Trial · NCT01646619
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| 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 |
| Secondary | Major venous thrombosis | Duration of hospital stay, an expected average of up to 4 weeks | The development of major venous thrombosis or a major vein thrombus during the patient's hospital stay will be recorded. |
| Secondary | Renal Failure | Duration of hospital stay, an expected average of up to 4 weeks | The development of renal failure during the patient's hospital stay will be recorded |
| Secondary | Abnormal liver funcion tests (elevated liver enzymes) | Duration of hospital stay, an expected average of up to 4 weeks | The devlopment of raised liver enzymes during the patient's hospital stay will be recorded. |
| Secondary | Pneumonia | Duration of hospital stay, an expected average of up to 4 weeks | The development of pneumonia during the patient's hospital stay will be assessed and recorded. |
| Secondary | Pulmonary air leak syndrome | Duration of hospital stay, an expected average of up to 4 weeks | The development of pulmonary air leak syndrome during the patient's hospital stay will be recorded. |
| Secondary | Prolonged vs shortened hospital stay | First day of NICU admission till the day of discharge, an expected average of up to 4 weeks | The entire duration of hopital stay will be assessed |
| Secondary | Neurodevelopment score | On the day of discharge from hospital, an expected average of 4 weeks after admission | A developmental paediatrician blinded to the study groups will assess the patient's neurodevlopment on the day of his or her discharge. |
| Secondary | Abnormal aEEG | Before randomization and during hypothermia therapy (0 hours till 96 hours) | The aEEG is used to measure the severity of Hypoxic Ischemic Encephalopathy (moderate or severe). |
| Secondary | Presence of multiple handicaps | 18-24 months of age | Multiple handicaps (( defined as the presence of any two of the following in an infant at the age of 18-24 months: neuromotor disability (level 3-5 on GMF Classification), mental delay (Bayley MDI score \<70),epilepsy, cortical visual impairment, sensorineural hearing loss)). |
| Secondary | Bayley Psychomotor Development Score less than 70 | 18-24 months of age |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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