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NCT00120926 · ClinicalTrials.gov registry record · Phase 3

Dose Comparison of Amino Acids on Growth in Premature Neonates

A Phase 3 study of Malnutrition, sponsored by Pediatrix.

Completed
Registry status
Phase 3
Development phase
150
Enrollment target
1
Study location

NCT00120926 is a Phase 3 study of Malnutrition that has completed, run by Pediatrix. The registered enrollment target is 150 participants, below the 380-participant average among 17 other Malnutrition trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00120926, a Phase 3 study of Malnutrition, has completed, sponsored by Pediatrix.

COMPLETED
Registry status
Phase 3
Development phase
150 participants
Enrollment target
1
Study location

Study 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

Conditions Studied

Interventions

  • DRUG Parenteral Nutrition

Study Locations (1)

South Carolina

  • McLeod Regional Medical Center - Florence

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2005-08
Est. Completion 2006-06
Phase Phase 3

Sponsor

Pediatrix

28 total trials

What the Registry Record Tells You About NCT00120926

The ClinicalTrials.gov registry entry for NCT00120926 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 17 other Malnutrition trials with a reported enrollment target (61% lower). The listed sponsor is Pediatrix, which has 28 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Malnutrition appearing as the primary indexed condition, and to 1 intervention - of which Parenteral Nutrition is the first listed.

NCT00120926 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.

Frequently Asked Questions

What is clinical trial NCT00120926 about?

NCT00120926 is a clinical study titled "Dose Comparison of Amino Acids on Growth in Premature Neonates". 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 seco...

What is the current status of trial NCT00120926?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2005-08. Estimated completion is 2006-06.

What conditions does trial NCT00120926 study?

This clinical trial studies the following conditions: Malnutrition.

What interventions are being tested in trial NCT00120926?

The interventions under investigation include: Parenteral Nutrition (DRUG).

Who is sponsoring clinical trial NCT00120926?

This trial is sponsored by Pediatrix, which has 28 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00120926 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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