Dr Nazakat Merchant
Du Cane Road
Melatonin as a novel neuroprotectant in preterm infants - trial study
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.
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.
First MREC, 04/08/2011 ref: 11/LO/0839
Randomised interventional trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Brain injury in premature babies
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.
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 trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Medical Research Council (MRC) (UK)
Funding Body Type
Funding Body Subtype
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)