Dose Comparison of Amino Acids on Growth in Premature Neonates

NCT00120926 | Completed Phase 3

• 1 other identifier: PDX05-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malnutrition

Keywords

Premature neonate; Parenteral nutrition; Growth; Amino Acids; Nutrition

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Parenteral Nutrition DRUG

Eligibility Criteria

• Age: 0 Years - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pediatrix: lead

Study Sites (1)

McLeod Regional Medical Center

Florence, South Carolina, 29506, United States

Location

Related Publications (5)

• Thureen PJ, Melara D, Fennessey PV, Hay WW Jr. Effect of low versus high intravenous amino acid intake on very low birth weight infants in the early neonatal period. Pediatr Res. 2003 Jan;53(1):24-32. doi: 10.1203/00006450-200301000-00008.

  PMID: 12508078 BACKGROUND

• Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

  PMID: 33006765 DERIVED

• Kelleher AS, Clark RH, Steinbach M, Chace DH, Spitzer AR; Pediatrix Amino-Acid Study Group. The influence of amino-acid supplementation, gestational age and time on thyroxine levels in premature neonates. J Perinatol. 2008 Apr;28(4):270-4. doi: 10.1038/jp.2008.5. Epub 2008 Feb 21.

  PMID: 18288119 DERIVED

• Steinbach M, Clark RH, Kelleher AS, Flores C, White R, Chace DH, Spitzer AR; Pediatrix Amino-Acid Study Group. Demographic and nutritional factors associated with prolonged cholestatic jaundice in the premature infant. J Perinatol. 2008 Feb;28(2):129-35. doi: 10.1038/sj.jp.7211889. Epub 2007 Dec 6.

  PMID: 18059467 DERIVED

• Clark RH, Chace DH, Spitzer AR; Pediatrix Amino Acid Study Group. Effects of two different doses of amino acid supplementation on growth and blood amino acid levels in premature neonates admitted to the neonatal intensive care unit: a randomized, controlled trial. Pediatrics. 2007 Dec;120(6):1286-96. doi: 10.1542/peds.2007-0545.

  PMID: 18055678 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Malnutrition; Premature Birth; Hyperphagia

Interventions

Parenteral Nutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Reese Clark, MD

  Pediatrix Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2005
• First Posted: July 19, 2005
• Study Start: August 1, 2005
• Study Completion: June 1, 2006
• Last Updated: September 28, 2006

Record last verified: 2006-09

Locations

US (1)