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

Abstract 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 (≤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. Competing Interest Statement The authors have declared no competing interest. Funding Statement The author(s) received no specific funding for this work. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study has been approved by KNH-UoN ethics research committee Reference Number P466/05/2023 and the Mbagathi County Referral Hospital. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Footnotes P.O. Box 19676 – 00202, NAIROBI., dept-paediatrics{at}uonbi.ac.ke P.O. Box 30197 – 00100, NAIROBI., dept-humananat{at}uonbi.ac.ke P.O. Box 43640 – 00100 NAIROBI., info{at}kemri-wellcome.org Email Contacts: Dr. Florence Murila - fmurila{at}gmail.com, Dr. Jalemba Aluvaala - jaluvaala{at}uonbi.ac.ke, Prof. Fred Were - frednwere{at}gmail.com, Prof. Moses Obimbo - moses.obimbo{at}uonbi.ac.ke Data Availability No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.