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OpenTrials
Completed

NCT Number: NCT01609868

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

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.

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Key information

Conditions

Problem With Growth of an Infant

Age range

Up to 40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alegent Bergan Hospital

Omaha, Nebraska, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Infants receiving formula

Treatment and study plan

Powder protein modular

Dietary Supplement

Infants will receive powder protein modular to achieve 4 grm/kg/day

Liquid protein modular

Dietary Supplement

Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day

Primary outcomes

  1. Growth in premature infants (percentile ranking at 36 weeks CGA)

    Time frame: birth to 36 weeks

Secondary outcomes

  1. GI tolerance

    Time frame: birth to 36 weeks

    abdominal distention, feeding tolerance

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Alegent Health Bergan Mercy Medical Center

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 1, 2012
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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