Clinical trial NCT00134771: Trial of Nutritional Supplementation in Infants Born Small for Gestational Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2005-08-25
Sex: ALL
Minimum age (years): 0
Maximum age (years): 10
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.

Eligibility 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

Primary outcomes:
measure: Weight, length, head circumference at 6 months
Secondary outcomes:
measure: Body composition at 6 months
measure: Blood pressure at six months
Other outcomes:
Locations:
city: Wishaw
country: United Kingdom
facility: Neonatal Unit, Wishaw Hospital, 50 Netherton St
state: Lanrkshire
city: Glasgow
country: United Kingdom
facility: The Queen Mother's Hospital, Yorkhill
city: Glasgow
country: United Kingdom
facility: Maternity Hospital, Glasgow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Maternity Unit, Southern General Hospital, 1345 Govan Road
city: London
country: United Kingdom
facility: MRC Childhood Nutrition Research Centre, Inst of Child Health
city: Paisley
country: United Kingdom
facility: Maternity Unit, Royal Alexandra Hospital, Corsebar Road
Study officials:
affiliation: Institute of Child Health
name: Atul Singhal
role: PRINCIPAL_INVESTIGATOR
References: