An interventional study of Passive cooling application and cooling using Blanket roll III in Hypoxic Encephalopathy, Birth Asphyxia and Neonatal Encephalopathy, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 1 Hour to 6 Hours. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Alexandria University · Not applicable, Interventional, and Diagnostic
Studying the effect of passive versus Blanket roll III modality of therapeutic hypothermia (TH)on myocardial function of asphyxiated neonates through using tissue Doppler (TD).
A clinical trial study of 100 Gestational-age-matched asphyxiated cooled neonates will divided into two groups, 50 in each group for comparison the myocardial function using passive cooling and BLANKET ROLL III as modality of TH.
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's enrollment of 100 is above the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of:
Exclusion Criteria:
Device: Passive cooling application
Device: cooling using Blanket roll III
Passive cooling application for asphyxiated neonates and their effect on myocardial function and hemodynamics
standard care using Blanket roll III in asphyxiated neonates and their effect on myocardial function and hemodynamics
Myocardial function through using tissue Doppler (TD).
neonatal echocardiography using a (Vivid IQ) with a (3-8 MHz) with software for Tissue Doppler imaging (TDI) , myocardial performance index and measuring velocities of different waveforms, cm/sec.
Time frame: first 4 days of life
Left ventricular function through using conventional echocardiography.
Ejection fraction in percent .
Time frame: first 4 days of life
Right ventricular function using conventional echocardiography
TAPSE (tricuspid annular plane systolic excursion) in mm .
Time frame: first 4 days of life
Ran from Jan 2022 to primary completion in Apr 2023, 15 months.
Of 33 non-industry interventional studies with no phase under Hypoxia, Brain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 44. This study's 15 months is below that.
Counting every sponsor, half of 33 studies reached it within 20 months; a quarter within 7 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.