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Sponsored by: |
Institute of Child Health |
Information provided by: | Institute of Child Health |
ClinicalTrials.gov Identifier: | NCT00134771 |
The purpose of this study was to determine whether giving a nutrient enriched formula to infants born small-for-gestational age benefits blood pressure, growth and body composition by six months of age.
Condition | Intervention |
Birth Weight |
Drug: Nutrient enriched infant formula |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | June 2003 |
Infants born small for gestational age often show impaired growth during childhood and reduced height as adults. Infants who are breast-fed from birth show greater 'catch-up' growth during the first few months of life than those who are formula fed but it is not clear what factors in breast milk (ie protein, nucleotides, LCPUFAs) are responsible for this 'catch-up' growth. This RCT compares the effects of using an enriched formula with increased protein and modified triglyceride (palmitate predominantly in Sn-2 position) against a standard infant formula from birth to six months on infants whose birth weights are below the 20th centiles for gestational age.
Infants are measured by a research midwife within 10 days of birth (at randomisation), 8, 16 and 26 weeks of age. At randomisation consent from the mother is taken and information collected about the pregnancy, social, demographic and medical data. At this and each further visit anthropometric measurements including skinfolds will be collected in addition to blood pressure and bio-electrical impedence at six months. A sub-sample of infants will have their body composition assessed by deuterium labelled water at six months. Data on health, weaning diets and bowel function are also collected at each visit.
Ages Eligible for Study: | up to 10 Days |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |||||
MRC Childhood Nutrition Research Centre, Inst of Child Health | |||||
London, United Kingdom, WC1N 1EH | |||||
Maternity Hospital, Glasgow Royal Infirmary | |||||
Glasgow, United Kingdom, G4 ONA | |||||
Maternity Unit, Southern General Hospital, 1345 Govan Road | |||||
Glasgow, United Kingdom, G51 4TF | |||||
Maternity Unit, Royal Alexandra Hospital, Corsebar Road | |||||
Paisley, United Kingdom, PA2 9PN | |||||
The Queen Mother's Hospital, Yorkhill | |||||
Glasgow, United Kingdom, G3 8SJ | |||||
United Kingdom, Lanrkshire | |||||
Neonatal Unit, Wishaw Hospital, 50 Netherton St | |||||
Wishaw, Lanrkshire, United Kingdom, ML2 ODP |
Institute of Child Health |
Principal Investigator: | Atul Singhal | Institute of Child Health |
Study ID Numbers: | 99/2/109 |
First Received: | August 24, 2005 |
Last Updated: | November 4, 2005 |
ClinicalTrials.gov Identifier: | NCT00134771 |
Health Authority: | United Kingdom: Research Ethics Committee |
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