NEMO1:NEonatal Seizure Using Medication Off-patent

Summary

NEMO is a multicentre pan European clinical trial with the aim to develop new treatment strategies for the treatment of neonatal seizures using the loop diuretic bumetanide. There is evidence that bumetanide improves GABAergic function of the current standard drug, phenobarbitone. Bumetanide has been used as a diuretic in term and preterm babies for around thirty years. This trial should confirm that Bumetanide in addition to standard treatment will result in better seizures control.

Timeline

Start

2011-08

Primary completion

2013-06

Completion

2013-06

Outcome

Missed primary endpoint

paper only two did not need rescue antiepileptic drugs (ie, met rescue criteria; one on 0·05 mg/kg and one on 0·3 mg/kg). PMID 25765333 ↗

paper Our findings suggest that bumetanide as an add-on to phenobarbital does not improve seizure control in newborn infants PMID 25765333 ↗

Publications

• Pressler RM, Boylan GB, Marlow N, Blennow M, Chiron C, Cross JH, de Vries LS, Hallberg B, Hellstrom-Westas L, Jullien V, Livingstone V, Mangum B, Murphy B, Murray D, Pons G, Rennie J, Swarte R, Toet MC, Vanhatalo S, Zohar S; NEonatal seizure treatment with Medication Off-patent (NEMO) consortium. Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO): an open-label, dose finding, and feasibility phase 1/2 trial. Lancet Neurol. 2015 May;14(5):469-77. doi: 10.1016/S1474-4422(14)70303-5. Epub 2015 Mar 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bumetanide	Small molecule	0.05 mg/kg	Intravenous
Subject	Bumetanide	Small molecule	0.1 mg/kg	Intravenous
Subject	Bumetanide	Small molecule	0.2 mg/kg	Intravenous
Subject	Bumetanide	Small molecule	0.3 mg/kg	Intravenous

Indications