NCT00134771

Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Institute of Child Health · Academic / Other
• Sex: All
• Age: 0 Years – 10 Days
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Birth Weight

Interventions

Type	Name	Description
DRUG	Nutrient enriched infant formula

Timeline

• Start date: 2001-02-01
• Completion: 2003-06-01
• First posted: 2005-08-25
• Last updated: 2005-11-07

Locations

6 sites across 1 country: United Kingdom