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Clinical Trials/NCT00134771
NCT00134771
Completed
N/A

Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

Institute of Child Health6 sites in 1 countryFebruary 2001

Overview

Phase
N/A
Intervention
Not specified
Conditions
Birth Weight
Sponsor
Institute of Child Health
Locations
6
Primary Endpoint
Weight, length, head circumference at 6 months
Status
Completed
Last Updated
20 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 2001
End Date
June 2003
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Infants who are formula fed from birth
  • Infants whose birthweights are less than 20th centile
  • Singleton births
  • Gestation \> 37 weeks
  • Infants free from major congenital disease

Exclusion Criteria

  • Infants who are breast-fed
  • Multiple births
  • Birthweight \> 20th centile
  • Infants with congenital disease
  • Gestation \< 37 weeks

Outcomes

Primary Outcomes

Weight, length, head circumference at 6 months

Secondary Outcomes

  • Blood pressure at six months
  • Body composition at 6 months

Study Sites (6)

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