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Amino Acid and Acylcarnitine Profiles in Premature Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00865150
Recruitment Status : Completed
First Posted : March 19, 2009
Last Update Posted : March 1, 2012
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

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)

Condition or disease
Prematurity Neonatal Screening Parenteral Nutrition

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.

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Study Type : Observational
Actual Enrollment : 1003 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Illness and Nutritional Support Influence Amino Acid and Acylcarnitine Profiles in Premature Neonates
Study Start Date : April 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 31 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00865150

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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
Mednax Center for Research, Education, Quality and Safety
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Principal Investigator: Reese Clark, MD Pediatrix Medical Group, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mednax Center for Research, Education, Quality and Safety Identifier: NCT00865150    
Other Study ID Numbers: PDX-001-08
First Posted: March 19, 2009    Key Record Dates
Last Update Posted: March 1, 2012
Last Verified: February 2012
Keywords provided by Mednax Center for Research, Education, Quality and Safety:
Neonatal screening
Parenteral nutrition
Amino acids
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications