Assessing Neurological Outcomes at One-Year Corrected Age in Preterms <=34 Weeks Gestation: Research Protocol for a Prospective Cohort Study

Preterm infants are at high risk of neurodevelopmental disorders, growth faltering, recurrent infections, re-hospitalization, and visual and auditory impairments. Despite the rising burden of preterm births, morbidities and mortalities in sub-Saharan Africa, data on neurodevelopmental and growth outcomes and survival during the first year of life remain scarce. This protocol aims to develop a comprehensive follow-up of care and early screening guidelines for this vulnerable population. The study will determine the prevalence of neurological disabilities at one year of corrected age (CA) among preterm infants ([&le;]34 weeks) discharged from two public hospitals in Nairobi, Kenya. It will identify maternal, neonatal, and clinical factors associated with neurological outcomes, characterize growth patterns and their relationship with neurodevelopmental outcomes and evaluate mortality risk at one year of CA. This prospective cohort will recruit 420 eligible preterm infants and follow them to one-year CA or death. Follow up assessments at 40 weeks post-menstrual age (PMA) or 2 weeks post discharge, at 3, 6, 9, and 12 months of CA will document growth, neurodevelopment using the Ages and Stages Questionnaire (ASQ), and sensory outcomes (hearing and visual). Near Infrared Spectroscopy (NIRS) will be performed at one year of CA. Longitudinal analyses using mixed-effects models and generalized estimating equations will examine growth and neurodevelopmental trajectories, while Cox proportional hazards models will assess mortality risk. The study is approved by the Kenyatta National Hospital-University of Nairobi Ethics (KNH-UoN) Committee, Reference Number P466/05/2023. This is the first cohort in Kenya to integrate neurological, growth, and sensory outcomes with advanced imaging in preterm infants. Findings will guide the development of an evidence-based care bundle for comprehensive follow-up and early intervention, potentially improving survival and long-term outcomes for this high-risk population, especially in low-resource settings.