PACTR202202647130754
Not yet recruiting
Phase 1
Finding solutions to thrive after birth asphyxia in Africa: An open-label dose-finding clinical trial (Phase Ib study) - SANE-Uganda
Research Institute of the McGill University Health Centre0 sites30 target enrollmentFebruary 9, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Research Institute of the McGill University Health Centre
- Enrollment
- 30
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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