Ignite Creation Date:
2025-12-25 @ 3:17 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT02033005
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2014-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Newborn Feeding and Infant Phenotype
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christopher.gale@imperial.ac.uk', 'phone': '+44 (0) 2033153519', 'title': 'Dr Chris Gale', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years and 2 months', 'eventGroups': [{'id': 'EG000', 'title': 'Breastfed Infants', 'description': '\\>80% of feeds consisting of breast milk at both scanning points', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mixed-fed Infants', 'description': '20%-80% of feeds consisting of breast milk.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Formula-fed Infants', 'description': '\\>80% of feeds consisting of formula milk at both scanning points', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Total Adipose Tissue Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Breastfed', 'description': '\\>80% of feeds consisting of breastmilk at both scanning points'}, {'id': 'OG001', 'title': 'Mixed-fed Infants', 'description': '20%-80% of feeds consisting of breast milk.'}, {'id': 'OG002', 'title': 'Formula-fed Infants', 'description': '\\>80% of feeds consisting of formula milk at both scanning points'}], 'classes': [{'categories': [{'measurements': [{'value': '0.718', 'groupId': 'OG000', 'lowerLimit': '0.508', 'upperLimit': '0.938'}, {'value': '0.901', 'groupId': 'OG001', 'lowerLimit': '0.452', 'upperLimit': '1.053'}, {'value': '0.775', 'groupId': 'OG002', 'lowerLimit': '0.532', 'upperLimit': '0.971'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Between birth and 6-12 weeks age', 'description': 'Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.', 'unitOfMeasure': 'Litres', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Reduced participant number for this analysis represents missing data for some infants at one scan point'}, {'type': 'SECONDARY', 'title': 'Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Breastfed Infants', 'description': '\\>80% of feeds consisting of breastmilk at both scanning points'}, {'id': 'OG001', 'title': 'Mixed-fed Infants', 'description': '20%-80% of feeds consisting of breast milk.'}, {'id': 'OG002', 'title': 'Formula-fed Infants', 'description': '\\>80% of feeds consisting of formula milk at both scanning points'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.07', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '-0.02'}, {'value': '-0.06', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '-0.02'}, {'value': '-0.03', 'groupId': 'OG002', 'lowerLimit': '-0.07', 'upperLimit': '0.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Between birth and 6-12 weeks age', 'description': 'Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging', 'unitOfMeasure': 'no unit (ratio)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Reduced participant number for this analysis represents missing data for some infants at one scan point'}, {'type': 'SECONDARY', 'title': 'Change in Intrahepatocellular Lipid Compared to Breastfed Infants.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Breastfed Infants', 'description': '\\>80% of feeds consisting of breastmilk at both scanning points'}, {'id': 'OG001', 'title': 'Mixed-fed Infants', 'description': '20%-80% of feeds consisting of breast milk.'}, {'id': 'OG002', 'title': 'Formula-fed Infants', 'description': '\\>80% of feeds consisting of formula milk at both scanning points'}], 'classes': [{'categories': [{'measurements': [{'value': '1.192', 'groupId': 'OG000', 'lowerLimit': '0.226', 'upperLimit': '1.967'}, {'value': '-0.054', 'groupId': 'OG001', 'lowerLimit': '-.672', 'upperLimit': '1.837'}, {'value': '1.095', 'groupId': 'OG002', 'lowerLimit': '-0.280', 'upperLimit': '1.746'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Between birth and 6-12 weeks age', 'description': 'Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy', 'unitOfMeasure': 'ratio of CH2 to water', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Reduced number of participants due to missing intrahepatocellular lipid data in some cases'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Breastfed Infants', 'description': '\\>80% of feeds consisting of breast milk at both scanning points'}, {'id': 'FG001', 'title': 'Mixed-fed Infants', 'description': '20%-80% of feeds consisting of breast milk.'}, {'id': 'FG002', 'title': 'Formula-fed Infants', 'description': '\\>80% of feeds consisting of formula milk at both scanning points'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Participants consisted of healthy, full term, appropriate weight-for-gestational age infants from 2 cohorts: recruited between November 1999 and October 2001 at the Hammersmith Hospital, and between March 2010 and May 2012 from the postnatal ward at Chelsea and Westminster Hospital.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Breastfed Infants', 'description': '\\>80% of feeds consisting of breast milk at both scanning points'}, {'id': 'BG001', 'title': 'Mixed-fed Infants', 'description': '20%-80% of feeds consisting of breast milk.'}, {'id': 'BG002', 'title': 'Formula-fed Infants', 'description': '\\>80% of feeds consisting of formula milk at both scanning points'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '18'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '16', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '20'}, {'value': '13', 'groupId': 'BG003', 'lowerLimit': '9', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '3.647', 'spread': '0.421', 'groupId': 'BG000'}, {'value': '3.332', 'spread': '0.478', 'groupId': 'BG001'}, {'value': '3.622', 'spread': '0.595', 'groupId': 'BG002'}, {'value': '3.598', 'spread': '0.500', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Length', 'classes': [{'categories': [{'measurements': [{'value': '0.533', 'spread': '0.023', 'groupId': 'BG000'}, {'value': '0.510', 'spread': '0.025', 'groupId': 'BG001'}, {'value': '0.523', 'spread': '0.025', 'groupId': 'BG002'}, {'value': '0.527', 'spread': '0.025', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Head circumference', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '35.0', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '36', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '36.1', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.710', 'groupId': 'BG000', 'lowerLimit': '0.632', 'upperLimit': '0.899'}, {'value': '0.802', 'groupId': 'BG001', 'lowerLimit': '0.620', 'upperLimit': '0.949'}, {'value': '0.722', 'groupId': 'BG002', 'lowerLimit': '0.613', 'upperLimit': '0.913'}, {'value': '0.718', 'groupId': 'BG003', 'lowerLimit': '0.621', 'upperLimit': '0.921'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'l', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total adipose tissue mass %', 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'BG000', 'lowerLimit': '16.3', 'upperLimit': '19.8'}, {'value': '21.3', 'groupId': 'BG001', 'lowerLimit': '18.9', 'upperLimit': '22.1'}, {'value': '18.3', 'groupId': 'BG002', 'lowerLimit': '16.6', 'upperLimit': '21.7'}, {'value': '18.1', 'groupId': 'BG003', 'lowerLimit': '16.4', 'upperLimit': '21.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Percentage of mass', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Superficial subcutaneous abdominal adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.098', 'groupId': 'BG000', 'lowerLimit': '0.077', 'upperLimit': '0.122'}, {'value': '0.110', 'groupId': 'BG001', 'lowerLimit': '0.090', 'upperLimit': '0.116'}, {'value': '0.103', 'groupId': 'BG002', 'lowerLimit': '0.075', 'upperLimit': '0.14'}, {'value': '0.101', 'groupId': 'BG003', 'lowerLimit': '0.077', 'upperLimit': '0.129'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Superficial subcutaneous non-abdominal adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.512', 'groupId': 'BG000', 'lowerLimit': '0.454', 'upperLimit': '0.680'}, {'value': '0.572', 'groupId': 'BG001', 'lowerLimit': '0.423', 'upperLimit': '0.692'}, {'value': '0.521', 'groupId': 'BG002', 'lowerLimit': '0.452', 'upperLimit': '0.648'}, {'value': '0.512', 'groupId': 'BG003', 'lowerLimit': '0.446', 'upperLimit': '0.669'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Deep subcutaneous abdominal adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'groupId': 'BG000', 'lowerLimit': '0.011', 'upperLimit': '0.021'}, {'value': '0.013', 'groupId': 'BG001', 'lowerLimit': '0.011', 'upperLimit': '0.024'}, {'value': '0.019', 'groupId': 'BG002', 'lowerLimit': '0.011', 'upperLimit': '0.022'}, {'value': '0.016', 'groupId': 'BG003', 'lowerLimit': '0.011', 'upperLimit': '0.022'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Deep subcutaneous non-abdominal adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.012', 'groupId': 'BG000', 'lowerLimit': '0.009', 'upperLimit': '0.015'}, {'value': '0.012', 'groupId': 'BG001', 'lowerLimit': '0.012', 'upperLimit': '0.014'}, {'value': '0.013', 'groupId': 'BG002', 'lowerLimit': '0.011', 'upperLimit': '0.016'}, {'value': '0.013', 'groupId': 'BG003', 'lowerLimit': '0.010', 'upperLimit': '0.015'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Internal abdominal adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.017', 'groupId': 'BG000', 'lowerLimit': '0.013', 'upperLimit': '0.022'}, {'value': '0.022', 'groupId': 'BG001', 'lowerLimit': '0.014', 'upperLimit': '0.027'}, {'value': '0.017', 'groupId': 'BG002', 'lowerLimit': '0.012', 'upperLimit': '0.022'}, {'value': '0.017', 'groupId': 'BG003', 'lowerLimit': '0.013', 'upperLimit': '0.023'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Internal non-abdominal adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.054', 'groupId': 'BG000', 'lowerLimit': '0.044', 'upperLimit': '0.065'}, {'value': '0.061', 'groupId': 'BG001', 'lowerLimit': '0.051', 'upperLimit': '0.078'}, {'value': '0.052', 'groupId': 'BG002', 'lowerLimit': '0.047', 'upperLimit': '0.072'}, {'value': '0.054', 'groupId': 'BG003', 'lowerLimit': '0.045', 'upperLimit': '0.070'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total subcutaneous adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.633', 'groupId': 'BG000', 'lowerLimit': '0.570', 'upperLimit': '0.833'}, {'value': '0.718', 'groupId': 'BG001', 'lowerLimit': '0.484', 'upperLimit': '0.950'}, {'value': '0.654', 'groupId': 'BG002', 'lowerLimit': '0.529', 'upperLimit': '0.832'}, {'value': '0.644', 'groupId': 'BG003', 'lowerLimit': '0.553', 'upperLimit': '0.835'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Total internal adipose tissue', 'classes': [{'categories': [{'measurements': [{'value': '0.070', 'groupId': 'BG000', 'lowerLimit': '0.056', 'upperLimit': '0.086'}, {'value': '0.084', 'groupId': 'BG001', 'lowerLimit': '0.059', 'upperLimit': '0.106'}, {'value': '0.069', 'groupId': 'BG002', 'lowerLimit': '0.055', 'upperLimit': '0.091'}, {'value': '0.070', 'groupId': 'BG003', 'lowerLimit': '0.056', 'upperLimit': '0.093'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Litres', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Intrahepatocellular lipid', 'classes': [{'categories': [{'measurements': [{'value': '0.662', 'groupId': 'BG000', 'lowerLimit': '0.353', 'upperLimit': '1.965'}, {'value': '1.126', 'groupId': 'BG001', 'lowerLimit': '0.695', 'upperLimit': '1.573'}, {'value': '1.197', 'groupId': 'BG002', 'lowerLimit': '0.710', 'upperLimit': '1.650'}, {'value': '0.949', 'groupId': 'BG003', 'lowerLimit': '0.521', 'upperLimit': '1.711'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Ratio of CH2 (methylene) to H2O (water)', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine Stool Breast milk'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2014-01-09', 'resultsFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-26', 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Total Adipose Tissue Volume', 'timeFrame': 'Between birth and 6-12 weeks age', 'description': 'Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.'}], 'secondaryOutcomes': [{'measure': 'Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.', 'timeFrame': 'Between birth and 6-12 weeks age', 'description': 'Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging'}, {'measure': 'Change in Intrahepatocellular Lipid Compared to Breastfed Infants.', 'timeFrame': 'Between birth and 6-12 weeks age', 'description': 'Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Body Composition', 'Adipose Tissue', 'Intrahepatocellular Lipid', 'Infant', 'Magnetic Resonance Imaging', 'Magnetic Resonance Spectroscopy'], 'conditions': ['Breast Feeding']}, 'referencesModule': {'references': [{'pmid': '24572562', 'type': 'DERIVED', 'citation': 'Gale C, Thomas EL, Jeffries S, Durighel G, Logan KM, Parkinson JR, Uthaya S, Santhakumaran S, Bell JD, Modi N. Adiposity and hepatic lipid in healthy full-term, breastfed, and formula-fed human infants: a prospective short-term longitudinal cohort study. Am J Clin Nutr. 2014 May;99(5):1034-40. doi: 10.3945/ajcn.113.080200. Epub 2014 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'Breast feeding is believed to be beneficial to long-term health but how these effects are mediated is unknown. I suggest that this may be through effects on body composition and metabolism.\n\nI will compare adipose tissue and liver fat deposition in healthy, full term breast and formula fed infants babies shortly after birth and around 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy baby\n* Term baby\n* Appropriate weight for gestational age (UK - WHO 2009 growth charts)\n\nExclusion Criteria:\n\n* Infants of diabetic mothers\n* Infants of smokers\n* Infants fed non-commercial or non-cows milk based infant formulae'}, 'identificationModule': {'nctId': 'NCT02033005', 'briefTitle': 'Newborn Feeding and Infant Phenotype', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Newborn Feeding and Infant Phenotype', 'orgStudyIdInfo': {'id': 'CRO1461'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breastfed infants', 'description': '\\>80% of feeds consisting of breast milk at both scanning points'}, {'label': 'Formula-fed infants', 'description': '\\>80% of feeds consisting of formula milk at both scanning points'}, {'label': 'Mixed-fed infants', 'description': '20%-80% of feeds consisting of breast milk.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Neena Modi, MBBS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}