Additional identifiers
EudraCT number
2007-007156-33
ClinicalTrials.gov number
NCT00649961
Protocol/serial number
4169; G0502100
Study information
Scientific title
Melatonin as a novel neuroprotectant in preterm infants - Dosage study
Acronym
MIND
Study hypothesis
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.
Ethics approval
Hammersmith and Queen Charlottes Hospital Research Ethics Committee, 23/04/2008, ref: 08/H0707/33
Study design
Multicentre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Can be found at http://www.imperial.nhs.uk/discoveryscanning/index.htm
Condition
Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention
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
Intervention type
Drug
Phase
Phase II
Drug names
Melatonin
Primary outcome measure
Serum melatonin level 200 - 250 pmol/L, measured at 6 hours after infusion started.
Secondary outcome measures
Pharmacokinetics profile of melatonin in preterm infants
Overall trial start date
18/05/2010
Overall trial end date
25/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Planned sample size: 24; UK sample size: 24
Participant exclusion criteria
1. Major congenital malformation
2. Cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography
Recruitment start date
18/05/2010
Recruitment end date
25/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
ICCH Building
59 North Wharf Road
London
W2 1LA
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0502100)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
See https://clinicaltrials.gov/ct2/show/results/NCT00649961
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23432339
Publication citations
-
Results
Merchant NM, Azzopardi DV, Hawwa AF, McElnay JC, Middleton B, Arendt J, Arichi T, Gressens P, Edwards AD, Pharmacokinetics of melatonin in preterm infants., Br J Clin Pharmacol, 2013, 76, 5, 725-733, doi: 10.1111/bcp.12092.