Dose Comparison of Amino Acids on Growth in Premature Neonates
Condition: Malnutrition
MeSH terms: Premature Birth; Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    


Intervention name(s): Parenteral Nutrition
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Premature neonate; Parenteral nutrition; Growth; Amino Acids; Nutrition