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ISRCTN
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ISRCTN01115788
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ClinicalTrials.gov identifier
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NCT00649961
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Public title
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MIND: Melatonin Neuroprotection Dosage Study
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Scientific title
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Melatonin as a novel neuroprotectant in preterm infants - Dosage study
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Acronym
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MIND
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Serial number at source
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4169; G0502100
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Hammersmith and Queen Charlottes Hospital Research Ethics Committee approved on the 23rd April 2008 (ref: 08/H0707/33)
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Study design
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Multicentre non-randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
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Participants - inclusion criteria
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1. Infants born at less than 30 weeks gestation, either sex
2. No major congenital malformation
3. No cystic periventricular leukomalacia (cPVL) or haemorrhagic parenchymal infarction (HPI) on cranial ultrasonography
4. Parental consent given
5. Can begin treatment within 24 hours of birth
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Participants - exclusion criteria
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1. Major congenital malformation
2. Cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography
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Anticipated start date
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18/05/2010
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Anticipated end date
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25/12/2010
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Status of trial
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Completed |
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Patient information material
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Can be found at http://www.imperial.nhs.uk/discoveryscanning/index.htm
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Target number of participants
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Planned sample size: 24; UK sample size: 24
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Interventions
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The proposed clinical trial is a single dose, open label, dose escalation pharmacokinetic study in preterm infants less than 31 weeks gestation to achieve adult peak blood concentrations of melatonin (200 - 250 pmol/L). The trial will be a multicentre study based in the Neonatal Intensive Care Units of United Kingdom. A single intravenous infusion of melatonin will be given to each infant maximum over 6 hours once in the first 7 days of life. The starting dose is 0.1 microgram/kg/hr which will be increased or decreased incrementally in subsequent groups of infants until the desired melatonin concentration is achieved. A maximum of 24 preterm babies less than 31 weeks gestation will be recruited in this study. Four blood samples (0.5 - 1 ml) will be collected at various time points of the intravenous infusion along with bag urine samples to evaluate the pharmacokinetics profile of melatonin. Patients will followed up as routine local neonatal protocol.
Follow-up length: 0 months
Study entry: registration only
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Primary outcome measure(s)
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Serum melatonin level 200 - 250 pmol/L, measured at 6 hours after infusion started.
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Secondary outcome measure(s)
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Pharmacokinetics profile of melatonin in preterm infants
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Sources of funding
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Medical Research Council (MRC) (UK) (ref: G0502100)
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Trial website
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Publications
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Contact name
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Prof
David
Edwards
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Address
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School of Medicine
Hammersmith Hospital
Du Cane Road
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City/town
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London
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Zip/Postcode
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W12 0HS
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Country
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United Kingdom
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Sponsor
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Imperial College London (UK)
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Address
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ICCH Building
59 North Wharf Road
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City/town
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London
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Zip/Postcode
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W2 1LA
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Country
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United Kingdom
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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24/06/2010
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Last edited
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24/06/2010
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Date ISRCTN assigned
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24/06/2010
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