Back to resultsLiquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
Primary Purpose
Infant, Very Low Birth Weight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Similac special care 30
Similac human milk fortifier
Sponsored by
About this trial
This is an interventional supportive care trial for Infant, Very Low Birth Weight focused on measuring Low birth weight, neonates, premature infants, nutrition, human milk fortification, Infant
Eligibility Criteria
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.
Sites / Locations
- Neonatal Intensive Care Unit/Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Liquid human milk fortifier
Powdered human milk fortifier
Outcomes
Primary Outcome Measures
The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily.
Secondary Outcome Measures
Hospital stay and feeding intolerance
Full Information
NCT ID
NCT00760942
First Posted
September 24, 2008
Last Updated
December 9, 2013
Sponsor
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT00760942
Brief Title
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
Official Title
Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Very Low Birth Weight
Keywords
Low birth weight, neonates, premature infants, nutrition, human milk fortification, Infant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Liquid human milk fortifier
Arm Title
2
Arm Type
Active Comparator
Arm Description
Powdered human milk fortifier
Intervention Type
Dietary Supplement
Intervention Name(s)
Similac special care 30
Intervention Description
Liquid pre-term formula 30Kcals/oz. used as human milk fortifier.
Intervention Type
Dietary Supplement
Intervention Name(s)
Similac human milk fortifier
Intervention Description
Powdered human milk fortifier.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Hospital stay and feeding intolerance
Time Frame
2-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Willeitner, M.D.
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal Intensive Care Unit/Children's Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants
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