Skip to content

Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00134771
Enrollment
Unknown
Registered
2005-08-25
Start date
2001-02-28
Completion date
2003-06-30
Last updated
2005-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Weight

Keywords

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

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.

Interventions

DRUGNutrient enriched infant formula

Sponsors

Institute of Child Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
0 Years to 10 Days

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

Design outcomes

Primary

MeasureTime frame
Weight, length, head circumference at 6 months

Secondary

MeasureTime frame
Body composition at 6 months
Blood pressure at six months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026