At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Therapeutic Hypothermia (device)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Therapeutic Hypothermia — device: Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, A zero hour cooling duration (normothermia) treatment arm will be opened for enrollment if there is not an increase in the treatment effect across the durations.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called P-ICECAP, looks at children aged 2 days to under 18 years whose heart stopped outside hospital (out-of-hospital cardiac arrest). It is exploring how long cooling the body (induced hypothermia) should last after the heart is restarted, to help protect the brain from lack of oxygen. The study is sponsored by the University of Michigan.
Who can take part
- Aged 2 days to under 18 years, born after at least 38 weeks of pregnancy
- Received chest compressions for at least 2 minutes
- In a coma or showing signs of brain injury after being resuscitated from a cardiac arrest outside hospital
- Needs help breathing from a machine through a tube in the throat (windpipe) or neck
- Already started on a device to control body temperature
- Able to join the study within 6 hours of the heart restarting
- A parent or legal representative gives consent, including agreeing to keep life support in place for 120 hours (5 days)
Who may not be able to
- Can obey simple commands normally (Glasgow Coma Motor Score of 6)
- Parent or legal representative does not speak English or Spanish
- Chest compressions lasted more than 60 minutes
- Severe blood pressure problems needing high-dose adrenaline or noradrenaline medicines, or a heart-lung bypass machine (ECMO)
- Already had serious developmental problems or a worsening brain disease
- Already had a terminal illness and unlikely to live more than a year
- The cardiac arrest was linked to an injury to the brain, chest or tummy
- Severe ongoing bleeding before joining
- Extensive burns or skin damage that would stop surface cooling
- Plans to stop life support before 120 hours
- Sickle cell anaemia
- An existing condition where proteins in the blood clump together in the cold (cryoglobulinaemia)
- Nearly drowned under ice-covered water
- A brain tumour currently being treated with chemotherapy
- Already took part in the P-ICECAP trial before
- In prison
- Long-term low body temperature (chronic hypothermia)
- New diabetes insipidus (a kidney watering problem) after the cardiac arrest
- Pregnant
What taking part involves
- • Cooling the body for a period of time using a temperature control device — the study compares different cooling durations. Further details of the treatment schedule are not stated — ask the trial team.
Time commitment: Life support must be maintained for 120 hours (5 days) after joining, and joining must happen within 6 hours of the heart restarting; other visit and follow-up details are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 2 Days to 17 Years
- Who
- All
- Number of participants
- 900
- Started
- 2022-08-05
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for cardiac arrest, out-of-hospital
- • NA - 900 participants
- • This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest
Who can take part?
- • Ages 2 Days to 17 Years
- • Diagnosed with cardiac arrest, out-of-hospital
Where?
- • Bristol - Bristol Royal Hospital for Children
- • London - Evelina London Children's Hospital
- • Birmingham - Birmingham Children's Hospital, United Kingdom
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 2 Days - 17 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ continuous mechanical ventilation through endotracheal tube or tracheostomy
What the study is looking for
- ✓Age 2 days to \< 18 years with corrected gestational age of at least 38 weeks
- ✓Chest compressions for at least 2 minutes
- ✓Coma or encephalopathy after resuscitation from Out-of-Hospital heart Arrest (OHCA)
- ✓Requires continuous mechanical ventilation through endotracheal tube or tracheostomy
- ✓Definitive temperature control device initiated
Who cannot take part
- ✗Glasgow Coma Motor Score (GCMS) = 6
- ✗LAR does not speak English or Spanish
- ✗Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes
- ✗Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or...
- ✗Pre-existing terminal illness, unlikely to survive to one year
See the full criteria
Where Is This Study? (3 UK sites)
Bristol Royal Hospital for Children
Bristol BS2 8BJ, United Kingdom
Evelina London Children's Hospital
London SE17EH, United Kingdom
Birmingham Children's Hospital, United Kingdom
Birmingham, United Kingdom
How to Get in Touch
Frank Moler, MD
Sponsor contactCONTACT
Moni Weber
Sponsor contactCONTACT
