Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsNA

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Sponsor: University of Michigan

NCT ID: NCT05376267

View on ClinicalTrials.gov ↗

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.

Cardiac Arrest, Out-Of-HospitalHypothermia, InducedHypoxia-Ischemia, Brain

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion criteria: * 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 Cardiac Arrest (OHCA) * Requires continuous mechanical ventilation through endotracheal tube or tracheostomy * Definitive temperature control device initiated * Randomization within 6 hours of Return of Spontaneous Circulation (ROSC) * Informed consent from Legally Authorized Representative (LAR) including intent to maintain life support for 120 hours Exclusion criteria: * Glasgow Coma Motor Score (GCMS) = 6 * LAR does not speak English or Spanish * Duration of Cardiopulmonary Resuscitation (CPR) \> 60 minutes * Severe hemodynamic instability with continuous infusion of epinephrine or norepinephrine of 2 micrograms per kilogram per minute (μg/kg/minute) or initiation of Extracorporeal membrane oxygenation (ECMO) * Pre-existing severe neurodevelopmental deficits with Pediatric Cerebral Performance Category (PCPC) =5 or progressive degenerative encephalopathy * Pre-existing terminal illness, unlikely to survive to one year * Cardiac arrest associated with brain, thoracic, or abdominal trauma * Active and refractory severe bleeding prior to randomization * Extensive burns or skin lesions incompatible with surface cooling * Planned early withdrawal of life support before 120 hours * Sickle cell anemia * Pre-existing cryoglobulinemia * Non-fatal drowning in ice covered water * Central nervous system tumor with ongoing chemotherapy * Previous enrollment in P-ICECAP trial * Prisoner * Chronic hypothermia * New post-cardiac arrest diabetes insipidus * Pregnancy

Where Is This Study? (3 UK sites)

Bristol Royal Hospital for Children

Bristol BS2 8BJ, United Kingdom

Recruiting
Site contact (verified)
Omar Aziz, MSC, MRCGP, MRCPCH, DGM44 3788956254Omer.Aziz@uhbw.nhs.uk

Evelina London Children's Hospital

London SE17EH, United Kingdom

Recruiting
Site contact (verified)

Birmingham Children's Hospital, United Kingdom

Birmingham, United Kingdom

Recruiting
Site contact (verified)
Hari Krishnan, MDPrincipal Investigator
Hari Krishnan, MDhari.krishnan2@nhs.net

How to Get in Touch

Frank Moler, MD

Sponsor contact

CONTACT

734-764-5302 fmoler@umich.edu

Moni Weber

Sponsor contact

CONTACT

734-232-4803 monij@umich.edu
Data sourced from ClinicalTrials.gov · Last verified: 2026-08