Amino Acid and Acylcarnitine Profiles in Premature Neonates

February 28, 2012 updated by: Pediatrix

How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates

Primary Hypotheses of the study include:

  • Metabolic profiles are influenced by gestational age, chronological age, type and degree of nutritional support and illness
  • Metabolic profiles differ between neonates who receive commercial formula and neonates who receive primarily human breast milk
  • Neonates who develop parenteral associated cholestasis have metabolic markers that identify at risk patients (high serum urea nitrogen, citrulline, histidine, methionine, and succinyl carnitine and low thyroxine, serine and glutamate)
  • Neonates that have hypothyroidism have abnormal metabolic profiles (low tyrosine levels)

Study Overview

Status

Completed

Conditions

Detailed Description

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. Aggressive administration of parenteral amino acids to improve protein accretion rates in very preterm neonates has been supported in the literature. Although tolerance of high dose amino acids has been described, researchers acknowledge that sensitive tests to monitor amino acid toxicity are not readily available in the clinical setting.

The goals of this study are:

  • To better define normal amino acid and acylcarnitine values and how they change in premature neonates
  • To measure the effect nutritional support has (human breastmilk vs. formula) on amino acid and acylcarnitines profiles
  • To measure the effect of illness (parenteral nutrition associated cholestasis) on amino acid and acylcarnitine profiles
  • To better define abnormal metabolic profiles (low tyrosine levels) in neonates that have hypothyroidism.

Study Type

Observational

Enrollment (Actual)

1003

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital South Bend
    • South Carolina
      • Florence, South Carolina, United States, 29506
        • McLeod Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospital

Description

Inclusion Criteria

  • Documentation of informed consent
  • Inborn
  • Less than or equal to twenty four (24) hours of age
  • Gestational age between twenty three (23) weeks and 0/7 days and thirty one (31) weeks and 0/7 days as per the best estimate by the neonatologist
  • If subject is transferred to another hospital, the ability to obtain follow-up data on outcomes
  • No known major anomalies (inborn error of metabolism, chromosomal abnormalities, cyanotic congenital heart disease, gastroschisis, omphalocele, diaphragmatic hernia or other major gastrointestinal anomalies, major neurological injury or anomaly, and multiple congenital anomalies)

Exclusion Criteria

  • Outborn (transferred for intensive care from another hospital)
  • Greater than twenty four (24) hours of age
  • Gestational age < 23 weeks or > 31 weeks
  • Any known major congenital anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Metabolic Profile - Serum amino acid, acylcarnitine and thyroxine levels. Day of birth, (first 24 hours), Day 7, (parenteral nutrition effect), Day 28, (enteral nutrition effect), Day 42, or discharge (established enteral feeding and growth)
Time Frame: 42 Days of Life
42 Days of Life

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of any of the following: death, cholestatic liver disease, positive blood or CSF culture, NEC, IVH, or respiratory support at 36 weeks PMA.
Time Frame: 42 Days of Life
42 Days of Life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Investigators

  • Principal Investigator: Reese Clark, MD, Pediatrix Medical Group, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 1, 2012

Last Update Submitted That Met QC Criteria

February 28, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDX-001-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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