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Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

This study has been completed.
Information provided by:
Institute of Child Health Identifier:
First received: August 24, 2005
Last updated: November 4, 2005
Last verified: August 2005
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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training

Resource links provided by NLM:

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • Weight, length, head circumference at 6 months

Secondary Outcome Measures:
  • Body composition at 6 months
  • Blood pressure at six months

Study Start Date: February 2001
Estimated Study Completion Date: June 2003
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.


Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00134771

United Kingdom
Neonatal Unit, Wishaw Hospital, 50 Netherton St
Wishaw, Lanrkshire, United Kingdom, ML2 ODP
The Queen Mother's Hospital, Yorkhill
Glasgow, United Kingdom, G3 8SJ
Maternity Hospital, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 ONA
Maternity Unit, Southern General Hospital, 1345 Govan Road
Glasgow, United Kingdom, G51 4TF
MRC Childhood Nutrition Research Centre, Inst of Child Health
London, United Kingdom, WC1N 1EH
Maternity Unit, Royal Alexandra Hospital, Corsebar Road
Paisley, United Kingdom, PA2 9PN
Sponsors and Collaborators
Institute of Child Health
Principal Investigator: Atul Singhal Institute of Child Health
  More Information Identifier: NCT00134771     History of Changes
Other Study ID Numbers: 99/2/109
Study First Received: August 24, 2005
Last Updated: November 4, 2005

Keywords provided by Institute of Child Health:
Infants whose birthweight is less than the 20th centile for gestational age (UK standards)
Infants who are formula fed from birth
Infants free from major congenital disease

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms processed this record on September 21, 2017