Amino Acid and Acylcarnitine Profiles in Premature Neonates
Information source: Pediatrix Medical Group
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prematurity; Neonatal Screening; Parenteral Nutrition
Phase: N/A
Status: Recruiting
Sponsored by: Pediatrix Medical Group Official(s) and/or principal investigator(s):
Reese Clark, MD, Principal Investigator, Affiliation: Pediatrix Medical Group, Inc.
Overall contact:
Amy Kelleher, MSHS, Phone: 800-243-3839, Ext: 5026, Email: amy_kelleher@pediatrix.com
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)
Clinical Details
Official title: How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates
Study design: Cohort, 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.
Eligibility
Minimum age: 23 Weeks.
Maximum age: 31 Weeks.
Gender(s): Both.
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
Locations and Contacts
Amy Kelleher, MSHS, Phone: 800-243-3839, Ext: 5026, Email: amy_kelleher@pediatrix.com
Memorial Hospital South Bend, South Bend, Indiana 46601, United States; Recruiting
Vitaliy Soloveychik, MD, Sub-Investigator
Robert White, MD, Principal Investigator
McLeod Regional Medical Center, Florence, South Carolina 29506, United States; Recruiting
Joseph Harlan, MD, Principal Investigator
Additional Information
Starting date: April 2009
Ending date: June 2010
Last updated: June 1, 2009
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