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

Completed

• Conditions: Other Preterm Infants
• Interventions: Other: Preterm infant formula per standard of care

• Registration Number: NCT02073071
• Lead Sponsor: Abbott Nutrition

Brief 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.

Study Timeline

• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-26
• Study First Posted: 2014-02-27
• Study Start: 2014-05
• Primary Completion: 2015-09
• Status Verified: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-25
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm/low birth weight infants	Preterm infant formula per standard of care	Preterm infant formula per standard of care

Primary Outcome Measures

Name	Time	Method
Weight	Change from first feeding to discharge (up to ~8 weeks)

Secondary Outcome Measures

Name	Time	Method
Length	Change from first feeding to discharge (up to ~8 weeks)
Head Circumference	Change from first feeding to discharge (up to ~8 weeks)
Hospitalization Length of Stay	Time from Birth to discharge (up to ~8 weeks)
Gastrointestinal Tolerance	From first feeding to discharge (up to ~8 weeks)	vomiting, abdominal distension, gastric residuals, stool abnormalities, necrotizing enterocolitis
Catch Up Growth	From discharge to 9 months corrected age	From discharge to the time point that infant's weight \>or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.

Trial Locations

Locations (10)

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

Hunan Children's Hospital; 🇨🇳 Changsha, Hunan, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Women's Hospital School Of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Children's Hospital of Shanghai; 🇨🇳 Shanghai, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China

Children's hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

Peking University First Hospital; 🇨🇳 Beijing, China