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Active, Not Recruiting

NCT Number: NCT05275725

Finding Solutions to Thrive After Birth Asphyxia in Africa

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Birth Asphyxia Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

0 day–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kawempe National Referral Hospital

Kawempe, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

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 outcomes

  1. Maximum tolerable dose of sildenafil

    Time frame: within 30 days of drug administration

Secondary outcomes

  1. Incidence of adverse events (Safety and Tolerability)

    Time frame: within 30 days of drug administration

    safety, assessed through the reporting of adverse events, such as death, hypotension, persistent pulmonary hypertension, altered hepatic function, seizures, intraventricular and/or intraparenchymal hemorrhage

  2. Sildenafil concentrations

    Time frame: within 30 days of drug administration

Sponsors and collaborators

Lead sponsor

Pia Wintermark

Other

Collaborators

  • Kawempe National Referral Hospital
  • Saint Francis Hospital
  • Walimu

Registry information

Official study title

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

Acronym: SANE-Uganda

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2022
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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