Process, outcomes and feasibility of implementing universal newborn screening programme in Sri Lanka.

The universal newborn screening detects clinically occult but potentially serious conditions, enabling timely treatment to reduce child morbidity and mortality. The World Health Organisation recommends incorporating universal newborn screening into routine newborn care. In early 2025, Sri Lanka launched a universal newborn screening package including screening for eye abnormalities, congenital hypothyroidism, critical congenital heart diseases and hearing impairment in five pilot hospitals. Here, we aim to describe the process, outcomes, and technical and operational feasibility of implementing the universal newborn screening package in Sri Lanka. A descriptive study was conducted in five hospitals that piloted the universal newborn screening package in Sri Lanka from January to March 2025. All neonates born during the study period were recruited. Data on the screening process were obtained from maternal interviews and patient records. Telephone interviews were done 4-6 weeks post-discharge to capture screening outcomes. Neonates who had abnormal results of the screening tests were identified as 'Refer' for the test. A total of 3860 newborns (males-51.0%) were recruited. Eye screening was performed in > 99% of neonates, with 76 (1.9%) being 'Refer' predominantly (74/76) due to the presence of risk factors. The screening rate for congenital hypothyroidism was 99.8%, which detected six (0.15%) with congenital hypothyroidism. Pulse oximetry screening was performed in 98.5%, of which eight (0.2%) were 'Refer' and one subsequently confirmed to have a critical congenital heart disease. Overall, 79.1% of neonates underwent hearing screening, of which 325 (10.6%) were 'Refer' in the first test, and 20 were 'Refer' in the second test and referred for further evaluation. The pilot implementation of the Universal Newborn Screening package in Sri Lanka demonstrated high coverage exceeding 98% for screening of congenital hypothyroidism, critical congenital heart disease, and eye abnormalities, highlighting operational feasibility. In contrast, screening for hearing impairment remained suboptimal, largely attributable to logistical and system-level challenges. The congenital hypothyroidism screening detected six (0.15%) cases, and pulse oximetry screening detected one with a critical congenital heart disease. These findings suggest that universal newborn screening is a feasible and potentially sustainable intervention that can be effectively integrated into the existing health system in Sri Lanka.