Trial Outcomes & Findings for Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy (NCT NCT01765218)
NCT ID: NCT01765218
Last Updated: 2024-06-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier)
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
Placebo
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
Placebo: A placebo identical in appearance to the active agent (topiramate)
|
Topiramate
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
Placebo: A placebo identical in appearance to the active agent (topiramate)
|
Topiramate
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.
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
Baseline Characteristics
Randomization did not account for gender
Baseline characteristics by cohort
| Measure |
Placebo
n=17 Participants
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
Placebo: A placebo identical in appearance to the active agent (topiramate)
|
Topiramate
n=17 Participants
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.
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Gestational Age
|
39.12 Weeks
n=99 Participants
|
38.88 Weeks
n=107 Participants
|
39 Weeks
n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants • Randomization did not account for gender
|
5 Participants
n=107 Participants • Randomization did not account for gender
|
15 Participants
n=206 Participants • Randomization did not account for gender
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants • Randomization did not account for gender
|
12 Participants
n=107 Participants • Randomization did not account for gender
|
19 Participants
n=206 Participants • Randomization did not account for gender
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • Many participants marked "Other"
|
0 Participants
n=107 Participants • Many participants marked "Other"
|
0 Participants
n=206 Participants • Many participants marked "Other"
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants • Many participants marked "Other"
|
2 Participants
n=107 Participants • Many participants marked "Other"
|
5 Participants
n=206 Participants • Many participants marked "Other"
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Many participants marked "Other"
|
1 Participants
n=107 Participants • Many participants marked "Other"
|
1 Participants
n=206 Participants • Many participants marked "Other"
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants • Many participants marked "Other"
|
0 Participants
n=107 Participants • Many participants marked "Other"
|
0 Participants
n=206 Participants • Many participants marked "Other"
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants • Many participants marked "Other"
|
5 Participants
n=107 Participants • Many participants marked "Other"
|
10 Participants
n=206 Participants • Many participants marked "Other"
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants • Many participants marked "Other"
|
1 Participants
n=107 Participants • Many participants marked "Other"
|
4 Participants
n=206 Participants • Many participants marked "Other"
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants • Many participants marked "Other"
|
8 Participants
n=107 Participants • Many participants marked "Other"
|
14 Participants
n=206 Participants • Many participants marked "Other"
|
|
Birth Weight (g)
|
3236.14 grams
n=99 Participants • Birth Weight as measured in Grams between the two arms
|
3159.24 grams
n=107 Participants • Birth Weight as measured in Grams between the two arms
|
3197.46 grams
n=206 Participants • Birth Weight as measured in Grams between the two arms
|
PRIMARY outcome
Timeframe: At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier)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.
Outcome measures
| Measure |
Placebo
n=17 Participants
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
Placebo: A placebo identical in appearance to the active agent (topiramate)
|
Topiramate
n=17 Participants
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.
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.
|
|---|---|---|
|
Number of Patients With Seizures
|
3 Participants with Seizures
|
1 Participants with Seizures
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Topiramate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=17 participants at risk
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
Placebo: A placebo identical in appearance to the active agent (topiramate)
|
Topiramate
n=17 participants at risk
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.
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.
|
|---|---|---|
|
Gastrointestinal disorders
Necrotizing Enterocolitis
|
0.00%
0/17 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
0.00%
0/17 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Lung Disease
|
0.00%
0/17 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
0.00%
0/17 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
|
Infections and infestations
Sepsis
|
5.9%
1/17 • Number of events 1 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
0.00%
0/17 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
Other adverse events
| Measure |
Placebo
n=17 participants at risk
Subjects will receive the standard of care intervention for HIE at our institution (whole body cooling for 72h followed by gradual rewarming)
Placebo: A placebo identical in appearance to the active agent (topiramate)
|
Topiramate
n=17 participants at risk
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.
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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Need for Bronchodilator Therapy
|
0.00%
0/17 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
5.9%
1/17 • Number of events 10 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
|
General disorders
Need for Bicarbonate or THAM for acidosis
|
11.8%
2/17 • Number of events 3 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
17.6%
3/17 • Number of events 6 • Data was collected until discharge, typically less than one month
Charts were reviewed to collect adverse event data.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place