BACKGROUND AND AIMS: Our understanding of the long-term safety of prenatal exposure to opioid maintenance treatment (OMT) is insufficient. We compared childhood morbidity (0-3 years) between OMT-exposed and relevant comparison groups. DESIGN: Nation-wide, registry-based cohort study. Registries on reproductive health, addiction treatment, hospitalization and death were linked using identification numbers. SETTING: The Czech Republic (2000-14). PARTICIPANTS: Children with different prenatal exposure: (i) mother in OMT during pregnancy (OMT; n = 218), (ii) mother discontinued OMT before pregnancy (OMT-D; n = 55), (iii) mother with opioid use disorder, but not in OMT during pregnancy (OUD; n = 85) and (iv) mother in the general population (GP) (n = 1 238 452) MEASUREMENTS: Episodes of hospitalization were observed as outcomes. Information on in-patient contacts, length of stay and diagnoses (International Classification of Diseases version 10) were assessed. Binary logistic regressions were conducted to estimate the associations between OMT exposure and the outcomes, crude and adjusted for the socio-economic status and smoking. FINDINGS: No significant differences were found in the overall proportion of hospitalization among OMT-exposed children, children of OMT-D and children of women with OUD [54.1%, 95% confidence interval (CI) = 47.3-60.1%; 47.3%, 95% CI = 33.9-61.1%; 51.8%, 95% CI = 40.7%-62.6%], while the proportion was significantly lower (35.8%, 95% CI = 35.7-35.8%) in the GP. There were no significant differences in risk of specific diagnoses between OMT-exposed children, children of OMT-D and children of women with OUD. In the adjusted analyses, differences between OMT-exposed and children in the GP were still present for infections and parasitic diseases (OR = 2.0, 95% CI = 1.4-2.7), diseases of the digestive system (OR = 1.7, 95% CI = 1.2-2.6) and diseases of the skin and subcutaneous tissue (OR = 1.9, 95% CI = 1.2-3.2). CONCLUSION: This study did not find clear evidence for an increase in risk of morbidity during the first 3 years of life in children with prenatal opioid maintenance treatment exposure compared with children of women who discontinued such treatment before pregnancy or suffered from opioid use disorder without this treatment. Compared the general population, there appears to be an increased risk of hospitalizations for infectious, gastrointestinal and skin diseases.

Department of Addictology 1st Faculty of Medicine Charles University Czech Republic

Department of Addictology 1st Faculty of Medicine Charles University Czech Republic Institute of Health Information and Statistics of the Czech Republic

Department of Addictology 1st Faculty of Medicine Charles University Czech Republic National Monitoring Centre for Drugs and Addiction Prague Czech Republic

Norwegian institute of Public Health Oslo Norway

Norwegian institute of Public Health Oslo Norway Norwegian Centre for Addiction Research at the University of Oslo Norway

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