Finding solutions to thrive after birth asphyxia in Africa: An open-label dose-finding clinical trial (Phase Ib study)- SANE-Uganda

Phase 1

• Conditions: Neonatal Diseases

• Registration Number: PACTR202202647130754
• Lead Sponsor: Research Institute of the McGill University Health Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified