Status:
COMPLETED
NEMO1:NEonatal Seizure Using Medication Off-patent
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborating Sponsors:
Only For Children Pharmaceuticals
Cork University Hospital
Conditions:
Neonatal Seizures
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE1
PHASE2
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 bum...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01434225
Start Date
August 1 2011
End Date
June 1 2013
Last Update
September 14 2015
Active Locations (7)
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1
Cork University Maternity Hospital
Cork, Ireland
2
Erasmus Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
3
University Medical Centre Utrecht
Utrecht, Netherlands, 3508 AB
4
Karolinska Institutet and University Hospital
Stockholm, Sweden