Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

This study has been completed.
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00134771
First received: August 24, 2005
Last updated: November 4, 2005
Last verified: August 2005
  Purpose

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-Blind
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.

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134771

Locations
United Kingdom
Neonatal Unit, Wishaw Hospital, 50 Netherton St
Wishaw, Lanrkshire, United Kingdom, ML2 ODP
Maternity Hospital, Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 ONA
Maternity Unit, Southern General Hospital, 1345 Govan Road
Glasgow, United Kingdom, G51 4TF
The Queen Mother's Hospital, Yorkhill
Glasgow, United Kingdom, G3 8SJ
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
Investigators
Principal Investigator: Atul Singhal Institute of Child Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00134771     History of Changes
Other Study ID Numbers: 99/2/109
Study First Received: August 24, 2005
Last Updated: November 4, 2005
Health Authority: United Kingdom: Research Ethics Committee

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
Singletons
Infants free from major congenital disease

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014