Phase 3 PTSD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children aged from 44 weeks post-menstrual age (a measure used for premature babies) up to 11 years old (confirm with trial site if unsure how age is calculated)
• Children who are planned to be admitted to the pediatric ICU at Monroe Carell Jr. Children's Hospital at Vanderbilt
• Children who need a breathing machine (mechanical ventilator) and sedation medication to keep them calm and comfortable

Who may not be able to join:

• Children who have already been on continuous sedation for more than 72 hours before being assessed for the trial
• Children whose breathing problems are clearing up quickly and who are expected to be taken off the breathing machine very soon
• Children who had significant pre-existing cognitive or developmental disability before their current illness, based on a specific medical rating scale (confirm with trial site)
• Children with certain serious heart rhythm problems or a heart rate below 60 beats per minute
• Children who are medically dependent on a continuous drip of benzodiazepine (a type of sedation medication)
• Children who cannot be enrolled alongside another research study at the same time
• Children who are expected to pass away or have a plan to stop life-sustaining treatment within 24 hours of joining
• Children with total vision loss in both eyes
• Children with deafness that would prevent doctors from being able to assess them for delirium (a state of confusion)
• Children who cannot understand English well enough for delirium testing to be completed — though this may not apply if research staff or translation services are available in the child's language (confirm with trial site)
• Children with a documented allergy to either of the two study medications: dexmedetomidine or midazolam
• Children who are expected to need continuous muscle-paralysing medication (neuromuscular blockade) for at least 48 hours at the time of assessment
• Children whose weight at the time of assessment is above 50 kilograms
• Cases where the consent process cannot be started within 72 hours of the child first meeting all the eligibility requirements — for example, if the child's legal guardian is unavailable, declines, or does not speak a language that available staff or translators can support

Important: Always verify eligibility with the trial site directly before applying.