Dose Comparison of Amino Acids on Growth in Premature Neonates

September 27, 2006 updated by: Mednax Center for Research, Education, Quality and Safety

Randomized Control Trial Evaluating the Effect of Two Different Doses of Amino Acids on Growth and Serum Amino Acids in Premature Neonates Admitted to the NICU

Malnutrition is a common problem in the neonatal intensive care unit. Recent studies indicate that prematurely born neonates commonly develop a severe nutritional deficit during the first weeks after birth, referred to as extrauterine growth restriction. Despite an increase in growth during the second month of hospitalization, many neonates are ultimately discharged home having grown inadequately. The early nutritional deficit affects weight gain as well as growth in length and head circumference.

Growth measurements such as weight, length, and head circumference, however, are macroscopic measures of nutritional status and underestimate the physiologic consequences of prolonged nutritional deprivation. Energy and micronutrient deficiencies alter growth at a cellular and tissue level before macroscopic measures are altered. In the brain, for instance, energy is required for cell division and neuronal growth, glial cell function, and myelination. Energy deprivation may consequently alter neuronal function and growth, resulting in adverse neurodevelopmental outcomes.

Immunocompetence also appears to be sensitive to the untoward effects of energy and nutritional deficiency. Malnourished neonates often exhibit immune deficiencies related to inadequate protein intake that compound an already immature immune system. Such immunodeficiency results in susceptibility to infectious agents that creates substantial morbidity and mortality to the course of intensive care for premature infants.

A recent study suggests that postnatal malnutrition and growth restriction are inevitable if current recommended dietary intakes are followed. Multicenter studies show that variation in dietary intake accounts for 45% of the variation in growth. Hence, efforts have focused on determining whether nutritional deficiency and the observed growth restriction of premature infants can be prevented through the use of more optimal nutritional intake. In addition, inadequate protein support may be a primary cause for growth failure.

Based on animal studies showing high in utero amino acid flux observed during the latter phase of gestation, Thureen et al have suggested the use of higher doses of amino acid supplementation in order to minimize growth restriction and improve outcomes of premature infants. However there are no large human trials that demonstrate that this approach promotes better growth or that it is safe. While small doses of amino acids may be inadequate to promote normal growth, high doses may lead to elevated serum amino acid levels and increase the occurrence of toxicity. Through the implementation of a multicenter, randomized trial and tandem mass spectrometry, the investigators propose to evaluate the effects of two distinct strategies of amino acid supplementation on serum amino acid profiles and growth of premature infants during the first 28 days of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 3

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
    • South Carolina
      • Florence, South Carolina, United States, 29506
        • McLeod Regional Medical Center

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

1 second to 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documentation of informed consent
  • Inborn
  • Gestational age between 23 weeks and 0/7 days and 29 weeks and 6/7 days
  • If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
  • No major anomalies
  • Ability to begin parenteral nutrition within the first 48 hours after birth

Exclusion Criteria:

  • Outborn
  • Gestational age < 23 weeks or >= 30 weeks
  • Any major congenital anomalies

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length

Secondary Outcome Measures

Outcome Measure
Secondary outcomes include serum amino acid profiles measured on: day 7 of life, day 28 of life

Collaborators and Investigators

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

Sponsor

Mednax Center for Research, Education, Quality and Safety

Investigators

  • Principal Investigator: Reese Clark, MD, Pediatrix Medical Group, Inc.

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

August 1, 2005

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

July 11, 2005

First Submitted That Met QC Criteria

July 18, 2005

First Posted (Estimate)

July 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 28, 2006

Last Update Submitted That Met QC Criteria

September 27, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDX05-001

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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