Status:
ACTIVE_NOT_RECRUITING
Finding Solutions to Thrive After Birth Asphyxia in Africa
Lead Sponsor:
Pia Wintermark
Collaborating Sponsors:
Kawempe National Referral Hospital
Saint Francis Hospital
Conditions:
Birth Asphyxia
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief Summary
Neonatal encephalopathy (NE) is the third leading cause of under 5-year mortality and contributes substantially to long-term neurological morbidity worldwide. In low-income countries (LICs), families ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05275725
Start Date
July 1 2022
End Date
January 31 2025
Last Update
December 31 2024
Active Locations (1)
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1
Kawempe National Referral Hospital
Kawempe, Uganda