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NEMO1:NEonatal Seizure Using Medication Off-patent | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

NEMO1:NEonatal Seizure Using Medication Off-patent

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

NCT01434225•Great Ormond Street Hospital for Children NHS Foundation Trust

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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)

Locations (7)

Cork University Maternity Hospital

Cork, Ireland

Erasmus Universitair Medisch Centrum Rotterdam

Rotterdam, Netherlands

University Medical Centre Utrecht

Utrecht, 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

Key Dates

Start Date

August 1, 2011

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

September 14, 2015

Enrollment

ACTUAL participants

Conditions

Neonatal Seizures

Interventions

Bumetanide

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 14, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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