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

Problem With Growth of an Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609868
• Other study ID #: 12-16432
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: January 29, 2018
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2018
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Infants receiving formula

Related Conditions & MeSH terms

• Problem With Growth of an Infant

Intervention

Dietary Supplement:
• Powder protein modular
Infants will receive powder protein modular to achieve 4 grm/kg/day
• Liquid protein modular
Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day

Locations

Country	Name	City	State
United States	Alegent Bergan Hospital	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Alegent Health Bergan Mercy Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth in premature infants (percentile ranking at 36 weeks CGA)		birth to 36 weeks
Secondary	GI tolerance	abdominal distention, feeding tolerance	birth to 36 weeks