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

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Drug: Amino acids

• Registration Number: NCT01860573
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2013-03
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-20
• Study First Posted: 2013-05-22
• Results First Submitted: 2016-11-01
• Study Completion: 2016-12
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-23
• Last Update Submitted: 2017-02-23
• Results First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard amino acids	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
High amino acids	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Weight<10th Percentile for Age	36 weeks post-conceptual age
Number of Participants With Length <10th Percentile for Age	36 weeks post-conceptual age
Number of Participants With Head Circumference <10th Percentile for Age	36 weeks post-conceptual age
Cognitive Development Score	18-22 months corrected gestational age	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.

Secondary Outcome Measures

Name	Time	Method
Serum Creatinine	Day of life 1, 2, 3, 5 and 7
Serum Blood Urea Nitrogen	Day of life 1, 2, 3, 5 and 7
Serum Bicarbonate	Day of life 1, 2, 3, 5 and 7

Trial Locations

Locations (1)

Women & Infants Hospital of Rhode Island; 🇺🇸 Providence, Rhode Island, United States