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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014