to our laboratory and were observed while breastfeeding during their second visit to our laboratory.', 'interventionNames': ['Behavioral: Mode of Feeding (breastfeeding versus bottle-feeding)']}], 'interventions': [{'name': 'Mode of Feeding (breastfeeding versus bottle-feeding)', 'type': 'BEHAVIORAL', 'description': 'Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.', 'armGroupLabels': ['Bottle-feeding First, then Breastfeeding', 'Breastfeeding First, then Bottle-feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93401', 'city': 'San Luis Obispo', 'state': 'California', 'country': 'United States', 'facility': 'Healthy Kids Laboratory within the French Hospital Copeland Health Education Pavilion', 'geoPoint': {'lat': 35.28275, 'lon': -120.65962}}], 'overallOfficials': [{'name': 'Alison K Ventura, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cal Poly'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not currently plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'California Polytechnic State University-San Luis Obispo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Alison Ventura', 'investigatorAffiliation': 'California Polytechnic State University-San Luis Obispo'}}}}