Trial · NCT01646619
Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
NCT01646619, Phase 3, Unknown, Sajjad Rahman
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy. Trials, record NCT01646619. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646619
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy Study of Hypothermia Plus Magnesium Sulphate(MgSO4) in the Management of Term and Near Term Babies With Hypoxic Ischemic Encephalopathy
- NCT number
- NCT01646619
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Sajjad Rahman
- Conditions
- Severe Hypoxic Ischemic Encephalopathy, Moderate Hypoxic Ischemic Encephalopathy
- Interventions
- Magnesium Sulphate, Placebo
- First posted
- 2012-07-20
- Last updated
- 2013-04-04
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Combined outcome of Mortality and Severe Neurodevelopmental Disability | 18 - 24 months of age | Severe Neurodevelopmental Disability will be assessed at discharge from hospital and at 18-24 months of age to assess developmental delay and cerebral palsy using the Bayley Scale of Infant Development II. |
| Secondary | Persistent Hypotension | Duration of hypothermia therapy( ie during the first 96 hours) | The development of persistently low blood pressure despite adequate measures to maintain normal blood pressure will be assessed and recorded throughout the hypothermia therapy. |
| Secondary | Pulmonary Hemorrhage | Duration of hospital stay, an expected average of up to 4 weeks | The development of Pulmonary hemorrhage at any stage during the patient's hospital stay will be recorded. |
| Secondary | Intracranial Hemorrhage | Duration of hospital stay, an expected average of up to 4 weeks | The development of Intracranial Hemorrhage at any stage during the patient's hospital stay will be recorded by serial head ultrasounds on day 1 , day 3 and as required. |
| Secondary | Pulmonary Hypertension | Duration of Hypothermia therapy (ie during the first 96 hours) | The development of pulmonary hypertension at any stage during the patient's hospital stay will be recorded. |
| Secondary | Prolonged Blood Coagulation time | Duration of hypothermia therapy ( ie during the first 96 hours) | The development of abnormal coagulation profile during hypothermia therapy will be recorded. |
| Secondary | Culture Proven sepsis | Duration of hospital stay, an expected average of up to 4 weeks | The development of sepsis with a positive blood culture during the patient's hospital stay will be recorded. |
| Secondary | Necrotizing enterocolitis | Duration of hospital stay, an expected average of up to 4 weeks | The development of necrotizing enterocolitis during the patient's hospital stay will be recorded. |
| Secondary | Cardiac Arrhythmias | Duration of hypothermia therapy (ie during the first 96 hours) | The development ofcardiac arrythmia during hypothermia therapy will be recorded. |
| Secondary | Thrombocytopenia | Duration of hypothermia therapy (ie during the first 96 hours) | The development of low platelet count (\<20,000) during hypothermia therapy will be recorded |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers15
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/NCT01646619
GET https://conductscience.org/api/trials/v1/NCT01646619/registered?page=2