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Newborn Feeding and Infant Phenotype

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ClinicalTrials.gov Identifier: NCT02033005
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Chelsea and Westminster NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London

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
Breast Feeding

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Study Type : Observational
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Newborn Feeding and Infant Phenotype
Study Start Date : March 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Group/Cohort
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.



Primary Outcome Measures :
  1. Change in Total Adipose Tissue Volume [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Between birth and 6-12 weeks age ]
    Change in intrahepatocellular lipid (IHCL) compared to breastfed infants, measured using in-vivo hepatic magnetic resonance spectroscopy


Biospecimen Retention:   Samples Without DNA
Urine Stool Breast milk


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy, full term, appropriate weight for gestational age infants recruited on the postnatal ward at Chelsea and Westminster Hospital, London, UK.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033005


Locations
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United Kingdom
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
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Principal Investigator: Neena Modi, MBBS, MD Imperial College London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02033005     History of Changes
Other Study ID Numbers: CRO1461
First Posted: January 10, 2014    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: June 7, 2019
Last Verified: January 2014
Keywords provided by Imperial College London:
Body Composition
Adipose Tissue
Intrahepatocellular Lipid
Infant
Magnetic Resonance Imaging
Magnetic Resonance Spectroscopy