drugset / Trial / NCT05275725

Finding Solutions to Thrive After Birth Asphyxia in Africa

NCT05275725

NaSingle-groupOpen-labelTreatment

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 often lack the resources to care for affected children. For those with disabilities, stigma is high, and social and emotional impacts are substantial. Improving our understanding of NE in LICs is crucial if intervention strategies are developed. Providing access to an affordable and easy-to-administer treatment after birth may improve survival, early brain development and later outcome, maximizing developmental potential. The primary objective of this study is to investigate the feasibility, safety and tolerability of administering sildenafil as a neuroprotective/neurorestorative strategy to improve early brain development in a cohort of children with NE in Uganda.

Timeline

Start
2022-07-01
Primary completion
2025-01-31
Completion
2025-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Sildenafil Unknown 2 mg/kg
Subject Sildenafil Unknown 2.5 mg/kg
Subject Sildenafil Unknown 3 mg/kg

Indications