Advancing neonatal jaundice screening with mHealth: a mixed-methods randomised controlled feasibility study in a...

Neonatal jaundice is a common and usually harmless condition, but 10% of cases can progress to severe forms that can cause irreversible brain damage or death if undetected and untreated. The prevalence of severe cases is higher in resource-limited settings due to limited access to reliable detection methods among other contributing factors.

To assess the feasibility of implementing Picterus Jaundice Pro, a smartphone-based detection tool for neonatal jaundice, in a resource-limited Mexican healthcare setting.

A mixed-methods approach was employed, integrating a pragmatic randomised controlled trial (RCT) with qualitative insights from semi-structured interviews, all conducted within a feasibility framework. In the RCT, newborns were randomly assigned to screening by visual assessment alone (control) or visual assessment plus Picterus Jaundice Pro (intervention). Feasibility outcomes included RCT-derived measures - the proportion of positive screenings, successful referrals to emergency room (bilirubin ≥14.6 mg/dL [250 µmol/L]), jaundice management needed and jaundice management received. Recruitment capability, device practicality, integration, acceptability and protocol adherence were also assessed.

From January to June 2024, 542 newborns were included (273 control, 269 intervention). Compared with control, the intervention arm showed higher proportions (proportional difference [95% CI]) in positive screenings (0.299 [0.230 to 0.362]), successful referrals (0.112 [0.058 to 0.166]), jaundice management needed (0.045 [0.008 to 0.082]), and jaundice management received (0.038 [0.003 to 0.072]).Interviewed participants considered Picterus Jaundice Pro user-friendly and well-integrated into workflows. Despite high protocol adherence, incomplete referrals due to logistical barriers and low perceived risk by parents occurred in 11% of cases.

Implementing Picterus Jaundice Pro yielded encouraging improvements in screening practices, underscoring its potential to advance neonatal care. Addressing systemic barriers and raising awareness among parents and healthcare workers is crucial for maximizing impact.

NCT06073444.