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Completed Phase 3 Interventional

Dose Comparison of Amino Acids on Growth in Premature Neonates

ClinicalTrials.gov ID: NCT00120926

Public ClinicalTrials.gov record NCT00120926. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00120926
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pediatrix
Other
Enrollment
150 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
0 Years to 48 Hours
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2005
Primary completion
Not listed
Completion
May 31, 2006
Last update posted
Sep 27, 2006

2005 – 2006

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
McLeod Regional Medical Center Florence South Carolina 29506

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00120926, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 27, 2006 · Synced Sep 12, 2026

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