Background: Neonatal jaundice affects over 60% of newborns globally, with the highest burden in low- and middle-income countries. In Uganda, neonatal jaundice affects more than 21% of newborns and contributes to a mortality of 16.6% within the first seven days of life. While phototherapy is a proven, effective treatment, over 5.7 million newborns worldwide lack access due to high costs, limited capacity, bulky equipment, and unreliable electricity supply. These gaps result in preventable complications such as hearing loss, neurodevelopmental delay, and death.
Objective: The Photo-kabada Trial aims to compare the safety and efficacy of the locally developed Photo-Kabada phototherapy device with routinely used phototherapy machines in treating neonatal jaundice.
Methods: This is a Phase I, open-label, parallel, randomized controlled trial conducted at Mbarara Regional Referral Hospital and Holy Innocents Children’s Hospital in Uganda. Thirty neonates with uncomplicated unconjugated hyperbilirubinemia (≥37 weeks gestation) will be randomized 1:1 to receive phototherapy using either the Photo-Kabada device or the standard Firefly double-sided LED phototherapy machine. The intervention period is 12 hours, with follow-up to 24 hours. Primary outcomes include safety (adverse events within 12 hours) and efficacy (reduction in total serum bilirubin by 1–2 mg/dL within 6 hours). Secondary outcomes assess bilirubin kinetics, clinical response, feasibility, and user acceptability.
Trial Implementing Contract Research Organization (CRO): Soar Research Foundation / SRF Research and Training Centres, Mbarara, Uganda
Principal Investigator: Dr Atwine Daniel (PhD, MPhil, MPH, MD)
Sponsor: Photo-Kabada Company Limited.
Funder: Villgro-Africa
Current status: Completed regulatory approvals, starting implementation
Expected completion date: December 2026