Amino Acid and Acylcarnitine Profiles in Premature Neonates - Full Text View

Sponsor:	Pediatrix Medical Group
Information provided by:	Pediatrix Medical Group
ClinicalTrials.gov Identifier:	NCT00865150

Purpose

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)

Condition
Prematurity Neonatal Screening Parenteral Nutrition

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates

Resource links provided by NLM:

MedlinePlus related topics: Newborn Screening Nutritional Support

Drug Information available for: Amino acids, branched-chain

U.S. FDA Resources

Further study details as provided by Pediatrix Medical Group:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1000
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	23 Weeks to 31 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Hospital

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865150

Contacts

Contact: Amy Kelleher, MSHS

800-243-3839 ext 5026

amy_kelleher@pediatrix.com

Locations

United States, Indiana
Memorial Hospital South Bend	Recruiting
South Bend, Indiana, United States, 46601
Sub-Investigator: Vitaliy Soloveychik, MD
Principal Investigator: Robert White, MD
United States, South Carolina
McLeod Regional Medical Center	Recruiting
Florence, South Carolina, United States, 29506
Principal Investigator: Joseph Harlan, MD

Sponsors and Collaborators

Pediatrix Medical Group

Investigators

Principal Investigator:

Reese Clark, MD

Pediatrix Medical Group, Inc.

More Information

No publications provided

Responsible Party:	Reese Clark, MD, Director of Research, Pediatrix Medical Group, Pediatrix Medical Group, Inc.
ClinicalTrials.gov Identifier:	NCT00865150 History of Changes
Other Study ID Numbers:	PDX-001-08
Study First Received:	March 18, 2009
Last Updated:	December 13, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Pediatrix Medical Group:

Prematurity
Neonatal screening
Parenteral nutrition
Amino acids
Acylcarnitine

ClinicalTrials.gov processed this record on February 09, 2012