Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

December 9, 2013 updated by: University of Oklahoma

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Neonatal Intensive Care Unit/Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Liquid human milk fortifier
Dietary supplement: Similac special care 30
Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.
ACTIVE_COMPARATOR: 2
Powdered human milk fortifier
Dietary supplement: Similac human milk fortifier
Powdered human milk fortifier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 - 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital stay and feeding intolerance
Time Frame: 2-6 weeks
2-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: Andrea Willeitner, M.D., University of Oklahoma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

September 1, 2010

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (ESTIMATE)

September 26, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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