Trial · NCT01765218
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
NCT01765218, Phase 1, Phase 2, Terminated, Kristin R Hoffman; results first posted 2024-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy. Trials, record NCT01765218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01765218
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
- NCT number
- NCT01765218
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- Kristin R Hoffman
- Conditions
- Hypoxic Ischemic Encephalopathy
- Interventions
- Topiramate, Placebo
- First posted
- 2013-01-10
- Last updated
- 2024-06-11
- Results first posted
- 2024-06-11
- 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.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Seizures | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Seizures | At 4 weeks post-natal age or the time of hospital discharge (whichever is earlier) | Participants with Seizures | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Seizures | Placebo | 3 | Participants with Seizures | ||
| Number of Patients With Seizures | Topiramate | 1 | Participants with Seizures |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 17 | |
| Overall Study | STARTED | Topiramate | 17 | |
| Overall Study | COMPLETED | Placebo | 16 | |
| Overall Study | COMPLETED | Topiramate | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Topiramate | 2 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Need for Bronchodilator Therapy | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 17 | 0 |
| other | Need for Bronchodilator Therapy | Respiratory, thoracic and mediastinal disorders | Topiramate | 1 | 17 | 10 |
| other | Need for Bicarbonate or THAM for acidosis | General disorders | Placebo | 2 | 17 | 3 |
| other | Need for Bicarbonate or THAM for acidosis | General disorders | Topiramate | 3 | 17 | 6 |
| serious | Necrotizing Enterocolitis | Gastrointestinal disorders | Placebo | 0 | 17 | 0 |
| serious | Necrotizing Enterocolitis | Gastrointestinal disorders | Topiramate | 0 | 17 | 0 |
| serious | Chronic Lung Disease | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 17 | 0 |
| serious | Chronic Lung Disease | Respiratory, thoracic and mediastinal disorders | Topiramate | 0 | 17 | 0 |
| serious | Sepsis | Infections and infestations | Placebo | 1 | 17 | 1 |
| serious | Sepsis | Infections and infestations | Topiramate | 0 | 17 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 17 |
| Total, all-cause mortality | Topiramate | 0 | 17 |
| Total, other adverse events | Placebo | 2 | 17 |
| Total, other adverse events | Topiramate | 4 | 17 |
| Total, serious adverse events | Placebo | 1 | 17 |
| Total, serious adverse events | Topiramate | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Topiramate vs Placebo: deaths from any cause | Trial comparisons |
| Topiramate vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01765218
GET https://conductscience.org/api/trials/v1/NCT01765218/registered