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

ISRCTN	ISRCTN62175998
DOI	https://doi.org/10.1186/ISRCTN62175998
EudraCT/CTIS number	2010-018627-25
ClinicalTrials.gov number	NCT01241019
Secondary identifying numbers	2010-018627-25

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

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
Email	l.filippi@meyer.it

Study information

Study design	Two-centre interventional pilot randomised controlled study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient 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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Topiramate
Primary outcome measure	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
Secondary outcome measures	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)
Overall study start date	09/02/2010
Completion date	01/02/2012

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	60 participants from two centres in Florence and Pisa
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

Sponsor information

A. Meyer University Childrens Hospital (Italy)
Hospital/treatment centre

Azienda Ospedaliero-Universitaria A. Meyer
Neonatal Intensive Care Unit
Department of Perinatal Medicine
Viale Pieraccini, 24
Florence
I-50139
Italy

"ROR"	https://ror.org/01n2xwm51

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	05/09/2012		Yes	No
Results article	results	01/04/2018	16/01/2019	Yes	No

Editorial Notes

11/04/2019: Internal review.
16/01/2019: Publication reference added