NEMO1:NEonatal Seizure Using Medication Off-patent

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.

Conditions

• Neonatal Seizures

Interventions

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).

Sponsors & Collaborators

• Only For Children Pharmaceuticals

  collaborator INDUSTRY

• Cork University Hospital

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• Uppsala University Hospital

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  lead OTHER

Principal Investigators

• Ronit Pressler, Dr · Great Ormond Street Hospital for Children NHS Foundation Trust

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• Ireland
• Netherlands
• Sweden
• United Kingdom

Study Locations