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Amino Acid and Acylcarnitine Profiles in Premature Neonates

Information source: Mednax Center for Research, Education and Quality
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prematurity; Neonatal Screening; Parenteral Nutrition

Phase: N/A

Status: Completed

Sponsored by: Mednax Center for Research, Education and Quality

Official(s) and/or principal investigator(s):
Reese Clark, MD, Principal Investigator, Affiliation: Pediatrix Medical Group, Inc.


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


Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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)

Secondary outcome: Occurrence of any of the following: death, cholestatic liver disease, positive blood or CSF culture, NEC, IVH, or respiratory support at 36 weeks PMA.

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.


Minimum age: 23 Weeks. Maximum age: 31 Weeks. Gender(s): Both.


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

Locations and Contacts

Memorial Hospital South Bend, South Bend, Indiana 46601, United States

McLeod Regional Medical Center, Florence, South Carolina 29506, United States

Additional Information

Starting date: April 2009
Last updated: February 28, 2012

Page last updated: August 23, 2015

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