Status:
COMPLETED
Effects of Parenteral L-carnitine Supplementation in Premature Neonates
Lead Sponsor:
University Hospital, Tours
Conditions:
Complication of Prematurity
Eligibility:
All Genders
Up to 28 years
Phase:
NA
Brief Summary
Background: Carnitine is the essential cofactor for various enzyme activities of human metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain fatty acids as acylcarni...
Detailed Description
Background: Carnitine is the essential cofactor for various enzyme activities of human metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain fatty acids as acylcarni...
Eligibility Criteria
Inclusion
- Premature newborn admitted in Intensive Care Unit,
- Gestational age minor or equal than 28 weeks and 6 days,
- Needing prolonged parenteral nutrition through a central intravenous catheter,
- Parenteral nutrition started before 6 days of life,
- Both parents (or legal tutor) gave written informed consent for their children,
- Patient affiliated to "Sécurité Sociale" of his parents.
Exclusion
- Severe associated disorder, with a probable short-term death,
- Identified genetic disease,
- Polymalformative syndrome, or severe malformation (heart, brain, others…),
- Inborn error of metabolism,
- Probable transfer of the subject before 25 days of life in another hospital that do not collaborate to this study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00841295
Start Date
July 1 2008
End Date
July 1 2013
Last Update
October 22 2018
Active Locations (2)
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1
UH Porte Madeleine
Orléans, France
2
Hôpital Clocheville, University Hospital, Tours
Tours, France