Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach

NCT04057820 | Completed Results DMC

• 2 other identifiers: ACTNOW-013U2COD023375-06S1
• Study Type: interventional
• Target: 1,305
• Locations: 1 country
• Sites: 26

Brief Summary

The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.

Conditions

Neonatal Opiate Withdrawal Syndrome

Keywords

NOWS

Outcome Measures

Primary Outcomes (1)

• Time From Birth Until Medically Ready for Discharge

  The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density.

  from date of birth until hospital discharge or 1 year whichever comes first

Secondary Outcomes (11)

• Did Infant Receive Opioid Replacement Therapy (Yes/no)

  From date of birth until hospital discharge or 1 year whichever comes first

• Total Dose of Opioid Replacement Therapy Infant Received

  From date of birth until hospital discharge or 1 year whichever comes first

• Time Until Initiation of Opioid Replacement

  From date of birth until hospital discharge or 1 year whichever comes first

• Receipt of Adjuvant Therapy

  from date of birth until hospital discharge or 1 year whichever comes first

• Maximum Percent Change in Weight During Initial Birth Hospitalization

  from date of birth until hospital discharge or 1 year whichever comes first

Study Arms (2)

Usual care, Finnegan Neonatal Abstinence Scoring Tool

ACTIVE COMPARATOR

Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)

Other: Finnegan Neonatal Abstinence Scoring Tool

Eat, Sleep, Console care tool

ACTIVE COMPARATOR

New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool

Other: Eat, Sleep, Console (ESC) care tool

Interventions

Finnegan Neonatal Abstinence Scoring Tool OTHER

The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.

Also known as: FNAST

Usual care, Finnegan Neonatal Abstinence Scoring Tool

Eat, Sleep, Console (ESC) care tool OTHER

The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.

Also known as: ESC

Eat, Sleep, Console care tool

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:
• Maternal history of prenatal opioid use
• Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
• Infant toxicology screen positive for opioids during the initial hospital stay

You may not qualify if:

• \. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at \>60 hours of life or treated with opioids for NOWS at the transferring hospital

Sponsors & Collaborators

• Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program: lead
• National Institutes of Health (NIH): collaborator

Study Sites (26)

Chistiana Care Health Systems

Newark, Delaware, 19718, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Kapiolani Hospital

Honolulu, Hawaii, 96826, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Shawnee Mission Medical Center

Shawnee Mission, Kansas, 66204, United States

Location

St. Elizabeth Healthcare/CCHMC

Edgewood, Kentucky, 41017, United States

Location

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Tulane University School of Medicine

Metairie, Louisiana, 70001, United States

Location

Winchester Hospital

Winchester, Massachusetts, 01890, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-1205, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Duke Hospital

Durham, North Carolina, 27710, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57105, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84108, United States

Location

Related Publications (4)

• Beauman SGS, Hu Z, Rice W, Devlin L, Merhar SL, Fung CM, Brown J, Osman A, Pahl A, Ramsey KW, Whalen B, MacMillan KDL, Ounpraseuth ST, Das A, Crawford MM, Trochinski L, Greenberg RG, Smith PB, Young LW, Maxwell JR; Eunice Kennedy Shriver NICHD Neonatal Research Network and the NIH ECHO Program IDeA States Pediatrics Clinical Trials Network. Antenatal Exposure to Medication for Opioid Use Disorder and Infant Outcomes in the Eat, Sleep, Console for Neonatal Opioid Withdrawal Randomized Controlled Trial. J Pediatr. 2025 Oct 17;289:114859. doi: 10.1016/j.jpeds.2025.114859. Online ahead of print.

  PMID: 41110632 DERIVED

• Merhar SL, Hu Z, Devlin LA, Ounpraseuth ST, Simon AE, Smith PB, Walsh MC, Lee JY, Das A, Higgins RD, Crawford MM, Rice W, Paul DA, Maxwell JR, Telang SD, Fung CM, Wright T, Reynolds AM, Hahn D, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Tri; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Trials Network. Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2024 Oct 1;178(10):976-984. doi: 10.1001/jamapediatrics.2024.2578.

  PMID: 39133505 DERIVED

• Devlin LA, Hu Z, Merhar SL, Ounpraseuth ST, Simon AE, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Fung CM, Wright T, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Newman S, Snowden JN, Young LW; 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. 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. JAMA Pediatr. 2024 Jun 1;178(6):525-532. doi: 10.1001/jamapediatrics.2024.0544.

  PMID: 38619854 DERIVED

• 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. Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal. N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.

  PMID: 37125831 DERIVED

MeSH Terms

Interventions

Eating; Sleep

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Songthip Ounpraseuth
• Organization: University of Arkansas for Medical Sciences

stounpraseuth@uams.edu

5016867233

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The protocol study team will assure blinding of the electronically performed follow-up questionnaires through the use of a centralized computer scoring system. However, it will not be possible to blind responses to questionnaires that are performed with the assistance of research personnel at the participating sites. The protocol study team will note the method of questionnaire completion and will evaluate for bias in this context.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Stepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC tool

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 15, 2019
• Study Start: September 8, 2020
• Primary Completion: May 11, 2022
• Study Completion: September 24, 2024
• Last Updated: February 14, 2025
• Results First Posted: October 4, 2023

Record last verified: 2025-01

Locations

US (26)