Sildenafil for Neonatal Asphyxia (SANE-02 Trial)

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia. They will use a 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on their brain and cardiopulmonary hemodynamics, without causing serious adverse events

Eligibility Criteria

This trial is for newborns who are at least 36 weeks old, weigh over 1800 grams, and have suffered from birth asphyxia leading to brain injury. They must show signs of distress like low Apgar scores or poor blood gas levels and have evidence of brain injury on an MRI. Babies with complex heart disease, genetic syndromes, or certain types of bleeding in the brain can't participate.

Inclusion Criteria

My newborn has signs of severe brain injury confirmed by tests.

Exclusion Criteria

My newborn has a genetic syndrome.

My newborn has brain malformations.

My newborn had a brain bleed detected by MRI on their second day.

My newborn has a complex heart condition present from birth.

Participant Groups

The study is testing different doses of Sildenafil Citrate up to a maximum of 6 mg/kg/day in newborns with brain injuries from asphyxia despite being cooled (hypothermia treatment). Researchers want to find the highest dose babies can tolerate without serious side effects and see if it helps their brains and hearts.

1Treatment groups

Experimental Treatment

Group I: SildenafilExperimental Treatment1 Intervention