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NEMO1:NEonatal Seizure Using Medication Off-patent (NEMO1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01434225
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 14, 2015
Sponsor:
Collaborators:
Only For Children Pharmaceuticals
Cork University Hospital
UMC Utrecht
Helsinki University Central Hospital
Hôpital Necker-Enfants Malades
The Leeds Teaching Hospitals NHS Trust
Karolinska University Hospital
University College London Hospitals
Uppsala University Hospital
Erasmus Medical Center
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Neonatal Seizures Drug: Bumetanide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Bumetanide

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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).
 Drug: 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434225


Locations
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Ireland
Cork University Maternity Hospital
Cork, Ireland
Netherlands
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
University Medical Centre Utrecht
Utrecht, Netherlands, 3508 AB
Sweden
Karolinska Institutet and University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Only For Children Pharmaceuticals
Cork University Hospital
UMC Utrecht
Helsinki University Central Hospital
Hôpital Necker-Enfants Malades
The Leeds Teaching Hospitals NHS Trust
Karolinska University Hospital
University College London Hospitals
Uppsala University Hospital
Erasmus Medical Center
Investigators
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Principal Investigator: Ronit Pressler, Dr Great Ormond Street Hospital for Children NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01434225    
Other Study ID Numbers: 08NR26
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: September 2015
Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
Neonatal seizures
Hypoxic Ischemic Encephalopathy
Electroencephalography
Bumetanide
Additional relevant MeSH terms:
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Seizures
Neurologic Manifestations
Nervous System Diseases
Bumetanide
Diuretics
 Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action