Melatonin as a novel neuroprotectant in preterm infants - trial study
| ISRCTN | ISRCTN15119574 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15119574 |
| Clinical Trials Information System (CTIS) | 2008-004740-36 |
| Protocol serial number | 8659 |
| Sponsor | Imperial College London (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 06/01/2012
- Registration date
- 06/01/2012
- Last edited
- 28/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Nazakat Merchant
Scientific
Scientific
Hammersmith Hospital
Du Cane Road
London
London
W12 0HS
United Kingdom
| nazakat.merchant@csc.mrc.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Melatonin as a novel neuroprotectant in preterm infants - trial study |
| Study acronym | MINT |
| Study objectives | Premature babies are at risk of brain injury. Brain injury may lead to long term complications ranging from learning disabilities to cerebral palsy. No drug has been shown to protect these vulnerable babies from brain injury after early delivery. Experimental studies suggest that melatonin may reduce the risk of brain injury. The unborn baby receives maternal melatonin but following premature delivery, prolonged melatonin deficiency is noted, which may be harmful. Aim: To prove that melatonin given daily for 7 days after birth may reduce the risk of brain injury following preterm birth. The information we obtain from this study will help decide whether melatonin is a promising treatment for preterm brain injury and would lead to further larger clinical trials to find out if it should be made available to other preterm babies in the future. |
| Ethics approval(s) | First MREC, 04/08/2011 ref: 11/LO/0839 |
| Health condition(s) or problem(s) studied | Brain injury in premature babies |
| Intervention | This study will be a randomised controlled trial of 60 preterm infants less than 31 weeks gestation. It will be a multicentre study involving Imperial College Healthcare NHS Trust (Queen Charlottes' and Chelsea Hospital and St Mary's Hospital), Medway Maritime NHS Trust and St Thomas' Hospital, London UK. Routine cranial Ultrasound Imaging prior to starting treatment in the first 48 hours. Following informed parental consent, infants will be randomised to treatment with melatonin or normal saline (placebo) as intravenous infusion over 2 hours daily for 7 days starting from less than 48 hours of age. Clinical signs will be monitored continuously to confirm safety. The main outcome of the study will be changes on Magnetic Resonance Imaging (MRI) studies performed at term corrected age. Blood and urine will be taken at the same time as routine tests if possible to look at the melatonin levels. Donor and maternal breast milk will also be collected. All babies will continue to receive standard intensive care treatment. Participation will not affect the baby's care or prolong the hospital stay. The following will be measured: 1. Blood samples will be collected for melatonin levels at various time points during the inpatient stay 2. Maximum trial related blood loss <3% of total blood volume 3. Magnetic resonance imaging, 45-60 min scaning 4. Maternal Milk 1-2ml collection - milk expressed by mothers are sent off to a laboratory for melatonin dosage analysis by the clinical and research team 5. Urine samples will be collected non-invasively in a urine collection bag or cotton wool over 23 hours depending on local care given to the preterm infants. |
| Intervention type | Drug |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Melatonin |
| Primary outcome measure(s) |
Preserved fractional anisotropy measured by Tract-Based Spatial Statistics (TBSS) on diffusion tensor MRI at term corrected age measured at end of study |
| Key secondary outcome measure(s) |
1. MR imaging at term corrected age measured at end of study |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Infants born less than 31 weeks gestation who are less than 48 hours old 2. Parental consent for participation has been given |
| Key exclusion criteria | 1. Those with major congenital malformation 2. Those with cystic periventricular leucomalacia (cPVL) 3. Those with haemorrhagic parenchymal infarcts (HPI) on cranial ultrasonography prior to enrolment |
| Date of first enrolment | 01/11/2011 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 28/05/2020 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/05/2020: Added clinicaltrialsregister.eu link to basic results (scientific).
19/05/2017: : No publications found, study status unverified
