Newborn Feeding and Infant Phenotype

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02033005
• Collaborator: Chelsea and Westminster NHS Foundation Trust (Other)
• Enrollment: 124
• Location: 1
• Duration (Months): 28
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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.

I 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Feeding

Study Design

• Study Type: Observational
• Actual Enrollment: 124 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Newborn Feeding and Infant Phenotype
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Breastfed infants >80% of feeds consisting of breast milk at both scanning points
Formula-fed infants >80% of feeds consisting of formula milk at both scanning points
Mixed-fed infants 20%-80% of feeds consisting of breast milk.

Outcome Measures

Primary Outcome Measures

1. Change in Total Adipose Tissue Volume [Between birth and 6-12 weeks age]

   Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.

Secondary Outcome Measures

1. Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants. [Between birth and 6-12 weeks age]

   Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging

2. Change in Intrahepatocellular Lipid Compared to Breastfed Infants. [Between birth and 6-12 weeks age]

   Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 4 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy baby

• Term baby

• Appropriate weight for gestational age (UK - WHO 2009 growth charts)

Exclusion Criteria:

• Infants of diabetic mothers

• Infants of smokers

• Infants fed non-commercial or non-cows milk based infant formulae

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chelsea and Westminster Hospital NHS Foundation Trust	London		United Kingdom	SW10 9NH

Sponsors and Collaborators

• Imperial College London
• Chelsea and Westminster NHS Foundation Trust

Investigators

• Principal Investigator: Neena Modi, MBBS, MD, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT02033005
• Other Study ID Numbers: CRO1461
• First Posted: Jan 10, 2014
• Last Update Posted: Jun 7, 2019
• Last Verified: Jan 1, 2014

• Keywords provided by Imperial College London: Body Composition; Adipose Tissue; Intrahepatocellular Lipid; Infant; Magnetic Resonance Imaging; Magnetic Resonance Spectroscopy

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Breastfed Infants	Mixed-fed Infants	Formula-fed Infants
Arm/Group Description	>80% of feeds consisting of breast milk at both scanning points	20%-80% of feeds consisting of breast milk.	>80% of feeds consisting of formula milk at both scanning points
Period Title: Overall Study
STARTED	80	9	35
COMPLETED	36	9	25
NOT COMPLETED	44	0	10

Baseline Characteristics

Arm/Group Title	Breastfed Infants	Mixed-fed Infants	Formula-fed Infants	Total
Arm/Group Description	>80% of feeds consisting of breast milk at both scanning points	20%-80% of feeds consisting of breast milk.	>80% of feeds consisting of formula milk at both scanning points	Total of all reporting groups
Overall Participants	36	9	25	70
Age (Count of Participants)
<=18 years	36 100%	9 100%	25 100%	70 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (Days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Days]	13	2	16	13
Sex: Female, Male (Count of Participants)
Female	11 30.6%	4 44.4%	15 60%	30 42.9%
Male	25 69.4%	5 55.6%	10 40%	40 57.1%
Region of Enrollment (participants) [Number]
United Kingdom	36 100%	9 100%	25 100%	70 100%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	3.647 (0.421)	3.332 (0.478)	3.622 (0.595)	3.598 (0.500)
Length (m) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [m]	0.533 (0.023)	0.510 (0.025)	0.523 (0.025)	0.527 (0.025)
Head circumference (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	36.5 (1.4)	35.0 (1.7)	36 (1.6)	36.1 (1.6)
Total adipose tissue (l) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [l]	0.710	0.802	0.722	0.718
Total adipose tissue mass % (Percentage of mass) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Percentage of mass]	17.5	21.3	18.3	18.1
Superficial subcutaneous abdominal adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.098	0.110	0.103	0.101
Superficial subcutaneous non-abdominal adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.512	0.572	0.521	0.512
Deep subcutaneous abdominal adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.015	0.013	0.019	0.016
Deep subcutaneous non-abdominal adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.012	0.012	0.013	0.013
Internal abdominal adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.017	0.022	0.017	0.017
Internal non-abdominal adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.054	0.061	0.052	0.054
Total subcutaneous adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.633	0.718	0.654	0.644
Total internal adipose tissue (Litres) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Litres]	0.070	0.084	0.069	0.070
Intrahepatocellular lipid (Ratio of CH2 (methylene) to H2O (water)) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Ratio of CH2 (methylene) to H2O (water)]	0.662	1.126	1.197	0.949

Outcome Measures

1. Primary Outcome

Title	Change in Total Adipose Tissue Volume
Description	Difference in total adipose tissue volume, measured using whole body magnetic resonance imaging.
Time Frame	Between birth and 6-12 weeks age

Outcome Measure Data

Analysis Population Description

Reduced participant number for this analysis represents missing data for some infants at one scan point

Arm/Group Title	Breastfed	Mixed-fed Infants	Formula-fed Infants
Arm/Group Description	>80% of feeds consisting of breastmilk at both scanning points	20%-80% of feeds consisting of breast milk.	>80% of feeds consisting of formula milk at both scanning points
Measure Participants	35	9	24
Median (Inter-Quartile Range) [Litres]	0.718	0.901	0.775

2. Secondary Outcome

Title	Change in Regional Adipose Tissue Distribution Compared to Breastfed Infants.
Description	Change in regional adipose tissue distribution (ratio of internal abdominal to total subcutaneous abdominal adipose tissue) measured using whole body magnetic resonance imaging
Time Frame	Between birth and 6-12 weeks age

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Breastfed Infants	Mixed-fed Infants	Formula-fed Infants
Arm/Group Description	>80% of feeds consisting of breastmilk at both scanning points	20%-80% of feeds consisting of breast milk.	>80% of feeds consisting of formula milk at both scanning points
Measure Participants	35	9	24
Median (Inter-Quartile Range) [no unit (ratio)]	-0.07	-0.06	-0.03

3. Secondary Outcome

Title	Change in Intrahepatocellular Lipid Compared to Breastfed Infants.
Description	Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy
Time Frame	Between birth and 6-12 weeks age

Outcome Measure Data

Analysis Population Description

Reduced number of participants due to missing intrahepatocellular lipid data in some cases

Arm/Group Title	Breastfed Infants	Mixed-fed Infants	Formula-fed Infants
Arm/Group Description	>80% of feeds consisting of breastmilk at both scanning points	20%-80% of feeds consisting of breast milk.	>80% of feeds consisting of formula milk at both scanning points
Measure Participants	30	4	20
Median (Inter-Quartile Range) [difference in ratio CH2 to water]	1.192	-0.054	1.095

Adverse Events

Arm/Group Title	Breastfed Infants		Mixed-fed Infants		Formula-fed Infants
Arm/Group Description	>80% of feeds consisting of breast milk at both scanning points		20%-80% of feeds consisting of breast milk.		>80% of feeds consisting of formula milk at both scanning points
All Cause Mortality
	Breastfed Infants		Mixed-fed Infants		Formula-fed Infants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/9 (0%)		0/25 (0%)
Serious Adverse Events
	Breastfed Infants		Mixed-fed Infants		Formula-fed Infants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/9 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Breastfed Infants		Mixed-fed Infants		Formula-fed Infants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/9 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.