Contact information
Type
Scientific
Primary contact
Dr Luca Filippi
ORCID ID
Contact details
A. Meyer University Childrens Hospital
Neonatal Intensive Care Unit
Department of Perinatal Medicine
Viale Pieraccini
24
Florence
I-50139
Italy
+39 (0)55 566 2434
l.filippi@meyer.it
Additional identifiers
EudraCT number
2010-018627-25
ClinicalTrials.gov number
NCT01241019
Protocol/serial number
2010-018627-25
Study information
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
Acronym
NeoNATI
Study hypothesis
To determine whether the administration of topiramate to newborns with hypoxic-ischemic encephalopathy (HIE) potentiates the neuroprotective effect of treatment with hypothermia
Ethics approval
Ethics Committee of Azienda Ospedaliero-Universitaria "A. Meyer" of Florence; approved on January 10, 2010
Study design
Two-centre interventional pilot randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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 names
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 trial start date
09/02/2010
Overall trial end date
01/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
60 participants from two centres in Florence and Pisa
Participant exclusion criteria
1. Congenital abnormalities
2. Congenital viral infections
3. Evidence of encephalopathy other than HIE
Recruitment start date
09/02/2010
Recruitment end date
01/02/2012
Locations
Countries of recruitment
Italy
Trial participating centre
A. Meyer University Childrens Hospital
Florence
I-50139
Italy
Funders
Funder type
Government
Funder name
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
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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)
Publication citations
-
Protocol
Filippi L, Fiorini P, Daniotti M, Catarzi S, Savelli S, Fonda C, Bartalena L, Boldrini A, Giampietri M, Scaramuzzo R, Papoff P, Del Balzo F, Spalice A, la Marca G, Malvagia S, Della Bona ML, Donzelli G, Tinelli F, Cioni G, Pisano T, Falchi M, Guerrini R, Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia (NeoNATI)., BMC Pediatr, 2012, 12, 144, doi: 10.1186/1471-2431-12-144.