NEMO1:NEonatal Seizure Using Medication Off-patent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Neonatal Seizures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bumetanide

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).

Group Type EXPERIMENTAL

Bumetanide

Intervention Type 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).

Interventions

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Bumetanide

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).

Intervention Type DRUG

Eligibility Criteria

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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)

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No