Finding Solutions to Thrive After Birth Asphyxia in Africa

Birth Asphyxia Clinical Trial

— SANE-Uganda  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275725
• Other study ID #: SANE-Uganda
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• 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
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 18 Months

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia

Intervention

Drug:
• Sildenafil
Dose group 1st dose 2nd dose 3rd dose 4-14th doses Treatment Total dose/day frequency dose/day Group 1: #1-14=2 mg/kg q12h (4 mg/kg/day) Group 2: #1 = 2 mg/kg, #2-14 = 2.5 mg/kg q12h (5 mg/kg/day) Group 3: #1 = 2 mg/kg, #2 = 2.5 mg/kg, #3-14 = 3 mg/kg q12h (6 mg/kg/day) Group 4: #1 = 2.5 mg/kg, #2-14 = 3 mg/kg q12h (6 mg/kg/day) Group 5: #1-14 = 3 mg/kg q12h (6 mg/kg/day)

Locations

Country	Name	City	State
Uganda	Kawempe National Referral Hospital	Kawempe

Sponsors (4)

Lead Sponsor	Collaborator
Pia Wintermark	Kawempe National Referral Hospital, Saint Francis Memorial Hospital, Walimu

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerable dose of sildenafil		within 30 days of drug administration
Secondary	Incidence of adverse events (Safety and Tolerability)	safety, assessed through the reporting of adverse events, such as death, hypotension, persistent pulmonary hypertension, altered hepatic function, seizures, intraventricular and/or intraparenchymal hemorrhage	within 30 days of drug administration
Secondary	Sildenafil concentrations		within 30 days of drug administration