One-Year Neurodevelopmental Outcomes After Neonatal Opioid Withdrawal Syndrome: A Prospective Cohort Study

Abstract

Purpose: The aims of this study were, in a cohort of children with neonatal opioid withdrawal syndrome (NOWS), (a) to report 1-year neurodevelopmental outcomes and specifically characterize speech, language, and hearing outcomes and (b) to report the prevalence of cleft lip and/or cleft palate.

Method: This prospective observational cohort study includes newborns with confirmed in utero opioid exposure who received pharmacological treatment for NOWS. During 1-year-old developmental visits, we administered standardized assessments (Bayley Scales of Infant and Toddler Development-Third Edition [Bayley-III] or Developmental Assessment of Young Children-Second Edition [DAYC-2]-due to COVID-19 restrictions). We compared Bayley-III scores to standardized population means using one-sample z tests. We report estimates, 95% confidence intervals, and two-sided p values.

Results: We enrolled 202 infants (October 2018 to March 2020). Follow-up at 1-year was 80%. Infants with NOWS had lower Bayley-III scores at 1 year compared to published norms for cognitive, language, and motor domains. One infant with NOWS was diagnosed with isolated cleft palate and Pierre Robin sequence. All infants passed the newborn hearing screen, and 7.5% had a formal hearing evaluation after neonatal intensive care unit discharge, with 40% having abnormal or inconclusive results; middle ear effusion was the leading cause of abnormal hearing (66.7%). Ten percent of children received a speech-language pathology referral prior to 2 years of age. Infants born to mothers with mental health conditions were more likely to have Bayley-III or DAYC-2 scores below 95 in language or motor domains.

Conclusions: Infants with pharmacologically treated NOWS have significantly lower cognitive, language, and motor scores on standardized developmental testing compared to population means at 1 year of age. Early speech-language pathology referral is frequently necessary to promote optimal development in this population.

Supplemental material: https://doi.org/10.23641/asha.20044403.

Figure 1.

Derivation of the neonatal opioid withdrawal syndrome study cohort. We approached 244 eligible patients in the neonatal intensive care unit (NICU) or NICU Follow-Up Clinic. We enrolled 202 infants from October 2018 to March 2020. One hundred sixty-one infants in the prospective cohort (80%) completed at least a partial 1-year developmental visit. Bayley-III = Bayley Scales of Infant and Toddler Development–Third Edition; DAYC-2 = Developmental Assessment of Young Children–Second Edition; NOWS = neonatal opioid withdrawal syndrome.

Figure 2.

Neonatal opioid withdrawal syndrome cohort hearing assessments. The Early Hearing Detection and Intervention (EHDI) guidelines from the Joint Committee on Infant Hearing (JCIH) state that children should undergo hearing screening by 1 month of age, receive audiological testing and diagnosis by 3 months if testing indicates hearing impairment, and receive intervention by 6 months (EHDI 1–3–6 goals in red). Updated guidelines (2019 position statement) recommend a more aggressive 1–2–3 month timeline for states that consistently meet the 1–3–6 goals. All infants in this prospective cohort received and passed the newborn hearing screening (NBHS). Audiology referrals (n = 15, blue boxes) trigged electrophysiological and behavioral evaluations. Regardless of their audiological status, all patients referred for hearing evaluations were recommended follow-up with ear specific audiometric testing at 3 years of age (JCIH, 2019). ABR = auditory brainstem response; MEE = middle ear effusion; NOWS = neonatal opioid withdrawal syndrome; OAE = otoacoustic emissions; Tymp = tympanometry; VRA = visual reinforcement audiometry.