Birth AsphyxiaPhase 1SANE-UgandaNCT05275725
Finding Solutions to Thrive After Birth Asphyxia in Africa
A Phase 1 study testing Sildenafil in people with Birth Asphyxia, run by Pia Wintermark at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 0 days to 18 months
- Conditions the study is for
- Birth Asphyxia
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jul 2022to 31 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Finding Solutions to Thrive After Birth Asphyxia in Africa: An Open-label Dose-finding Clinical Trial (Phase Ib Study)
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.
- Conditions
- Birth Asphyxia
- Being tested
- Sildenafil
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil | Experimental | Not described Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable dose of sildenafil
Measured: within 30 days of drug administration
Secondary outcomes (2)
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
Measured: within 30 days of drug administration
Sildenafil concentrations
Measured: within 30 days of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start1 Jul 2022
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birth AsphyxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase Ib open-label single-arm dose-finding clinical trial
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pia Wintermark
- Sponsor type
- University, hospital or other
- Collaborators
- Kawempe National Referral Hospital, WVU Medicine Thomas Hospitals, Walimu
- Responsible party
- Sponsor-investigator, Pia Wintermark, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275725
- Sponsor's protocol ID
- SANE-Uganda
- Acronym
- SANE-Uganda
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Solutions to Thrive After Birth Asphyxia in Africa: An Open-label Dose-finding Clinical Trial (Phase Ib Study)
- ClinicalTrials.gov ID
- NCT05275725
- Acronym / sponsor ID
- SANE-Uganda / SANE-Uganda
- Conditions
- Birth Asphyxia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pia WintermarkUniversity, hospital or other
- Collaborators
- Kawempe National Referral Hospital, WVU Medicine Thomas Hospitals, Walimu
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase Ib open-label single-arm dose-finding clinical trial
| Arm | Type | Receives |
|---|---|---|
| Sildenafil | Experimental | Drug: Sildenafil |
Who may qualify
- Ages
- 0 days to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SildenafilDose 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) | Drug | Sildenafil |
Primary outcome
Maximum tolerable dose of sildenafil
Time frame: within 30 days of drug administration
2 secondary outcomes
Incidence of adverse events (Safety and Tolerability)
Time frame: within 30 days of drug administration
Sildenafil concentrations
Time frame: within 30 days of drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. No individual participant data sharing
Related trials for Birth Asphyxia
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sildenafil in people with Birth Asphyxia, run by Pia Wintermark at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerable dose of sildenafil (time frame: within 30 days of drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.