Abstract
BACKGROUND AND OBJECTIVES: Despite the neonatal opioid withdrawal syndrome (NOWS) epidemic in the United States, evidence is limited for pharmacologic management when first-line opioid medications fail to control symptoms. The objective with this study was to evaluate outcomes of infants receiving secondary therapy with phenobarbital compared with clonidine, in combination with morphine, for the treatment of NOWS. METHODS: We performed a retrospective cohort study of infants with NOWS from 30 hospitals. The primary outcome measures were the length of hospital stay, duration of opioid treatment, and peak morphine dose. Outcomes were compared by group by using analysis of variance and multivariable linear regression controlling for relevant confounders. RESULTS: Of 563 infants with NOWS treated with morphine, 32% (n = 180) also received a secondary medication. Seventy-two received phenobarbital and 108 received clonidine. After adjustment for covariates, length of hospital stay was 10 days shorter, and, in some models, duration of morphine treatment was 7.5 days shorter in infants receiving phenobarbital compared with those receiving clonidine, with no difference in peak morphine dose. Infants were more likely to be discharged from the hospital on phenobarbital than clonidine (78% vs 29%, P,.0001). CONCLUSIONS: Among infants with NOWS receiving morphine and secondary therapy, those treated with phenobarbital had shorter length of hospital stay and shorter morphine treatment duration than clonidine-treated infants but were discharged from the hospital more often on secondary medication. Further investigation is warranted to determine if the benefits of shorter hospital stay and shorter duration of morphine therapy justify the possible neurodevelopmental consequences of phenobarbital use in infants with NOWS.
| Original language | English |
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| Article number | e2020017830 |
| Journal | Pediatrics |
| Volume | 147 |
| Issue number | 3 |
| DOIs | |
| State | Published - Mar 1 2021 |
Funding
FUNDING: The National Institutes of Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Center for Advancing Translational Sciences provided support for the Neonatal Research Network and the National Institutes of Health, Office of the Director, Environmental influences on Child Health Outcomes (ECHO) program provided support for the Institutional Development Award States Pediatric Clinical Trials Network. Although NICHD and National Institutes of Health ECHO staff had input into the study design, conduct, analysis, and manuscript drafting, the comments and views of the authors do not necessarily represent the views of NICHD or the ECHO program, the National Institutes of Health, the Department of Health and Human Services, or the US Government. Data were collected at participating sites of the NICHD Neonatal Research Network and participating sites of the ECHO Institutional Development Award States Pediatric Clinical Trials Network and transmitted to University of Arkansas for Medical Sciences, the Data Coordination and Operations Center for this study. Drs Jeannette Lee and Jessica Snowden (Data Coordination and Operations Center Principal Investigators) had full access to the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis. Funded by the National Institutes of Health (NIH).
| Funder number |
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| UG1OD024947 |