Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal
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Published:2024-06-01
Issue:6
Volume:178
Page:525
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ISSN:2168-6203
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Container-title:JAMA Pediatrics
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language:en
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Short-container-title:JAMA Pediatr
Author:
Devlin Lori A.1, Hu Zhuopei2, Merhar Stephanie L.3, Ounpraseuth Songthip T.2, Simon Alan E.45, Lee Jeannette Y.2, Das Abhik6, Crawford Margaret M.6, Greenberg Rachel G.7, Smith P. Brian7, Higgins Rosemary D.89, Walsh Michele C.8, Rice Ward310, Paul David A.11, Maxwell Jessie R.12, Fung Camille M.13, Wright Tanner14, Ross Julie15, McAllister Jennifer M.3, Crowley Moira16, Shaikh Sophie K.17, Christ Lori18, Brown Jaime19, Riccio Julie20, Wong Ramsey Kara21, Braswell Erica F.22, Tucker Lauren23, McAlmon Karen24, Dummula Krishna25, Weiner Julie26, White Jessica R.27, Newman Sarah28, Snowden Jessica N.29, Young Leslie W.30, , Hubberd De Ann31, Edwards Kathy31, Whalen Bonny L.31, MacMillan Kate31, Pahl Adrienne31, Sheehan Desselle Farrah31, White Katie31, Hibbs Anna Marie31, Clarke Leslie31, Serio Kathy31, Kertesz Maria31, Rodriguez Ashley31, Driscoll Sarah31, Hammond Kim31, Hines Deborah31, Kish Patricia31, Schmidt Taylor31, Stepp Jennifer31, Jackson Jodi31, Scott Allie31, Brown Rochelle31, Smith Kari31, Rieper My31, Miner Carrie31, Ray Lynne31, Kowel Karen31, Reynolds Victoria31, Castellone Diana31, Mackley Amy31, Schibler Kurt31, Beiersdorfer Traci31, Grisby Cathy31, Kirker Kristin31, McKeown Katherine31, Loudermilk M. Katherine31, Carnohan Amy31, Froese Patti31, Haddix April31, Summe Virginia31, Chlon Clara31, Kunk Rita31, Hamilton Jen31, Moore Sadie31, Ziegelmeyer Angela31, Rolfes Lucy31, Schomaker Erica31, Strike Holly31, Harvey Sharon31, Richards Paula31, Simon Ashley31, Russell David31, Gleason Christine A.31, Allen Marilee C.31, Boyle Robert J.31, Clemons Traci31, D’Alton Mary E.31, Steinhorn Robin31, Weiner Steven J.31, Blaisdell Carol J.31, Wilson Archer Stephanie31, Amiotte Annette31, Santos Moara31, Taosaka Jill31, Neal Charles31, Atz Andrew M.31, Summer Andrea31, Amaya Michelle31, Freeman Mary31, Johnson Madison31, Sarraf Layla Al31, Ros-Demarize Rosemary31, Sánchez Pablo J.31, Slaughter Jonathan L.31, Benninger Kristen31, Luzader Patricia31, Marzec Laura31, DeSantis Brittany31, Small Kristi31, Newton Julia31, Purnell Jessica31, Reedy Rachel31, Hanlon Cory31, Naik Tanvi31, Knox Jordan31, Tallikar Aishwarya31, Cobe Chelsea31, Resetar Megan31, McCool Jacqueline31, Frailey Erin31, Jones Stephanie31, Williams Stacy31, Staton Taise31, Palmer Jacqueline N.31, Erner Jana L.31, Kovalcik Jason B.31, Keels Erin L.31, McCarty Teri31, Harris Katherine31, DeSpain Meagan31, Boyd Jackie31, Watson Sara31, Sullivan Jan31, Walsh Timothy31, Anderson Brianna31, Hahn Devon31, Madden Christi31, Nascimbeni Anne31, Wilson Shannon31, Gibson Theresa31, Karlin John31, Bann Carla M.31, O’Donnell Auman Jeanette31, Turner Eugene31, Smith Emily31, Bradley Lauren31, Trochinski Lillian31, Gabrio Jenna31, Leblond David31, Pickett James31, Newman Jamie E.31, Zaterka-Baxter Kristin M.31, Baack Michelle L.31, Hogden Laurie A.31, Elenkiwich Chelsey31, Henning Megan M.31, Van Muyden Sarah31, Martino Anna-Lisa31, Lutz Allison31, Nelson Jeralyn31, Schumacher Bette31, Brodkorb Aimee31, Pritchett Deborah31, Ford Kristen31, Howard Darla31, Orland Ryan31, Diles Monique31, Shuttleworth Kay L.31, Hubberd DeAnn E.31, Edwards Kathy D.31, Lloyd Sherry L.31, Banks-Johnson Catrice31, Robinson Patrina31, Griffith Melissa31, Slaughter Amie31, Kilkenny Teresa31, Foster Kristina31, Cross Morgan31, Gier Jessica31, Roberts Natalie31, Wadman Jessica31, Cathey Kathy31, Todd Jenna31, Fratesi Emily31, Malloch Lacy31, Alur Radha31, Majure Joseph Marc31, Walker Courtney31, Powers Catherine31, Annett Robert D.31, Wellman Rachel31, Miller Kerry31, Anderson-Berry Ann31, Raissy Hengameh31, Kong Alberta31, McCalmont Kate31, Sundquist Beauman Sandra31, Sanders Sarah31, Eichenwald Eric C.31, Mancini Toni31, Ziolkowski Kristina31, Dhawan Megan31, Gambacorta Mary Kay31, Pulsifer Allie31, Brant Marisa31, Schumacher Aida31, Gocial Sydney31, Azuma Kristen31, Quigley Elizabeth31, Zachritz Whitney31, Pastore Nicole31, Barber Jessica31, McDowell Abby31, Ferri Alissa31, Parga-Belinkie Joanna31, Guillet Ronnie31, Jensen Rosemary L.31, Kent Alison31, Scorsone Ann Marie31, Lakshminrusimha Satyan31, Hartley-McAndrews Michelle E.31, Li Emily31, Donato Jennifer31, McKee Kimberly G.31, D’Angio Carl31, Jones Rachel31, Terrano Dacia31, Solpietro Stephanie31, Brei Lisa31, Krokovich Lisa31, Hart Sema31, Pastore John31, Kern Ashley31, Mars Margaret31, Volker Patricia31, Mioneo Brady Annette31, Voelker Kelsey31, Horn Emily31, Moreland Melissa31, Kneusel Marcia31, Balakrishnan Maya31, Childres Jillian31, Hanniman Melissa31, White Rebecca31, Ohls Robin K.31, Baserga Mariana31, Muniyappa Bhanu31, Shakib Julie31, Rau Carrie A.31, Baker Shawna31, Coleman Kathie31, McGrath Kandace M.31, Petersen Brandy31, Waldvogel Jael31, Bracken Monika31, Ferrin Meredith31, DeSantis Holly31, Perkins Traci31, Loertscher Manndi C.31, McAlmon Karen31, Goldstein Justin31, Angelidou Asimenia31, Donahue Nancy31
Affiliation:
1. Department of Pediatrics, University of Louisville School of Medicine, Louisville, Kentucky 2. Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock 3. University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio 4. IDeA States Pediatric Clinical Trials Network (ISPCTN), Environmental Influences on Child Health Outcomes (ECHO) Program, National Institutes of Health, Rockville, Maryland 5. National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Maryland 6. Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina 7. Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina 8. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland 9. Office of Research and Sponsored Programs, Florida Gulf Coast University, Fort Myers 10. St Elizabeth Healthcare, Edgewood, Kentucky 11. Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, Delaware 12. University of New Mexico School of Medicine, Albuquerque 13. Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City 14. Department of Pediatrics, University of South Florida, Tampa 15. Medical University of South Carolina, Health Shawn Jenkins Children’s Hospital, Charleston 16. Department of Pediatrics, Rainbow Babies & Children’s Hospital, Case Western Reserve University, Cleveland, Ohio 17. Department of Pediatrics, Duke University, Durham, North Carolina 18. Hospital of the University of Pennsylvania, Philadelphia 19. Department of Pediatrics, Spartanburg Regional Medical Center, Spartanburg, South Carolina 20. University of Rochester School of Medicine and Dentistry, Rochester, New York 21. Kapiolani Medical Center for Women & Children, Honolulu, Hawaii 22. Department of Pediatrics, Nationwide Children’s Hospital, The Ohio State University College of Medicine, Columbus 23. Department of Pediatrics, University of Mississippi Medical Center, Jackson 24. Winchester Hospital, Winchester, Massachusetts 25. Department of Pediatrics, University of Kansas Medical Center, Kansas City, Missouri 26. Children’s Mercy Hospital, Kansas City, Missouri 27. Sanford Health, Sioux Falls, South Dakota 28. University of Nebraska Medical Center, Omaha 29. Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock 30. Larner College of Medicine at the University of Vermont, Burlington 31. for the Eunice Kennedy Shriver NICHD Neonatal Research Network and NIH Environmental Influences on Child Health Outcomes (ECHO) Program Institutional Development Award States Pediatric Clinical Trials Network
Abstract
ImportanceThe function-based eat, sleep, console (ESC) care approach substantially reduces the proportion of infants who receive pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS). This reduction has led to concerns for increased postnatal opioid exposure in infants who receive pharmacologic treatment. However, the effect of the ESC care approach on hospital outcomes for infants pharmacologically treated for NOWS is currently unknown.ObjectiveTo evaluate differences in opioid exposure and total length of hospital stay (LOS) for pharmacologically treated infants managed with the ESC care approach vs usual care with the Finnegan tool.Design, Setting, and ParticipantsThis post hoc subgroup analysis involved infants pharmacologically treated in ESC-NOW, a stepped-wedge cluster randomized clinical trial conducted at 26 US hospitals. Hospitals maintained pretrial practices for pharmacologic treatment, including opioid type, scheduled opioid dosing, and use of adjuvant medications. Infants were born at 36 weeks’ gestation or later, had evidence of antenatal opioid exposure, and received opioid treatment for NOWS between September 2020 and March 2022. Data were analyzed from November 2022 to January 2024.ExposureOpioid treatment for NOWS and the ESC care approach.Main Outcomes and MeasuresFor each outcome (total opioid exposure, peak opioid dose, time from birth to initiation of first opioid dose, length of opioid treatment, and LOS), we used generalized linear mixed models to adjust for the stepped-wedge design and maternal and infant characteristics.ResultsIn the ESC-NOW trial, 463 of 1305 infants were pharmacologically treated (143/603 [23.7%] in the ESC care approach group and 320/702 [45.6%] in the usual care group). Mean total opioid exposure was lower in the ESC care approach group with an absolute difference of 4.1 morphine milligram equivalents per kilogram (MME/kg) (95% CI, 1.3-7.0) when compared with usual care (4.8 MME/kg vs 8.9 MME/kg, respectively; P = .001). Mean time from birth to initiation of pharmacologic treatment was 22.4 hours (95% CI, 7.1-37.7) longer with the ESC care approach vs usual care (75.4 vs 53.0 hours, respectively; P = .002). No significant difference in mean peak opioid dose was observed between groups (ESC care approach, 0.147 MME/kg, vs usual care, 0.126 MME/kg). The mean length of treatment was 6.3 days shorter (95% CI, 3.0-9.6) in the ESC care approach group vs usual care group (11.8 vs 18.1 days, respectively; P < .001), and mean LOS was 6.2 days shorter (95% CI, 3.0-9.4) with the ESC care approach than with usual care (16.7 vs 22.9 days, respectively; P < .001).Conclusion and RelevanceWhen compared with usual care, the ESC care approach was associated with less opioid exposure and shorter LOS for infants pharmacologically treated for NOWS. The ESC care approach was not associated with a higher peak opioid dose, although pharmacologic treatment was typically initiated later.Trial RegistrationClinicalTrials.gov Identifier: NCT04057820
Publisher
American Medical Association (AMA)
Reference37 articles.
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