NCT00649961|CompletedPhase 2Results
Melatonin As A Novel Neuroprotectant In Preterm Infants- Dosage Study
MIND
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
18
1 country
2
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)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 maybe a period of prolonged melatonin deficiency. This deficiency may be harmful because studies suggest that melatonin is important in protecting the brain and reducing the risk of brain injury after preterm birth. The purpose of this study is to find the ideal dose of melatonin to give to preterm babies. We intend to study a total of 24 babies less than 31 weeks gestation and who are less than 7 days old.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 27, 2008
Actual (reported)April 1, 2008
Actual (reported)May 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 2011
Actual (reported)February 2011
Actual (reported)February 28, 2014
Actual (reported)To Find the Dose of Melatonin Required to Achieve Physiological Blood Levels in the Preterm Infants Similar to That of the Mother.
6 months
Infants born less than 31 weeks gestation who are less than 7 days old
A single intravenous infusion of melatonin will be given to each infant over 6 hours so that successive groups will receive increasing doses until the correct dose for age is found. Based on the pharmacokinetics and clearance of melatonin in adults an approximate dose has been calculated. The starting dose of melatonin will be 0.1 microgram/kg/hr to be given over 6 hours intravenously. The range of expected dose is 0.1-0.5 microgram/kg/hr.
Royal Bolton Hospital
Bolton, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Jan JE, Wasdell MB, Freeman RD, Bax M. Evidence supporting the use of melatonin in short gestation infants. J Pineal Res. 2007 Jan;42(1):22-7. doi: 10.1111/j.1600-079X.2006.00398.x.
Volpe JJ. Cerebral white matter injury of the premature infant-more common than you think. Pediatrics. 2003 Jul;112(1 Pt 1):176-80. doi: 10.1542/peds.112.1.176. No abstract available.
Wood NS, Marlow N, Costeloe K, Gibson AT, Wilkinson AR. Neurologic and developmental disability after extremely preterm birth. EPICure Study Group. N Engl J Med. 2000 Aug 10;343(6):378-84. doi: 10.1056/NEJM200008103430601.
David Edwards, FRCPCH
Imperial College London
Denis Azzopardi, FRCPCH
Imperial College London
Nazakat Merchant, MRCPCH
Imperial College London
18 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2008
First Posted
April 1, 2008
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Melatonin in Relapsing-Remitting Multiple Sclerosis Patients
Contact the study team to confirm eligibility.
Primary Completion
February 2011
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
August 20, 2019
Results First Posted
February 28, 2014
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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