Dose Comparison of Amino Acids on Growth in Premature Neonates

This study has been completed.
Sponsor:
Information provided by:
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT00120926
First received: July 11, 2005
Last updated: September 27, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Malnutrition
Drug: Parenteral Nutrition
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pediatrix Medical Group:

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

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

Estimated Enrollment: 150
Study Start Date: August 2005
Estimated Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00120926

Locations
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
Sponsors and Collaborators
Pediatrix Medical Group
Investigators
Principal Investigator: Reese Clark, MD Pediatrix Medical Group, Inc.
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00120926     History of Changes
Other Study ID Numbers: PDX05-001
Study First Received: July 11, 2005
Last Updated: September 27, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Pediatrix Medical Group:
Premature neonate
Parenteral nutrition
Growth
Amino Acids
Nutrition

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on October 01, 2014