Birth Weight Clinical Trial
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training
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