SURF, Neurodevelopment, Growth Study in SGA Infants

Infant, Small for Gestational Age Clinical Trial

Official title: Neurodevelopment, Growth, and Metabolic Syndrome Biomarkers in Term Small-for-gestational-age Infants Fed Standard or Nutrient-enriched Formula

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine whether term SGA infants who are fed a nutrient-enriched pre-term formula will have a higher cognitive score, a more appropriate length-for-age Z-score (leading to a lower prevalence of Stunting) but higher blood pressure at 2 years of age compared to term SGA infants who are fed on a regular starter formula.

Clinical Trial Description

This is multi-sites, interventional, double-blinded, randomized, 2-arm parallel-group clinical trial. Two HM fed groups will be included as comparator group.

The primary objectives are:

1. To evaluate neurodevelopment at 2 years of age in term small-for-gestational age (SGA) infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each human milk (HM)-fed group.

2. To evaluate length-for-age Z-score at 2 years of age in term SGA infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each HM-fed group.

3. To evaluate systolic blood pressure at 2 years of age in term SGA infants fed standard formula or nutrient-enriched formula from 1 to 6 months of age and compare to each HM-fed group. ;

Related Conditions & MeSH terms

• Infant, Small for Gestational Age

• NCT number: NCT04360967
• Study type: Interventional
• Source: Nestlé
• Status: Withdrawn
• Phase: N/A
• Start date: March 31, 2017
• Completion date: June 2, 2017