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

Women and Infants Hospital of Rhode Island

Status: Completed

Conditions: Prematurity

Treatments: Drug: Amino acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01860573

08-0089

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: Under 18 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups

Standard amino acids

Active Comparator group

Description:

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

Treatment:

Drug: Amino acids

High amino acids

Experimental group

Description:

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

Treatment:

Drug: Amino acids