Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

Birth Weight Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134771
• Other study ID #: 99/2/109
• Status: Completed
• Phase: N/A
• First received: August 24, 2005
• Last updated: November 4, 2005
• Start date: February 2001
• Est. completion date: June 2003

Study information

• Verified date: August 2005
• Source: Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2003
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Birth Weight

Intervention

Drug:
• Nutrient enriched infant formula

Locations

Country	Name	City	State
United Kingdom	Maternity Hospital, Glasgow Royal Infirmary	Glasgow
United Kingdom	Maternity Unit, Southern General Hospital, 1345 Govan Road	Glasgow
United Kingdom	The Queen Mother's Hospital, Yorkhill	Glasgow
United Kingdom	MRC Childhood Nutrition Research Centre, Inst of Child Health	London
United Kingdom	Maternity Unit, Royal Alexandra Hospital, Corsebar Road	Paisley
United Kingdom	Neonatal Unit, Wishaw Hospital, 50 Netherton St	Wishaw	Lanrkshire

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight, length, head circumference at 6 months
Secondary	Body composition at 6 months
Secondary	Blood pressure at six months