Trial of Nutritional Supplementation in Infants Born Small for Gestational Age

Study Overview
=================
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.

Conditions
-----------------
Birth Weight

Intervention / Treatment
-----------------
* Drug: Nutrient enriched infant formula


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 10 Days

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nutrient enriched infant formula|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight, length, head circumference at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition at 6 months |  |  | 
| Blood pressure at six months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Singletons, Infants whose birthweight is less than the 20th centile for gestational age (UK standards), Infants who are formula fed from birth, Infants free from major congenital disease