Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

November 4, 2005 updated by: Institute of Child Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G3 8SJ
        • The Queen Mother's Hospital, Yorkhill
      • Glasgow, United Kingdom, G4 ONA
        • Maternity Hospital, Glasgow Royal Infirmary
      • Glasgow, United Kingdom, G51 4TF
        • Maternity Unit, Southern General Hospital, 1345 Govan Road
      • London, United Kingdom, WC1N 1EH
        • MRC Childhood Nutrition Research Centre, Inst of Child Health
      • Paisley, United Kingdom, PA2 9PN
        • Maternity Unit, Royal Alexandra Hospital, Corsebar Road
    • Lanrkshire
      • Wishaw, Lanrkshire, United Kingdom, ML2 ODP
        • Neonatal Unit, Wishaw Hospital, 50 Netherton St

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Weight, length, head circumference at 6 months

Secondary Outcome Measures

Outcome Measure
Body composition at 6 months
Blood pressure at six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Child Health

Investigators

  • Principal Investigator: Atul Singhal, Institute of Child Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion

December 7, 2022

Study Completion

June 1, 2003

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

November 7, 2005

Last Update Submitted That Met QC Criteria

November 4, 2005

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99/2/109

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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