The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

Not Applicable

Completed

• Conditions: Problem With Growth of an Infant
• Interventions: Dietary Supplement: Powder protein modular; Dietary Supplement: Liquid protein modular

• Registration Number: NCT01609868
• Lead Sponsor: University of Nebraska

Brief Summary

The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-31
• Study Start: 2012-06
• Study First Posted: 2012-06-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Infants less than 2000 gms at birth, receiving maternal breast milk

Exclusion Criteria

• Infants receiving formula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control	Powder protein modular	infants in this arm will receive the current treatment that is standard of care for these infants, powder protein modular to achieve 4 gm/kg/day
experimental	Liquid protein modular	this group will receive a liquid protein modular that recently became commercially avaliable, to achieve the same protein of 4 grm/kg/day as the powder comparision group

Primary Outcome Measures

Name	Time	Method
Growth in premature infants (percentile ranking at 36 weeks CGA)	birth to 36 weeks

Secondary Outcome Measures

Name	Time	Method
GI tolerance	birth to 36 weeks	abdominal distention, feeding tolerance

Trial Locations

Locations (1)

Alegent Bergan Hospital; 🇺🇸 Omaha, Nebraska, United States