A clinical trial of topiramate vs placebo for newborns with perinatal asficia body treated with hypothermia.

• Conditions: Asphyxiated newborn infants evolving to moderate-to-severe hypoxic ischemic encephalopathy; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-005696-17-ES
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-21
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Signed informed consent by parents or legal guardians.
? Term near term gestation (?36weeks)
? Birth weight ? 2000g
? Significant moderate to severe Hypoxic Ischemic Encephalopathy, estimated with the modified Sarnat classification (see Annex 2)
? Evident signs of asphyxia during labor: meconium and/or alteration of fetal heart rate.
? Inborn in referral center or arrival to referral center within the acceptable timeframe for initiating hypothermia (6 hours after birth).
? The patient must meet at least, one criteria of A and one of B:
A. Existence of perinatal data compatible with peripartum hypoxic ischemia:
- Non-reassuring fetal status during fetal monitoring
- Pathological scalp pH (<7.2)
- Hypoxic-ischemic sentinel signs (cord prolapse, placenta abruptio, uterine rupture, severe fetal hemorrhage); dystocia during delivery.
B. Objective status of perinatal affectation:
- Apgar score ? 5 at 5 minutes after birth
- Need of resuscitation with positive pressure ventilation (with mask or E.T.) at 10 minutes from birth.
pH ? 7 estimated at worse gasometry during the first 60 minutes (cordon, arterial, venous or capilar blood)
- Base Deficit (BE) ? 16 mmol/L estimated at worse gasometry during the first 60 minutes (cordon, arterial, venous or capilar blood)
Are the trial subjects under 18? yes
Number of subjects for this age range: 152
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Gestational age <36weeks? gestation
? Birth weight < 2000g
? Any pathology requiring surgery prior to discharge
? Major congenital malformations
? Imminent death
? Chromosomopathies
? Rejection to participate or to sign inform consent
? Erroneous or impossibility for randomization
? Incapability of initiating active or passive hypothermia (rectal temperature ? 34ºC) within the 6 hours timeframe
? Use of another investigational agent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified