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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05275725
Other study ID # SANE-Uganda
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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