NEMO1: NEonatal Seizure treatment with Medication Off-patent (v1.0)

• Research type

  Research Study

• Full title

  NEMO1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizures using Medication Off-patent.

• IRAS ID

  44284

• Contact name

  Ronit M Pressler

• Sponsor organisation

  Only for Children Pharmaceuticals

• Eudract number

  2010-020797-41

• ISRCTN Number

  Not Sent

• Research summary

  Seizures (or fits) are a common neurological emergency in newborn babies often caused by a lack of oxygen during birth. We know that many babies with seizures will have long-term problems such as cerebral palsy, epilepsy, hearing problems and leaning difficulties. The drugs we are currently using are not very effective and unfortunately there has been little research into the treatment of neonatal seizures compared to older children and adults. We propose a European wide multicentre study to test whether a well known diuretic (water medicine) can also help treating seizures in babies by changing an age-specific mechanism in nerve cells. The first drug which most doctors use to treat seizures in a newborn baby is called phenobarbitone which stops seizures in about half of babies treated. New research has found that if a drug called bumetanide is given at the same time as phenobarbitone, it may help phenobarbitone to work better. Bumetanide has been used as a diuretic for 30 years and is known to be well tolerated in adults, children and even very sick newborn babies. The NEMO-1 study aims to find the best dose of bumetanide for seizures in newborn babies using innovative methods. Parents of babies whose seizures do not stop after the first dose of phenobarbitone will be asked for their baby to take part in this study. Bumetanide will be given four times in total over 36 hours in addition to standard treatment. Seizures will be closely by monitored using EEG (brainwave) monitoring. EEG is a painless and safe test. Very small amounts of blood will also be taken during the study to calculate the best dose of bumetanide to give. Babies will be closely monitored for any possibly side effects such as loss of body salts.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/44

• Date of REC Opinion

  16 Jun 2010

• REC opinion

  Favourable Opinion