Amino Acid and Acylcarnitine Profiles in Premature Neonates

Completed

• Conditions: Prematurity; Neonatal Screening; Parenteral Nutrition

• Registration Number: NCT00865150
• Lead Sponsor: Pediatrix

Brief Summary

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)

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 Timeline

• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Study Start: 2009-04
• Primary Completion: 2011-08
• Status Verified: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-28
• Last Update Posted: 2012-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	42 Days of Life

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Memorial Hospital South Bend; 🇺🇸 South Bend, Indiana, United States

McLeod Regional Medical Center; 🇺🇸 Florence, South Carolina, United States