Neonatal Diseases
Conditions
Interventions
Sildenafil
Sponsors
Research Institute of the McGill University Health Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female neonates meeting the criteria for birth asphyxia: - Gestational age = 36 weeks and birth weight = 1800 g; - Admitted to Kawempe Hospital or Nsambya Hospital within 48 hours of life; - Need for continued resuscitation after birth and/or 5-minute Apgar score =5; - Evidence of neonatal encephalopathy by an abnormal neurological exam (modified Sarnat score of 2-3 or abnormal aEEG).
Exclusion criteria
Exclusion criteria: - Absent heart rate at 10 minutes/imminent death - Neonates with major congenital malformations - Neonates with grade 3 AKI (serum creatinine rise =3x lowest previous creatinine or creatinine > 2.5 mg/dL = 221 mcmol/L or receipt of dialysis) - Neonates with intraventricular and/or intraparenchymal hemorrhage on cranial ultrasound (cUS) performed on day 1-2 of life - Mother living permanently outside 20km radius of Kawempe Hospital or Nsambya Hospital - Neonates whose parents are unwilling or unable to give informed written consent to enter the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerable dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Sildenafil safety;Sildenafil pharmacokinetics and pharmacodynamics | — |
Countries
Uganda
Contacts
Public ContactPia Wintermark
Associate Professor of Pediatrics
Outcome results
None listed