Preventive dobutamine use in newborns with brain injury from birth as part of cooling

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 Phase 2 pilot trial evaluates whether beginning dobutamine within the first four hours of therapeutic hypothermia in newborns with HIE is feasible and safe. It uses prophylactic inotropy (dobutamine) and therapeutic hypothermia to manage cardiovascular stability and cerebral perfusion. The study looks at short-term in-hospital outcomes, including heart function and brain injury severity, to see if early heart support can improve overall recovery. Enrollment is limited to newborns with HIE undergoing TH, and excludes those with contraindications to dobutamine or who are already on inotropes. The trial is hosted at the University of Alberta's Philip C. Etches NICU in Edmonton, with collaboration at Royal Alexandra Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Newborns with hypoxemic ischemic encephalopathy (HIE) receiving therapeutic hypothermia (TH).

Exclusion Criteria:

1. Congenital abnormality
2. known contraindication of dobutamine

   * Left ventricular outflow tract dynamic obstruction
   * Hypersensitivity to dobutamine
   * Uncorrected tachyarrhythmias or ventricular fibrillation
3. Newborns who are already started on inotropes at the time of randomization.
4. Parental refusal to consent to participate

Where it's running

• Philip C. Etches Neonatal Intensive Care Unit (Royal Alexandra Hospital)
  Edmonton, Alberta, Canada Recruiting
• Royal Alexandra Hospital
  Edmonton, Alberta, Canada Not yet recruiting

Study contacts

• Study coordinator: Aimann Surak, MD FRCPC DRCPSC
• Email: aimann@ualberta.ca
• Phone: 780-735-4647

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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.