Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

Not Applicable

Completed

• Conditions: Infant, Very Low Birth Weight
• Interventions: Dietary Supplement: Similac human milk fortifier; Dietary Supplement: Similac special care 30

• Registration Number: NCT00760942
• Lead Sponsor: University of Oklahoma

Brief Summary

This study aims to compare the short-term effects on growth and feeding tolerance of a liquid high calorie formula added to human milk versus powdered human milk fortifier in small preterm infants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Study Start: 2008-10
• Primary Completion: 2010-03
• Study Completion: 2010-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Infants between 500 and 1499 grams of birthweight, receiving mother's milk.

Exclusion Criteria

• Infants with major congenital anomalies and previous history of gastrointestinal disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Similac human milk fortifier	Powdered human milk fortifier
1	Similac special care 30	Liquid human milk fortifier

Primary Outcome Measures

Name	Time	Method
The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.	2 - 6 weeks

Secondary Outcome Measures

Name	Time	Method
Hospital stay and feeding intolerance	2-6 weeks

Trial Locations

Locations (1)

Neonatal Intensive Care Unit/Children's Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States