Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00760942
First received: September 24, 2008
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.

  Eligibility

Ages Eligible for Study:   up to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760942

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

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov 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
neonates
premature infants
nutrition
human milk fortification
Infant

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014