Amino Acid and Acylcarnitine Profiles in Premature Neonates
Completed
Conditions studied: Prematurity, Neonatal Screening, Parenteral Nutrition
In brief
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)
Key facts
- Study ID
- NCT00865150
- Run by
- Pediatrix
- People needed
- 1003
- Starts
- 2009-04-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2012-03-01
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Memorial Hospital South Bend — South Bend, Indiana, United States
- McLeod Regional Medical Center — Florence, South Carolina, United States
Full record on ClinicalTrials.gov
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