Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134771
Status:
COMPLETED
Last Update Posted:
2005-11-07
First Post:
2005-08-24
Brief Title:
Trial of Nutritional Supplementation in Infants Born Small for Gestational Age
Sponsor:
Institute of Child Health
Organization:
Institute of Child Health
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None