MIND: Melatonin Neuroprotection Dosage Study
| ISRCTN | ISRCTN01115788 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01115788 |
| EudraCT/CTIS number | 2007-007156-33 |
| ClinicalTrials.gov number | NCT00649961 |
| Secondary identifying numbers | 4169; G0502100 |
- Submission date
- 24/06/2010
- Registration date
- 24/06/2010
- Last edited
- 22/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Edwards
Scientific
Scientific
School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
| Study design | Multicentre non-randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Can be found at http://www.imperial.nhs.uk/discoveryscanning/index.htm |
| Scientific title | Melatonin as a novel neuroprotectant in preterm infants - Dosage study |
| Study acronym | MIND |
| Study objectives | 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(s) | Hammersmith and Queen Charlottes Hospital Research Ethics Committee, 23/04/2008, ref: 08/H0707/33 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 18/05/2010 |
| Completion date | 25/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Planned sample size: 24; UK sample size: 24 |
| Key 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 |
| Key exclusion criteria | 1. Major congenital malformation 2. Cystic periventricular leucomalacia (cPVL) or haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography |
| Date of first enrolment | 18/05/2010 |
| Date of final enrolment | 25/12/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
ICCH Building
59 North Wharf Road
London
W2 1LA
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) (ref: G0502100)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/11/2013 | Yes | No |
Editorial Notes
22/03/2016: added link to results - basic reporting.
