NCT01765218

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2022

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

June 11, 2024

Completed
Last Updated

June 11, 2024

Status Verified

May 1, 2024

Enrollment Period

9 years

First QC Date

January 7, 2013

Results QC Date

December 19, 2023

Last Update Submit

May 15, 2024

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic ischemic encephalopathyHIEPerinatal depressionWhole body coolingTherapeutic hypothermia

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)

Drug: Placebo

Topiramate

ACTIVE COMPARATOR

In addition to whole body cooling, 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.

Drug: Topiramate

Interventions

TopiramateDRUG

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.

Also known as: Topamax, Topiragen
Topiramate
PlaceboDRUG

A placebo identical in appearance to the active agent (topiramate)

Placebo

Eligibility Criteria

AgeUp to 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • In order to be eligible for cooling the baby must meet all three of the following sets of criteria
  • Be near term (typically ≥34wks gestation) and be aged \< 6h old
  • 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)
  • Have signs of moderate or severe encephalopathy based on either clinical examination or on amplitude integrated aEEG assessment

You may not qualify if:

  • Known congenital myopathy
  • Known congenital neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95822, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Limitations and Caveats

Study was stopped short of intended recruitment due to difficulty with recruitment during COVID pandemic and changes to the therapeutic hypothermia protocol at our institution.

Results Point of Contact

Title
Kristin Hoffman, MD
Organization
University of California, Davis
krhoffman@ucdavis.edu
916-205-2755

Study Officials

  • Kristin R Hoffman, MD

    UC Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Clinical Pediatrics

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 10, 2013

Study Start

February 1, 2013

Primary Completion

January 27, 2022

Study Completion

January 27, 2022

Last Updated

June 11, 2024

Results First Posted

June 11, 2024

Record last verified: 2024-05

Locations

US(1)