NCT01208493

Dietary Protein in the Very-low-birth-weight Infant

Dietary Protein in the Very-low-birth-weight Infant: Effects of the Level of Dietary Protein on Growth and Feeding Tolerance

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 1 Day – 10 Weeks
• Healthy volunteers: Accepted

Summary

In this randomized study The investigators aim to compare the growth of very-low-birth-weight (VLBW) infants fed either a high protein or a standard protein preterm infant formula. Babies will be fed the assigned formula between the time they achieve full enteral feeds and hospital discharge, for a minimum of 3 weeks. The weight gain (g/d) will be measured and compared between groups. Feeding tolerance, protein-energy status and body composition between the study groups will also be analysed. After discharge, babies will be fed a post-discharge preterm infant formula (PDF) between hospital discharge and 3 m corrected age.

Conditions

• Prematurity

Interventions

Type	Name	Description
OTHER	preterm infant formula with high protein levels	minimum 3 weeks feeding until hospital discharge
OTHER	preterm standard infant formula	minimum 3 weeks feeding until hospital discharge

Timeline

• Start date: 2007-09-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2010-09-24
• Last updated: 2015-03-26

Locations

4 sites across 4 countries: United States, Belgium, France, United Kingdom