Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

doi:10.1186/s13063-022-06445-z

. 2022 Aug 9;23(1):638.

doi: 10.1186/s13063-022-06445-z.

Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

Leslie W Young¹, Songthip Ounpraseuth², Stephanie L Merhar³, Alan E Simon⁴, Abhik Das⁵, Rachel G Greenberg⁶, Rosemary D Higgins⁷, Jeannette Lee⁸, Brenda B Poindexter⁹, P Brian Smith⁶, Michele Walsh¹⁰, Jessica Snowden¹¹, Lori A Devlin¹²; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network and the NIH Environmental influences on Child Health Outcomes (ECHO) Program Institutional Development Awards States Pediatric Clinical Trials Network

Affiliations

¹ Department of Pediatrics, Larner College of Medicine at the University of Vermont, 111 Colchester Ave Smith 5, Burlington, VT, 05401, USA. Leslie.Young@uvmhealth.org.
² University of Arkansas for Medical Sciences, 4301 W. Markham St., Little Rock, AR, 72205, USA.
³ Department of Pediatrics, University of Cincinnati, 3333 Burnet Ave ML7009, Cincinnati, OH, 45229, USA.
⁴ Environmental Influences on Child Health Outcomes (ECHO) Program, Office of the Director, the National Institutes of Health, Three White Flint North 11601 Landsdown Street, Office 3D16, North Bethesda, MD, 20852, USA.
⁵ RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.
⁶ Duke University School of Medicine Duke Clinical Research Institute, 300 W. Morgan St, Durham, NC, 27701, USA.
⁷ College of Health and Human Services George Mason University, 4400 University Drive 2G7 Peterson Family Health Science Hall Room 5415 Fairfax, Virginia, 22030, USA.
⁸ University of Arkansas for Medical Sciences, 4301 West Markham, #781 COPH Room 3234, Little Rock, Arkansas, 72205-7199, USA.
⁹ Emory University School of Medicine, 2015 Uppergate Dr. NE, Suite 304, Atlanta, GA, 30322, USA.
¹⁰ Pregnancy and Perinatology Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710 Rockledge Dr. Wing B, Rm2321-D, Bethesda, MD, 20892-7002, USA.
¹¹ Arkansas Children's Research Institute, University of Arkansas for Medical Sciences, 13 Children's Way, ACRI Slot 512-35, Little Rock, AR, 72202, USA.
¹² Department of Pediatrics, University of Louisville School of Medicine, 571 South Floyd Street Suite 342, Louisville, KY, 40202, USA.

PMID: 35945598
PMCID: PMC9361241
DOI: 10.1186/s13063-022-06445-z

Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

Leslie W Young et al. Trials. 2022.

. 2022 Aug 9;23(1):638.

doi: 10.1186/s13063-022-06445-z.

Authors

Affiliations

¹ Department of Pediatrics, Larner College of Medicine at the University of Vermont, 111 Colchester Ave Smith 5, Burlington, VT, 05401, USA. Leslie.Young@uvmhealth.org.
² University of Arkansas for Medical Sciences, 4301 W. Markham St., Little Rock, AR, 72205, USA.
³ Department of Pediatrics, University of Cincinnati, 3333 Burnet Ave ML7009, Cincinnati, OH, 45229, USA.
⁴ Environmental Influences on Child Health Outcomes (ECHO) Program, Office of the Director, the National Institutes of Health, Three White Flint North 11601 Landsdown Street, Office 3D16, North Bethesda, MD, 20852, USA.
⁵ RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA.
⁶ Duke University School of Medicine Duke Clinical Research Institute, 300 W. Morgan St, Durham, NC, 27701, USA.
⁷ College of Health and Human Services George Mason University, 4400 University Drive 2G7 Peterson Family Health Science Hall Room 5415 Fairfax, Virginia, 22030, USA.
⁸ University of Arkansas for Medical Sciences, 4301 West Markham, #781 COPH Room 3234, Little Rock, Arkansas, 72205-7199, USA.
⁹ Emory University School of Medicine, 2015 Uppergate Dr. NE, Suite 304, Atlanta, GA, 30322, USA.
¹⁰ Pregnancy and Perinatology Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710 Rockledge Dr. Wing B, Rm2321-D, Bethesda, MD, 20892-7002, USA.
¹¹ Arkansas Children's Research Institute, University of Arkansas for Medical Sciences, 13 Children's Way, ACRI Slot 512-35, Little Rock, AR, 72202, USA.
¹² Department of Pediatrics, University of Louisville School of Medicine, 571 South Floyd Street Suite 342, Louisville, KY, 40202, USA.

PMID: 35945598
PMCID: PMC9361241
DOI: 10.1186/s13063-022-06445-z

No abstract available

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Conflict of interest statement

The authors declare that they have no completing interests.

Figures

**Fig. 1**
Screening and enrollment procedures. *The site research team may obtain consent for the long-term follow-up portion of the study at any point during the hospital stay for infants who meet the trial’s inclusion criteria. To optimize recruitment it will permissible to obtain initial consent up to one month after discharge

See this image and copyright information in PMC

Cited by

Advances in the Care of Infants With Prenatal Opioid Exposure and Neonatal Opioid Withdrawal Syndrome.
Mascarenhas M, Wachman EM, Chandra I, Xue R, Sarathy L, Schiff DM. Mascarenhas M, et al. Pediatrics. 2024 Jan 1;153(2):e2023062871. doi: 10.1542/peds.2023-062871. Pediatrics. 2024. PMID: 38178779 Free PMC article. Review.
Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal.
Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Telang S, Fung CM, Wright T, Reynolds AM, Hahn DW, Ross J, McAllister JM, Crowley M, Shaikh SK, Puopolo KM, Christ L, Brown J, Riccio J, Wong Ramsey K, Akshatha, Braswell EF, Tucker L, McAlmon KR, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Devlin LA; ACT NOW Collaborative. Young LW, et al. N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30. N Engl J Med. 2023. PMID: 37125831 Free PMC article. Clinical Trial.
Neonatal opioid withdrawal syndrome: a review of the science and a look toward the use of buprenorphine for affected infants.
Devlin LA, Young LW, Kraft WK, Wachman EM, Czynski A, Merhar SL, Winhusen T, Jones HE, Poindexter BB, Wakschlag LS, Salisbury AL, Matthews AG, Davis JM. Devlin LA, et al. J Perinatol. 2022 Mar;42(3):300-306. doi: 10.1038/s41372-021-01206-3. Epub 2021 Sep 23. J Perinatol. 2022. PMID: 34556799 Free PMC article. Review.
Overview of the neonatal research network: History, contributions, challenges, and future.
Watterberg KL, Carlo WA, Brion LP, Cotten CM, Higgins RD. Watterberg KL, et al. Semin Perinatol. 2022 Nov;46(7):151634. doi: 10.1016/j.semperi.2022.151634. Epub 2022 Jun 10. Semin Perinatol. 2022. PMID: 35786518 Free PMC article. Review.

References

1. Patrick SW, Davis MM, Lehman CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015;35(8):667. - PubMed
1. Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012;307(18):1934–1940. - PubMed
1. Tolia VN, Patrick SW, Bennett MM, Murthy K, Sousa J, Smith PB, et al. Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs. New Engl J Med. 2015;372(22):2118–2126. - PubMed
1. Hudak ML, Tan RC, Committee On D, Committee On F, Newborn, American Academy of P Neonatal drug withdrawal. Pediatrics. 2012;129(2):e540–e560. - PubMed
1. Reddy UM, Davis JM, Ren Z, Greene MF. Opioid Use in Pregnancy NAS, Childhood Outcomes Workshop Invited S. Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes: Executive Summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, American College of Obstetricians and Gynecologists, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, Centers for Disease Control and Prevention, and the March of Dimes Foundation. Obstet Gynecol. 2017;130(1):10–28. - PMC - PubMed

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[1] Patrick SW, Davis MM, Lehman CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015;35(8):667. - PubMed

[2] Patrick SW, Davis MM, Lehman CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012. J Perinatol. 2015;35(8):667. - PubMed

[3] Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012;307(18):1934–1940. - PubMed

[4] Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012;307(18):1934–1940. - PubMed

[5] Tolia VN, Patrick SW, Bennett MM, Murthy K, Sousa J, Smith PB, et al. Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs. New Engl J Med. 2015;372(22):2118–2126. - PubMed

[6] Tolia VN, Patrick SW, Bennett MM, Murthy K, Sousa J, Smith PB, et al. Increasing incidence of the neonatal abstinence syndrome in U.S. neonatal ICUs. New Engl J Med. 2015;372(22):2118–2126. - PubMed

[7] Hudak ML, Tan RC, Committee On D, Committee On F, Newborn, American Academy of P Neonatal drug withdrawal. Pediatrics. 2012;129(2):e540–e560. - PubMed

[8] Hudak ML, Tan RC, Committee On D, Committee On F, Newborn, American Academy of P Neonatal drug withdrawal. Pediatrics. 2012;129(2):e540–e560. - PubMed

[9] Reddy UM, Davis JM, Ren Z, Greene MF. Opioid Use in Pregnancy NAS, Childhood Outcomes Workshop Invited S. Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes: Executive Summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, American College of Obstetricians and Gynecologists, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, Centers for Disease Control and Prevention, and the March of Dimes Foundation. Obstet Gynecol. 2017;130(1):10–28. - PMC - PubMed

[10] Reddy UM, Davis JM, Ren Z, Greene MF. Opioid Use in Pregnancy NAS, Childhood Outcomes Workshop Invited S. Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes: Executive Summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, American College of Obstetricians and Gynecologists, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, Centers for Disease Control and Prevention, and the March of Dimes Foundation. Obstet Gynecol. 2017;130(1):10–28. - PMC - PubMed

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Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

Affiliations

Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

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