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Finding Solutions to Thrive After Birth Asphyxia in Africa — SANE-Uganda  

Birth Asphyxia Clinical Trial

Official title:
Finding Solutions to Thrive After Birth Asphyxia in Africa: An Open-label Dose-finding Clinical Trial (Phase Ib Study)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05275725
Study type Interventional
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact Pia Wintermark, MD
Phone 514-412-4452
Email pia.wintermark@mcgill.ca
Status Recruiting
Phase Phase 1
Start date July 1, 2022
Completion date December 2024
View Details
See also
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