NEMO1:NEonatal Seizure Using Medication Off-patent

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.

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Key information

Conditions

Neonatal Seizures Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 48 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cork University Maternity Hospital, Cork, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Bumetanide

Drug

Bumetanide - Standard Phenobarbital plus either 0.05 mg/kg,0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg of bumetanide as determined by the the dose escalation design Maximum dose allowed is 0.3mg/kg given up to 4 times at 12 hourly intervals (total of 1.2mg/kg).

Primary outcomes

Optimal dose finding

Time frame: 6 months
The optimal dose is defined as achieving effective seizure reduction:
- Reduction of electrographic seizure (measuresd by EEG) burden by >80% during the 3rd and 4th hour after the first bumetanide administration compared to a 2 hour epoch prior to Bumetanide administration.
- No need for rescue AED within 48 hours

Sponsors and collaborators

Lead sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Other

Collaborators

Cork University Hospital
Erasmus Medical Center
Helsinki University Central Hospital
Hôpital Necker-Enfants Malades
Karolinska University Hospital
Only For Children Pharmaceuticals
The Leeds Teaching Hospitals NHS Trust
UMC Utrecht
University College London Hospitals
Uppsala University Hospital

Registry information

Official study title

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

Acronym: NEMO1

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 14, 2011
Registry last updated: Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed