Background: Heroin addiction is a universal encumbrance. Currently in Kenya, the estimate of heroin users is between 18,000 to 33,000. The use of heroin during pregnancy has been associated with high incidence of prematurity, low birth weight, higher number of neonates born experiencing Neonatal Abstinence Syndrome (NAS) and neonatal mortality. Globally, there has been marked improvement in the neonatal outcomes since the introduction of methadone as a gold standard treatment of heroin addiction. Objective: To determine the clinical outcomes of neonates born to mothers on Opioid Substitution Therapy (OST) with methadone in Kenya. Utility: This is the first program evaluation of the newborn outcomes among babies of women on OST with methadone in Kenya and will form the basis for future program planning and improvement of the current case-management plans. Methodology: This was a retrospective cohort study. It was a countrywide multicenter study carried out at six of the largest Medication assisted treatment (MAT) clinics in Kenya. The study population was mothers on opioid substitution therapy (OST) with methadone and their neonates born in the period 1st January 2015 to 31st December 2019. Data collection: A predesigned stratified data collection tool was used in collecting relevant data in files of women who met the inclusion criteria. There was no sampling done due to the limited number of infants born in this programme. Data obtained from study population through data collection forms were checked for completeness and accuracy and entered into a password protected database. Data analysis: The data collected was entered into a Microsoft Excel spreadsheet, cleaned and transferred to STATA version 11.2 for analysis. Descriptive statistics of the study population were summarized as medians and ranges for continuous data and proportions.

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