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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01765218
Other study ID # 1182678
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date February 2013
Est. completion date January 27, 2022

Study information

Verified date May 2024
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal is to see whether topiramate (an anti-epileptic agent) improves the outcome of babies with neonatal hypoxic encephalopathy who are receiving whole body cooling.


Description:

Hypoxic ischemic encephalopathy (HIE) is a devastating and unexpected disease in newborns that affects 1.5-2.6 per 1000 live births. Hypoxic ischemic encephalopathy has a mortality rate of up to 30% and survivors are at significant risk for adverse long-term outcomes, including seizures, cerebral palsy, and developmental delay. The investigators propose a randomized controlled study comparing therapeutic hypothermia alone, or therapeutic hypothermia combined with topiramate. The investigators hypothesize that adjuvant therapy with topiramate will reduce short term severity of HIE including seizures (the primary outcome), a composite HIE severity score, and reduce the time of normalization of the amplitude integrated EEG (aEEG). The investigators further hypothesize, that it will improve longer term outcomes such as developmental outcome. The primary hypothesis is that seizures before hospital discharge (or before 4 weeks post-natal age (which ever is earlier)) will be significantly reduced in the topiramate group compared to the control group


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date January 27, 2022
Est. primary completion date January 27, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Hours
Eligibility Inclusion Criteria: In order to be eligible for cooling the baby must meet all three of the following sets of criteria 1. Be near term (typically =34wks gestation) and be aged < 6h old 2. Have signs of early perinatal depression (EITHER 10 minute Apgar score < 5, OR pH < 7.00 within 60mins of age, OR Base Excess < -12 within 60mins of age, OR need respiratory support at 10min of age due to respiratory depression) 3. Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment Exclusion Criteria: 1. Known congenital myopathy 2. Known congenital neuropathy

Study Design


Intervention

Drug:
Topiramate
Infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.
Placebo
A placebo identical in appearance to the active agent (topiramate)

Locations

Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
Kristin R Hoffman

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients With Seizures Clinical or electrical seizures occuring before hospital discharge or before 4w post-natal age (which ever is earlier) will be compared between the topiramate and control groups. At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier)
See also
  Status Clinical Trial Phase
Withdrawn NCT02551003 - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy Phase 1/Phase 2
Completed NCT02683915 - Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
Recruiting NCT01962233 - Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy Phase 1
Completed NCT01471015 - Darbe Administration in Newborns Undergoing Cooling for Encephalopathy Phase 1/Phase 2
Completed NCT01683383 - California Transport Cooling Trial N/A
Completed NCT01649648 - Autologous Cord Blood Cells for Brain Injury in Term Newborns Phase 1
Completed NCT01481207 - Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
Withdrawn NCT00993564 - Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE) N/A
Completed NCT00945789 - Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE) Phase 1/Phase 2
Completed NCT00097097 - Neonatal Resuscitation in Zambia Phase 3
Recruiting NCT02621944 - Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia Early Phase 1
Not yet recruiting NCT02605018 - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy Phase 1/Phase 2
Withdrawn NCT01128673 - MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE) N/A
Completed NCT01732146 - Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy Phase 3
Completed NCT02349672 - Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
Completed NCT02826941 - Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy Phase 2
Active, not recruiting NCT01138176 - Whole Body Cooling Using Phase Changing Material Phase 1/Phase 2
Recruiting NCT02578823 - Targeted Temperature Management After In-Hospital Cardiac Arrest N/A
Completed NCT01241019 - Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia Phase 2
Completed NCT00620711 - Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy Phase 1