Melatonin as a novel neuroprotectant in preterm infants - trial study

ISRCTN	ISRCTN15119574
DOI	https://doi.org/10.1186/ISRCTN15119574
EudraCT/CTIS number	2008-004740-36
Secondary identifying numbers	8659

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

Hammersmith Hospital
Du Cane Road
London
London
W12 0HS
United Kingdom

Email	nazakat.merchant@csc.mrc.ac.uk

Study information

Study design	Randomised interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Melatonin
Primary outcome measure	Preserved fractional anisotropy measured by Tract-Based Spatial Statistics (TBSS) on diffusion tensor MRI at term corrected age measured at end of study
Secondary outcome measures	1. MR imaging at term corrected age measured at end of study 2. Pharmacokinetics of melatonin 3. Population pharmacokinetics of melatonin
Overall study start date	01/11/2011
Completion date	01/07/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	Planned Sample Size: 60; UK Sample Size: 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

England
United Kingdom

Study participating centre

Hammersmith Hospital

London
W12 0HS
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

School of Medicine
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom

Phone	+44 (0)20 7589 5111
Email	no@no
Website	http://www3.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
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			28/05/2020	No	No
HRA research summary			28/06/2023	No	No

Editorial Notes

28/05/2020: Added clinicaltrialsregister.eu link to basic results (scientific).
19/05/2017: : No publications found, study status unverified