Dose Comparison of Amino Acids on Growth in Premature Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120926
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : September 28, 2006
Information provided by:
Mednax Center for Research, Education, Quality and Safety

July 11, 2005
July 19, 2005
September 28, 2006
August 2005
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The primary outcome is growth velocity for first 28 days of life calculated as: weight gain, head circumference, length
Same as current
Complete list of historical versions of study NCT00120926 on Archive Site
Secondary outcomes include serum amino acid profiles measured on: day 7 of life, day 28 of life
Same as current
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Dose Comparison of Amino Acids on Growth in Premature Neonates
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.

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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: Parenteral Nutrition
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2006
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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
Sexes Eligible for Study: All
up to 48 Hours   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Mednax Center for Research, Education, Quality and Safety
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Principal Investigator: Reese Clark, MD Pediatrix Medical Group, Inc.
Mednax Center for Research, Education, Quality and Safety
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP