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

NCT ID: NCT04057820

Last Updated: 2025-02-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2024-09-24

Brief Summary

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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.

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Detailed Description

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This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care to the ESC care approach).

During the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.

The site research team will obtain informed consent from the legal guardian(s) to obtain long-term outcomes for eligible infants and caregivers. Clinical site research team members may obtain this consent at any point during the hospital stay for infants who meet the trial's inclusion criteria. This data will allow the protocol study team to short- and long-term outcomes for infants managed with the ESC care approach compared to usual institutional care.

Conditions

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Neonatal Opiate Withdrawal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Usual care, Finnegan Neonatal Abstinence Scoring Tool

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

Group Type ACTIVE_COMPARATOR

Finnegan Neonatal Abstinence Scoring Tool

Intervention Type OTHER

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

Eat, Sleep, Console care tool

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

Group Type ACTIVE_COMPARATOR

Eat, Sleep, Console (ESC) care tool

Intervention Type OTHER

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

Interventions

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Finnegan Neonatal Abstinence Scoring Tool

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

Intervention Type OTHER

Eat, Sleep, Console (ESC) care tool

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

Intervention Type OTHER

Other Intervention Names

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FNAST ESC

Eligibility Criteria

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Inclusion Criteria

* 1\. 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:

1. Maternal history of prenatal opioid use
2. Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
3. Infant toxicology screen positive for opioids during the initial hospital stay

Exclusion Criteria

* 1\. 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
Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chistiana Care Health Systems

Newark, Delaware, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Kapiolani Hospital

Honolulu, Hawaii, United States

Site Status

Kansas University Medical Center

Kansas City, Kansas, United States

Site Status

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Site Status

St. Elizabeth Healthcare/CCHMC

Edgewood, Kentucky, United States

Site Status

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status

Tulane University School of Medicine

Metairie, Louisiana, United States

Site Status

Winchester Hospital

Winchester, Massachusetts, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

University of Buffalo

Buffalo, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Duke Hospital

Durham, North Carolina, United States

Site Status

Good Samaritan Hospital

Cincinnati, Ohio, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Oklahoma University Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Sanford Health

Sioux Falls, South Dakota, United States

Site Status

University of Utah Medical Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39133505 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38619854 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37125831 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: General Consent

View Document

Document Type: Informed Consent Form: Consent for parent and minor mother

View Document

Document Type: Informed Consent Form: Consent for caregiver only

View Document

Document Type: Informed Consent Form: Consent for baby only

View Document

Other Identifiers

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3U2COD023375-06S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ACTNOW-01

Identifier Type: -

Identifier Source: org_study_id

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