Finding Solutions to Thrive After Birth Asphyxia in Africa (SANE-Uganda)
Primary Purpose
Birth Asphyxia
Status
Recruiting
Phase
Phase 1
Locations
Uganda
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
About this trial
This is an interventional treatment trial for Birth Asphyxia
Eligibility Criteria
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
Sites / Locations
- Kawempe National Referral HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sildenafil
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerable dose of sildenafil
Secondary Outcome Measures
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
Sildenafil concentrations
Full Information
NCT ID
NCT05275725
First Posted
February 8, 2022
Last Updated
October 16, 2023
Sponsor
Pia Wintermark
Collaborators
Kawempe National Referral Hospital, Saint Francis Memorial Hospital, Walimu
1. Study Identification
Unique Protocol Identification Number
NCT05275725
Brief Title
Finding Solutions to Thrive After Birth Asphyxia in Africa
Acronym
SANE-Uganda
Official Title
Finding Solutions to Thrive After Birth Asphyxia in Africa: An Open-label Dose-finding Clinical Trial (Phase Ib Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pia Wintermark
Collaborators
Kawempe National Referral Hospital, Saint Francis Memorial Hospital, Walimu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Asphyxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Phase Ib open-label single-arm dose-finding clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
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)
Primary Outcome Measure Information:
Title
Maximum tolerable dose of sildenafil
Time Frame
within 30 days of drug administration
Secondary Outcome Measure Information:
Title
Incidence of adverse events (Safety and Tolerability)
Description
safety, assessed through the reporting of adverse events, such as death, hypotension, persistent pulmonary hypertension, altered hepatic function, seizures, intraventricular and/or intraparenchymal hemorrhage
Time Frame
within 30 days of drug administration
Title
Sildenafil concentrations
Time Frame
within 30 days of drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pia Wintermark, MD
Phone
514-412-4452
Email
pia.wintermark@mcgill.ca
Facility Information:
Facility Name
Kawempe National Referral Hospital
City
Kawempe
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorraine Oriokot, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data sharing
Learn more about this trial
Finding Solutions to Thrive After Birth Asphyxia in Africa
We'll reach out to this number within 24 hrs