Status:
COMPLETED
Amino Acid and Acylcarnitine Profiles in Premature Neonates
Lead Sponsor:
Pediatrix
Conditions:
Prematurity
Neonatal Screening
Eligibility:
All Genders
23-31 years
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 betw...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
1003 Patients enrolled
Trial Details
Trial ID
NCT00865150
Start Date
April 1 2009
End Date
February 1 2012
Last Update
March 1 2012
Active Locations (2)
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1
Memorial Hospital South Bend
South Bend, Indiana, United States, 46601
2
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506