Condition category
Neonatal Diseases
Date applied
26/11/2010
Date assigned
06/06/2011
Last edited
11/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luca Filippi

ORCID ID

Contact details

A. Meyer University Children’s 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

EudraCT: 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 measures

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

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 Children’s Hospital
Florence
I-50139
Italy

Sponsor information

Organisation

A. Meyer University Children’s Hospital (Italy)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22950861

Publication citations

  1. 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.

Additional files

Editorial Notes