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NEMO1:NEonatal Seizure Using Medication Off-patent

Information source: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neonatal Seizures

Intervention: Bumetanide (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Great Ormond Street Hospital for Children NHS Foundation Trust

Official(s) and/or principal investigator(s):
Ronit Pressler, Dr, Principal Investigator, Affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust


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.

Clinical Details

Official title: NEMO1: An Open Label Exploratory Dose Finding and Pharmacokinetic Clinical Trial of Bumetanide for the Treatment of Neonatal Seizure Using Medication Off-patent

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Optimal dose finding


Minimum age: N/A. Maximum age: 48 Hours. Gender(s): Both.


Inclusion Criteria:-

- Male or female term baby with gestational age of 37-43 weeks and postnatal age <48


- One or more of the following:

- APGAR score < 5 at 5 mins.

- Umbilical cord or first arterial blood sample pH < 7. 1 or base deficit >16 mmol/L.

- Postnatal resuscitation still required 10 minutes after birth

- Clinically evolving encephalopathy

- Received one dose of standard anticonvulsive therapy (phenobarbitone,20mg/kg)

for clinical or electrographic seizures.

- EEG: equal to or more than 3 min cumulative seizures, or 2 or more seizures of

>30 sec duration over 2 hr period within first 48 hr of life

- Written informed consent of parent or guardian.

- EEG monitoring has commenced within the first 48 hours of birth.

Exclusion Criteria:

- Suspected or confirmed brain malformation, inborn error of metabolism,genetic

syndrome, or major congenial malformation

- Congenital (in utero) infection (TORCH).

- Babies who have received diuretics such as furosemide or bumetanide in routine

clinical management within the last 24 hours.

- Total serum bilirubin > 15 mg/dl (255 micromol/l) at inclusion.

- On any other anticonvulsive medication other than phenobarbitone or bolus of

midazolam / pentobarbitone for intubation.

- Anuria/renal failure defined as serum creatinine > 200 micromol/l.

- Severe electrolyte depletion (Na <120 mmol/L, K <3. 0 mmol/L)

Locations and Contacts

Cork University Maternity Hospital, Cork, Ireland

Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands

University Medical Centre Utrecht, Utrecht 3508 AB, Netherlands

Karolinska Institutet and University Hospital, Stockholm, Sweden

Uppsala University Hospital, Uppsala, Sweden

Leeds General Infirmary, Leeds, United Kingdom

University College London Hospitals NHS Foundation Trust, London, United Kingdom

Additional Information

Study web site

Starting date: August 2011
Last updated: June 19, 2013

Page last updated: August 23, 2015

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