Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia (NeoNATI)
| ISRCTN | ISRCTN62175998 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62175998 |
| ClinicalTrials.gov (NCT) | NCT01241019 |
| Clinical Trials Information System (CTIS) | 2010-018627-25 |
| Protocol serial number | 2010-018627-25 |
| Sponsor | A. Meyer University Childrens Hospital (Italy) |
| Funder | General Directorate for Health Law and Policy of Solidarity, Area Coordinating Health, Division of Research, Development and Labor Protection in the Region of Tuscany (Italy) - Regional Health Research Program 2009 |
- Submission date
- 26/11/2010
- Registration date
- 06/06/2011
- Last edited
- 11/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Luca Filippi
Scientific
Scientific
A. Meyer University Childrens Hospital
Neonatal Intensive Care Unit
Department of Perinatal Medicine
Viale Pieraccini, 24
Florence
I-50139
Italy
| Phone | +39 (0)55 566 2434 |
|---|---|
| l.filippi@meyer.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two-centre interventional pilot randomised controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia: a pilot study of the Neonatal Neuroprotection of Asphyxiated Tuscan Infants (NeoNATI) Network |
| Study acronym | NeoNATI |
| Study objectives | To determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy (HIE) potentiates the neuroprotective effect of treatment with hypothermia |
| Ethics approval(s) | Ethics Committee of Azienda Ospedaliero-Universitaria "A. Meyer" of Florence; approved on January 10, 2010 |
| Health condition(s) or problem(s) studied | Hypoxic Ischemic Encephalopathy (HIE) |
| Intervention | Newborns with moderate to severe hypoxic ischaemic encephalopathy at two centres in Florence and Pisa will be randomised to one of the following treatment arms: 1. Intervention group: Newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia wiil receive topiramate (TPM) 10 mg/kg once a day, administered with an orogastric tube as enteric-coated granules mixed with water on arrival in the NICU, when the cooling will be begun (T0), once a day for the first 3 days of life, for a total of 3 doses per patient. 2. Control group: Newborns with hypoxic ischemic encephalopathy will be treated only with mild hypothermia |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Topiramate |
| Primary outcome measure(s) | 1. Survival rate 2. General movements at 7-10 days and after 12 weeks of life 3. Neurological examination including: 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 3.2. Acoustic functions at 7-10 days, 6 months, 12 months and 18 months of life 3.3. Visual functions at 7-10 days, 6 months, 12 months and 18 months of life |
| Key secondary outcome measure(s) | 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) |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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) |
| Key exclusion criteria | 1. Congenital abnormalities 2. Congenital viral infections 3. Evidence of encephalopathy other than HIE |
| Date of first enrolment | 09/02/2010 |
| Date of final enrolment | 01/02/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
A. Meyer University Childrens Hospital
Florence
I-50139
Italy
I-50139
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2018 | 16/01/2019 | Yes | No |
| Protocol article | protocol | 05/09/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
11/04/2019: Internal review.
16/01/2019: Publication reference added
