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

February 23, 2017 updated by: Joseph Bliss, Women and Infants Hospital of Rhode Island
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women & Infants Hospital of Rhode Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Amino acids
Other Names:
  • Premasol
Experimental: 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
Drug: Amino acids
Other Names:
  • Premasol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Serum Bicarbonate
Time Frame: Day of life 1, 2, 3, 5 and 7
Day of life 1, 2, 3, 5 and 7
Serum Creatinine
Time Frame: Day of life 1, 2, 3, 5 and 7
Day of life 1, 2, 3, 5 and 7
Serum Blood Urea Nitrogen
Time Frame: Day of life 1, 2, 3, 5 and 7
Day of life 1, 2, 3, 5 and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Investigators

  • Principal Investigator: Joseph M Bliss, MD, PhD, Women and Infants Hospital of Rhode Island

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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