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

NCT ID: NCT01609868

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Problem With Growth of an Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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control

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

Group Type ACTIVE_COMPARATOR

Powder protein modular

Intervention Type DIETARY_SUPPLEMENT

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

experimental

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

Group Type EXPERIMENTAL

Liquid protein modular

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Powder protein modular

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

Intervention Type DIETARY_SUPPLEMENT

Liquid protein modular

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Infants receiving formula
Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alegent Health Bergan Mercy Medical Center

UNKNOWN

Sponsor Role collaborator

University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Corrine K. Hanson, PhD

IRB Administrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alegent Bergan Hospital

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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12-16432

Identifier Type: -

Identifier Source: org_study_id

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