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Clinical Trials/NCT00760942
NCT00760942CompletedNot Applicable

Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants

University of Oklahoma1 site in 1 country84 target enrollmentStarted: October 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
84
Locations
1
Primary Endpoint
The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
1 Day to 10 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

1

Active Comparator

Liquid human milk fortifier

Intervention: Similac special care 30 (Dietary Supplement)

2

Active Comparator

Powdered human milk fortifier

Intervention: Similac human milk fortifier (Dietary Supplement)

Outcomes

Primary Outcomes

The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.

Time Frame: 2 - 6 weeks

Secondary Outcomes

  • Hospital stay and feeding intolerance(2-6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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