Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia (NeoNATI)

Not Applicable

Completed

• Conditions: Hypoxic Ischemic Encephalopathy (HIE); Neonatal Diseases; Other disturbances of cerebral status of newborn

• Registration Number: ISRCTN62175998
• Lead Sponsor: A. Meyer University Children?s Hospital (Italy)

Brief Summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22950861 2. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28274169 (added 16/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-06
• Study Completion: 2012-02-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Newborns with gestational age > 36 weeks and birth weigh > 1800 g with at least 1 of the following:
1.1. Apgar score < 5 at 10 minutes
1.2. Persisting need for resuscitation, including endotracheal intubation or mask ventilation 10 minutes after birth
1.3. Acidosis (pH <7.0, base deficit >-16 mmol/L in umbilical cord blood or arterial, venous or capillary blood) within 60 minutes from birth
2. Moderate to severe encephalopathy, consisting of altered state of consciousness (irritability, lethargy, stupor, or coma) and > 1 of the following signs:
2.1. Hypotonia
2.2. Abnormal reflexes, including oculomotor or pupil abnormalities
2.3. Absent or weak suck
2.4. Clinical seizures
3. Abnormal ambulatory electroencephalogram (aEEG)

Exclusion Criteria

1. Congenital abnormalities
2. Congenital viral infections
3. Evidence of encephalopathy other than HIE

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Survival rate<br> 2. General movements at 7-10 days and after 12 weeks of life<br> 3. Neurological examination including:<br> 3.1. Gross motor function at 7-10 days, 12 weeks, 6 months, 12 months, 18 months of life using Dubowitz neurological examination and Bayley test<br> 3.2. Acoustic functions at 7-10 days, 6 months, 12 months and 18 months of life<br> 3.3. Visual functions at 7-10 days, 6 months, 12 months and 18 months of life<br>

Secondary Outcome Measures

Name	Time	Method
Efficacy of treatment with topiramate for improving neuroradiological outcome at 3 and 12 months of life using cerebral Magnetic Resonance Imaging (MRI) (standard, with diffusion tensor imaging and with Spectroscopy)