Trial of Intracranial Pressure Monitoring in Pediatric Severe Traumatic Brain Injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates whether treatment for severe traumatic brain injury (sTBI) in children, guided by invasive intracranial pressure (ICP) monitoring, leads to better outcomes compared to treatment based solely on imaging and clinical examination. Conducted in eight pediatric ICUs across Latin America, the study aims to enhance clinical practices and research capacity in the region. The trial will involve randomizing eligible patients within 24 hours of injury or deterioration, focusing on those aged 1 to 12 years with a Glasgow Coma Scale (GCS) score of 8 or less. Findings from this trial are expected to inform global treatment guidelines for pediatric TBI.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form by the parent(s) or guardian(s)
2. Non-penetrating TBI
3. Admission to study hospital within 24 hours of injury
4. Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children \< 2 years old and standard GCS for older children)
5. Age 1 through 12 years
6. Able to randomize:

   * Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR
   * Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)

Exclusion Criteria:

1. Motor GCS score of 6
2. GCS of 3 with bilaterally fixed and dilated pupils
3. Injury thought to be intentionally inflicted by a family member or caregiver.

Where it's running

• Fundación Hospital de la Misericordia
  Bogotá, Colombia Recruiting
• Hospital Fundacion Amigos de la Salud
  Montería, Colombia Recruiting
• Hospital de Niños Benjamín Bloom
  San Salvador, El Salvador Recruiting
• Hospital Regional de Esquintla
  Escuintla, Guatemala Recruiting
• Hospital General San Juan de Dios
  Guatemala City, Guatemala Recruiting
• Hospital Regional de Occidente San Juan de Dios
  Quetzaltenango, Guatemala Recruiting

Study contacts

• Principal investigator: Randall Chesnut, MD — University of Washington
• Study coordinator: Randall M Chesnut, MD
• Email: chesnutr@uw.edu
• Phone: 2067449322

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dual-Site Ear Nerve Stimulation for Severe Brain Injury-Related Coma

  This study tests a gentle, non-invasive stimulation on the left ear to try to help some people in coma due to severe traumatic brain injury regain awareness.

  Recruiting Stony Brook University · Stony Brook, New York · NCT07719595

• Neutral fluid balance in adults with traumatic brain injury (LIMIT-TBI)

  This study tests whether keeping daily fluid balance around zero (within 500 mL) for the first 5 days in the ICU is feasible and safe for adults with traumatic brain injury.

  Recruiting at 3 sites Phase 2 Erasme University Hospital · Brussels and 2 other locations · NCT07625995

• SeeMe: automated facial and hand tracking to reveal hidden responses after traumatic brain injury

  This project tests whether a high-resolution camera system with AI can detect very small, voluntary facial and hand movements in adults with severe traumatic brain injury who appear unresponsive.

  Recruiting Stony Brook University · Stony Brook, New York · NCT07560631

• Prognostic model for neurocritical patients using multimodal brain monitoring

  This study tests a model that uses EEG, TCD, and NIRS data to predict 90-day outcomes (awake, coma, or death) in adults with acute brain injuries in intensive care.

  Recruiting Xiangya Hospital of Central South University · Changsha, Hunan · NCT07115459

• Understanding cerebral vasospasm in traumatic brain injury with subarachnoid hemorrhage

  This study is testing how common and serious blood vessel narrowing in the brain is for adults with moderate to severe traumatic brain injuries and bleeding, to see if better scans can help improve their care.

  Recruiting University Hospital Center of Martinique · Fort-de-France · NCT06560372

• Using external lumbar drainage to lower brain pressure in severe traumatic brain injury

  This study is testing if using a special drainage method can safely lower brain pressure in people with severe traumatic brain injuries while they receive standard care.

  Recruiting at 6 sites Brain Trauma Foundation · Gainesville, Florida and 5 other locations · NCT05889650

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.