NCT02073071

Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 139 (actual)
• Sponsor: Abbott Nutrition · Industry
• Sex: All
• Age: 21 Days
• Healthy volunteers: Not accepted

Summary

This is a two stage open-label, single-arm, multicenter and observational study.

Detailed description

Stage 1: In hospital, preterm/low birth weight infants less than or equal to 34 weeks gestational age at birth, birth weight of ≥ 1000g to \<1800g and conditions meeting the enrollment criteria will be fed formula with or without parenteral nutrition until discharge. Stage 2: Post-discharge, all infants with birth weight \< or =1500g will be followed on formula per standard of care and accepted standard of care including feeding until the infant's weight \>or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.

Conditions

• Other Preterm Infants

Interventions

Type	Name	Description
OTHER	Preterm infant formula per standard of care	Commercially available preterm infant formula

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2014-02-27
• Last updated: 2015-11-30

Locations

10 sites across 1 country: China