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| Name | Class |
|---|---|
| Only For Children Pharmaceuticals | INDUSTRY |
| Cork University Hospital | OTHER |
| UMC Utrecht | OTHER |
| Helsinki University Central Hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bumetanide | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bumetanide | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal dose finding | The optimal dose is defined as achieving effective seizure reduction:
| 6 months |
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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
Exclusion Criteria:
Suspected or confirmed brain malformation, inborn error of metabolism,genetic syndrome, or major congenial malformation
Congenital (in utero) infection (TORCH).
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| Name | Affiliation | Role |
|---|---|---|
| Ronit Pressler, Dr | Great Ormond Street Hospital for Children NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cork University Maternity Hospital | Cork | Ireland | ||||
| Erasmus Universitair Medisch Centrum Rotterdam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25765333 | Derived | Pressler RM, Boylan GB, Marlow N, Blennow M, Chiron C, Cross JH, de Vries LS, Hallberg B, Hellstrom-Westas L, Jullien V, Livingstone V, Mangum B, Murphy B, Murray D, Pons G, Rennie J, Swarte R, Toet MC, Vanhatalo S, Zohar S; NEonatal seizure treatment with Medication Off-patent (NEMO) consortium. Bumetanide for the treatment of seizures in newborn babies with hypoxic ischaemic encephalopathy (NEMO): an open-label, dose finding, and feasibility phase 1/2 trial. Lancet Neurol. 2015 May;14(5):469-77. doi: 10.1016/S1474-4422(14)70303-5. Epub 2015 Mar 10. |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002034 | Bumetanide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062368 | meta-Aminobenzoates |
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| OTHER |
| Hôpital Necker-Enfants Malades | OTHER |
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| Karolinska University Hospital | OTHER |
| University College London Hospitals | OTHER |
| Uppsala University Hospital | OTHER |
| Erasmus Medical Center | OTHER |
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| Rotterdam |
| Netherlands |
| University Medical Centre Utrecht | Utrecht | 3508 AB | Netherlands |
| Karolinska Institutet and University Hospital | Stockholm | Sweden |
| Uppsala University Hospital | Uppsala | Sweden |
| Leeds General Infirmary | Leeds | United Kingdom |
| University College London Hospitals NHS Foundation Trust | London | United Kingdom |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |