EMO is an EU FP7 funded project that will be the largest multicentered European study of neonatal seizures and their treatment. The aim of the project is to develop a safe and effective antiepileptic drug (AED) regimen for newborn babies with seizures. Seizures are the most common neurological emergency in the neonatal period and require prompt diagnosis and treatment. The project will evaluate the safety and efficacy of bumetanide in combination with phenobarbitone for seizure control

Active, not recruiting

• Conditions: eonatal Seizures in Hypoxic Ischemic Encephalopathy; MedDRA version: 15.0Level: LLTClassification code 10061197Term: Neonatal seizuresSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2010-020797-41-IE
• Lead Sponsor: Only for Children Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-10
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Male or female term baby with gestational age of 37-43 weeks and postnatal age <48 hours
2. 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
3. Clinical evolving encephalopathy
4. Received one dose of standard anticonvulsive therapy (phenobarbitone, 20mg/kg) for clinical or electrographic seizures.
5. EEG: equal to or more than 3 min cumulative seizures, or 2 or more seizures of >30 sec duration over a 2 hr period within the first 48 hr of life and after administration of one standard (20mg/kg) dose of phenobarbitone
6. Written informed consent of parent or guardian.
7. EEG monitoring has commenced within the first 48 hours of birth
Are the trial subjects under 18? yes
Number of subjects for this age range: 49
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Suspected or confirmed brain malformation, inborn error of metabolism, genetic syndrome, or major congenial malformation
2. Congenital (in utero) infection (TORCH) if known.
3. Babies who have received diuretics such as furosemide or bumetanide in routine clinical management within the last 24 hours
4. On any other anticonvulsive medication other than phenobarbitone or or bolus of midazolam / pentobarbitone for intubation.
6. Severe electrolyte depletion (Na <120 mmol/L, K <3.0 mmol/L)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified