Cool Prime Comparative Effectiveness Study for Mild HIE (COOLPRIME)
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|ClinicalTrials.gov Identifier: NCT04621279|
Recruitment Status : Not yet recruiting
First Posted : November 9, 2020
Last Update Posted : January 27, 2022
|Condition or disease||Intervention/treatment|
|Mild Hypoxic Ischaemic Encephalopathy of Newborn||Procedure: Normothermia Procedure: Whole body therapeutic hypothermia|
|Study Type :||Observational|
|Estimated Enrollment :||460 participants|
|Official Title:||COOLPRIME: Comparative Effectiveness for Cooling Prospectively Infants With Mild Encephalopathy|
|Estimated Study Start Date :||December 1, 2022|
|Estimated Primary Completion Date :||December 1, 2027|
|Estimated Study Completion Date :||December 1, 2029|
Mild Hypoxic Ischemic Encephaolpathy
Infant ≥ 360/7 weeks with evidence of BOTH 1) perinatal event fetal acidosis and 2) encephalopathy on exam.
Usual care for first 72 hours for neonates with mild encephaolpathy maintaining core temperature 36.0 - 37.0.
Procedure: Whole body therapeutic hypothermia
Whole body therapeutic hypothermia (33.5°C + 0.5°C) for 72 hours begun by 6 hours of age, followed by rewarming at 0.5°C/hour for neonates with mild encephaolpathy per site standard of care practice.
- Composite Bayley IV [ Time Frame: 22-26 months of age. ]To compare the effectiveness of therapeutic hypothermia versus normothermia in each of the developmental domains (cognitive, language, motor) as a three dimensional vector.
- MRI biomarkers [ Time Frame: 4-5 days of age. ]To determine the comparative effectiveness of TH based on the MRI injury score and the MRS measures of n-acetylaspartate and lactate.
- Determine TH effect on prolonged length of stay. [ Time Frame: At time of discharge from hospital, up to 30 days from admission ]Determine TH effect on prolonged length of stay as defined as >7 day.
- Determine TH effect on adverse events. [ Time Frame: At time of discharge from hospital, up to 30 days from admission ]Determine adverse events from therapeutic hypothermia to include prolonged hospital stay shivering and possible exposure to narcotic/sedative agents bradycardia/cardiac arrhythmia, major vessel thrombosis or bleeding, thrombocytopenia and alteration of skin integrity.
- Parental measures of bonding. [ Time Frame: 4 months of age ]Parent-infant Status will be assessed using a validated consisting of Mother-to-Infant Bonding Scale score <2.
- Parent measure of stress. [ Time Frame: 4 months of age. ]Baby Care Questionnaire eliciting parental perspectives on feeding, sleeping, and soothing infants in the home environment and is indicative of a parent's reliance on structure and attunement to child cues and test-retest coefficients >0.81 associated with developmental outcomes.
- Heterogeneity of the Total Sarnat Sore. [ Time Frame: Day of life 1 ]Determine the heterogeneity of the treatment effect across subgroups assessing TH responses as a function of Total Sarnat Score (≥ 5) in the first 6 hours of life in order to identify subgroups at high risk prior to the need to initiate cooling.
- Heterogeneity of amplitude or continuous electroencephalography. [ Time Frame: Day of life 1 ]Determine the heterogeneity of the treatment effect across subgroups assessing the amplitude or continuous electroencephalography (abnormal background <30microvolts or absence of sleep-wake cycles) in the first 6 hours in order to identify subgroups at high risk prior to the need to initiate cooling.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04621279
|Contact: Lina Chalak, MDemail@example.com|
|Contact: Pollieanna Sepulveda, BSN, RNfirstname.lastname@example.org|
|Principal Investigator:||Lina Chalak, MD||University of Texas Southwestern Medical Center|