Liquid Preterm Formula Versus Powdered Human Milk Fortifier in VLBW Infants

• Sponsor: University of Oklahoma (Other)
• Overall Status: Completed
• CT.gov ID: NCT00760942
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 3.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Very Low Birth Weight	Dietary Supplement: Similac special care 30; Dietary Supplement: Similac human milk fortifier	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The primary outcome will be weight gain in g/kg/d over the observation period. Body weight will be measured daily. [2 - 6 weeks]

Secondary Outcome Measures

1. Hospital stay and feeding intolerance [2-6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 10 Weeks
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oklahoma
• ClinicalTrials.gov Identifier: NCT00760942
• Other Study ID Numbers: 14132
• First Posted: Sep 26, 2008
• Last Update Posted: Dec 10, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by University of Oklahoma: Low birth weight; neonates; premature infants; nutrition; human milk fortification; Infant
• Additional relevant MeSH terms: Birth Weight

Study Results

No Results Posted as of Dec 10, 2013