학술논문
Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial.
Document Type
Academic Journal
Author
Devlin LA; Department of Pediatrics, University of Louisville School of Medicine, Louisville, Kentucky.; Hu Z; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock.; Merhar SL; University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.; Ounpraseuth ST; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock.; Simon AE; IDeA States Pediatric Clinical Trials Network (ISPCTN), Environmental Influences on Child Health Outcomes (ECHO) Program, National Institutes of Health, Rockville, Maryland.; National Center for Health Statistics, Centers for Disease Control and Prevention, Hyattsville, Maryland.; Lee JY; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock.; Das A; Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina.; Crawford MM; Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina.; Greenberg RG; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Smith PB; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.; Office of Research and Sponsored Programs, Florida Gulf Coast University, Fort Myers.; Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.; Rice W; University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.; St Elizabeth Healthcare, Edgewood, Kentucky.; Paul DA; Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, Delaware.; Maxwell JR; University of New Mexico School of Medicine, Albuquerque.; Fung CM; Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City.; Wright T; Department of Pediatrics, University of South Florida, Tampa.; Ross J; Medical University of South Carolina, Health Shawn Jenkins Children's Hospital, Charleston.; McAllister JM; University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.; Crowley M; Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, Ohio.; Shaikh SK; Department of Pediatrics, Duke University, Durham, North Carolina.; Christ L; Hospital of the University of Pennsylvania, Philadelphia.; Brown J; Department of Pediatrics, Spartanburg Regional Medical Center, Spartanburg, South Carolina.; Riccio J; University of Rochester School of Medicine and Dentistry, Rochester, New York.; Wong Ramsey K; Kapiolani Medical Center for Women & Children, Honolulu, Hawaii.; Braswell EF; Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus.; Tucker L; Department of Pediatrics, University of Mississippi Medical Center, Jackson.; McAlmon K; Winchester Hospital, Winchester, Massachusetts.; Dummula K; Department of Pediatrics, University of Kansas Medical Center, Kansas City, Missouri.; Weiner J; Children's Mercy Hospital, Kansas City, Missouri.; White JR; Sanford Health, Sioux Falls, South Dakota.; Newman S; University of Nebraska Medical Center, Omaha.; Snowden JN; Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock.; Young LW; Larner College of Medicine at the University of Vermont, Burlington.
Source
Publisher: American Medical Association Country of Publication: United States NLM ID: 101589544 Publication Model: Print Cited Medium: Internet ISSN: 2168-6211 (Electronic) Linking ISSN: 21686203 NLM ISO Abbreviation: JAMA Pediatr Subsets: MEDLINE
Subject
Language
English
Abstract
Importance: The 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.
Objective: To 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 Participants: This 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.
Exposure: Opioid treatment for NOWS and the ESC care approach.
Main Outcomes and Measures: For 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.
Results: In 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 Relevance: When 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 Registration: ClinicalTrials.gov Identifier: NCT04057820.
Objective: To 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 Participants: This 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.
Exposure: Opioid treatment for NOWS and the ESC care approach.
Main Outcomes and Measures: For 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.
Results: In 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 Relevance: When 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 Registration: ClinicalTrials.gov Identifier: NCT04057820.