Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2016-12-31

Brief Summary

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The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.

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Detailed Description

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Conditions

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Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Standard amino acids

Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day

Group Type ACTIVE_COMPARATOR

Amino acids

Intervention Type DRUG

High amino acids

Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth

Group Type EXPERIMENTAL

Amino acids

Intervention Type DRUG

Interventions

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Amino acids

Intervention Type DRUG

Other Intervention Names

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Premasol

Eligibility Criteria

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Inclusion Criteria

* birth weight 400 to 1250 grams
* 24 0/7 to 30 6/7 weeks gestational age

Exclusion Criteria

* chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth
* infants \>18 hours of age
* infants in extremis who are unlikely to survive past 72 hours

Maximum Eligible Age

18 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No