Status:
COMPLETED
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
British Medical Research Council
Conditions:
Premature Birth
Brain Injury
Eligibility:
All Genders
23-31 years
Phase:
PHASE2
Brief Summary
Preterm babies are at risk of brain injury. Melatonin, a naturally occurring hormone, may reduce this risk. The unborn baby receives melatonin from the mother but following premature delivery there ma...
Detailed Description
PURPOSE OF THE STUDY AND OBJECTIVES The overall purpose is to investigate whether melatonin, on achieving adult maternal peak blood levels in preterm infants, will reduce brain injury and white matter...
Eligibility Criteria
Inclusion
- Infants born less than 31 weeks gestation who are less than 7 days old, after parental consent for participation will be included in the study.
Exclusion
- Those with major congenital malformation, or cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to enrolment will be excluded from the study.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00649961
Start Date
May 1 2010
End Date
February 1 2011
Last Update
August 20 2019
Active Locations (2)
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1
Royal Bolton Hospital
Bolton, United Kingdom
2
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS