NCT04360967

SURF, Neurodevelopment, Growth Study in SGA Infants

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 1 Day – 44 Days
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Infant, Small for Gestational Age

Interventions

Type	Name	Description
OTHER	Standard Formula	Standard Formula
OTHER	Nutrient-enriched Formula	Nutrient-enriched Formula

Timeline

• Start date: 2017-03-31
• Primary completion: 2017-06-02
• Completion: 2017-06-02
• First posted: 2020-04-24
• Last updated: 2020-04-24