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Amino Acid and Acylcarnitine Profiles in Premature Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT00865150
First received: March 18, 2009
Last updated: February 28, 2012
Last verified: February 2012
  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:


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 ]

Enrollment: 1003
Study Start Date: April 2009
Study Completion Date: February 2012
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Indiana
Memorial Hospital South Bend
South Bend, Indiana, United States, 46601
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
Sponsors and Collaborators
Pediatrix Medical Group
Investigators
Principal Investigator: Reese Clark, MD Pediatrix Medical Group, Inc.
  More Information

No publications provided

Responsible Party: Pediatrix Medical Group
ClinicalTrials.gov Identifier: NCT00865150     History of Changes
Other Study ID Numbers: PDX-001-08
Study First Received: March 18, 2009
Last Updated: February 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pediatrix Medical Group:
Prematurity
Neonatal screening
Parenteral nutrition
Amino acids
Acylcarnitine

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on November 20, 2014