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Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

This study has been completed.
Information provided by (Responsible Party):
University of Oklahoma Identifier:
First received: September 24, 2008
Last updated: December 9, 2013
Last verified: December 2013

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.

Condition Intervention
Infant, Very Low Birth Weight
Dietary Supplement: Similac special care 30
Dietary Supplement: Similac human milk fortifier

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Randomized Study of a Liquid High-Calorie Preterm Formula Versus Powdered Human Milk Fortifier in Very-Low Birthweight Infants

Resource links provided by NLM:

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay and feeding intolerance [ Time Frame: 2-6 weeks ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   up to 10 Weeks
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00760942

United States, Oklahoma
Neonatal Intensive Care Unit/Children's Hospital
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Principal Investigator: Andrea Willeitner, M.D. University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma Identifier: NCT00760942     History of Changes
Other Study ID Numbers: 14132
Study First Received: September 24, 2008
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Low birth weight
premature infants
human milk fortification
Infant processed this record on March 03, 2015