CompletedNot Applicable

Passive Cooling Versus Blanket-Roll III on The Myocardial Function of Asphyxiated Neonates

Egypt100 participantsStarted 2022-01-20

Plain-language summary

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).

Who can participate

Age range

1 Hour – 6 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Evidence of perinatal/intrapartum hypoxia, as indicated by at least one of: * Apgar score of less than or equal to 5 at 10 minutes * Needing mechanical ventilation or ongoing resuscitation at 10 minutes * PH in cord blood gas is less than 7.00 or a base excess worse than or equal to minus 12 mmol /L on cord/arterial/venous/capillary blood gas obtained within 60 minutes of birth. * Evidence of moderate or severe encephalopathy. * Greater than or equal to 35 weeks gestational age. * Birth weight greater than or equal to 1800 g. * Able to begin cooling before 6 hours of birth. Exclusion Criteria: * Congenital cyanotic heart disease. * Multiple congenital anomalies. * Birth asphyxia's babies after start of cooling with cardiovascular instability.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Myocardial function through using tissue Doppler (TD).

Timeframe: first 4 days of life

Left ventricular function through using conventional echocardiography.

Timeframe: first 4 days of life

Trial details

NCT IDNCT05652738

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-20

View on ClinicalTrials.gov More Hypoxic Encephalopathy trials

Who can participate

Age range

1 Hour – 6 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.