Trial · NCT01862250
Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
NCT01862250, Phase 1, Phase 2, Completed, Johns Hopkins University; results first posted 2018-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia. Trials, record NCT01862250. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01862250
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia
- NCT number
- NCT01862250
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Encephalopathy, Hypoxic-Ischemic
- Interventions
- Clonidine (Duraclon®)
- First posted
- 2013-05-24
- Last updated
- 2018-01-05
- Results first posted
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Steady State Clonidine Blood Levels During Hypothermia | 3 days | Trough clonidine blood levels were measured after 4-7 doses of clonidine were given intravenously with a dosing interval of every 8 hrs. Mean and standard deviation (SD) of the number of doses given prior to levels being drawn was 5.3 (mean) and 0.37 (SD). Time after last dose before measurement was 9hrs (mean) and 2.7hrs (SD). |
| Primary | Amount of Morphine Given | Up to 2 days | Intravenous morphine (mg/kg) was given. The standard dose is 0.05 mg/kg per dose |
| Secondary | Presence of Shivering After Clonidine | 48hrs | Babies were assessed after administration of clonidine for the presence or absence of shivering. |
| Secondary | Time to Passive Rewarming | Beginning at 72 hours up to 12 hours | Following 2 hours of therapeutic hypothermia, the temperature of the thermo-blanket is adjusted up half degree per hour allowing passive rewarming until 36.5 degrees is reached |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Steady State Clonidine Blood Levels During Hypothermia | 3 days | Only 8 babies were assessed for this outcome because the rest did not have a steady state trough level performed during cooling | ng/ml | MEDIAN |
| PRIMARY | Amount of Morphine Given | Up to 2 days | mg/kg | MEDIAN | |
| SECONDARY | Presence of Shivering After Clonidine | 48hrs | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Passive Rewarming | Beginning at 72 hours up to 12 hours | Hours | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Steady State Clonidine Blood Levels During Hypothermia | Clonidine Infants With HIE | 0.6 | Full Range 0.27 to 1.06 | ng/ml | |
| Amount of Morphine Given | Clonidine Infants With HIE | 0.02 | Inter-Quartile Range 0.00 to 0.08 | mg/kg | |
| Presence of Shivering After Clonidine | Clonidine Infants With HIE | 0 | Participants | ||
| Time to Passive Rewarming | Clonidine Infants With HIE | 8.7 | Inter-Quartile Range 7.4 to 10.1 | Hours |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Clonidine Infants With HIE | 12 | |
| Overall Study | COMPLETED | Clonidine Infants With HIE | 8 | |
| Overall Study | NOT COMPLETED | Clonidine Infants With HIE | 4 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clonidine Infants With HIE | 0 | 12 |
| Total, other adverse events | Clonidine Infants With HIE | 0 | 12 |
| Total, serious adverse events | Clonidine Infants With HIE | 0 | 12 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01862250
GET https://conductscience.org/api/trials/v1/NCT01862250/registered