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NCT00760942 Clinical Trial

Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

Infant, Very Low Birth Weight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00760942
Other study ID # 14132
Secondary ID
Status Completed
Phase N/A
First received September 24, 2008
Last updated December 9, 2013
Start date October 2008
Est. completion date September 2010

Study information
Verified date December 2013
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date September 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 10 Weeks
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Similac special care 30
Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.
• Similac human milk fortifier
Powdered human milk fortifier.

Locations
Country Name City State
United States Neonatal Intensive Care Unit/Children's Hospital Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily. 2 - 6 weeks No
Secondary Hospital stay and feeding intolerance 2-6 weeks No
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