MINT- Melatonin Neuroprotection Trial Study -Ver 1

• Research type

  Research Study

• Full title

  Melatonin As A Novel Neuroprotectant In Preterm Infants-Trial Study

• IRAS ID

  1119

• Contact name

  David Edwards

• Sponsor organisation

  Imperial College, London

• Eudract number

  2008-004740-36

• ISRCTN Number

  not issued

• Research summary

  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. The aim of the study is 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.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. 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 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.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/0839

• Date of REC Opinion

  4 Aug 2011

• REC opinion

  Further Information Favourable Opinion