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

Women and Infants Hospital of Rhode Island168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

168

Conditions

Prematurity

Interventions

Amino acidsDRUG

Eligibility

Sex: ALLMax age: 18 Hours

Medical Language ↔ Plain English

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

Locations (1)

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Number of Participants With Weight<10th Percentile for Age

Time frame: 36 weeks post-conceptual age

Number of Participants With Length <10th Percentile for Age

Time frame: 36 weeks post-conceptual age

Number of Participants With Head Circumference <10th Percentile for Age

Time frame: 36 weeks post-conceptual age

Cognitive Development Score

Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.

Time frame: 18-22 months corrected gestational age

Secondary Outcomes

Serum Bicarbonate

Time frame: Day of life 1, 2, 3, 5 and 7

Serum Creatinine

Time frame: Day of life 1, 2, 3, 5 and 7

Serum Blood Urea Nitrogen

Time frame: Day of life 1, 2, 3, 5 and 7

Data from ClinicalTrials.gov

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