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

Sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04057820
Collaborator
National Institutes of Health (NIH) (NIH)
864
Enrollment
26
Locations
2
Arms
50.1
Anticipated Duration (Months)
33.2
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Finnegan Neonatal Abstinence Scoring Tool
  • Other: Eat, Sleep, Console (ESC) care tool
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
864 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Stepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC toolStepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC tool
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Health Services Research
Official Title:
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Actual Study Start Date :
Sep 8, 2020
Actual Primary Completion Date :
May 11, 2022
Anticipated Study Completion Date :
Nov 11, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Usual care, Finnegan Neonatal Abstinence Scoring Tool

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

Other: 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.
Other Names:
  • FNAST

    		•
    Active Comparator: Eat, Sleep, Console care tool

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time from birth until medically ready for discharge [from date of birth until hospital discharge or 1 year whichever comes first]

      The number of days from birth until the infant is determined to be medically ready for discharge per protocol

    Secondary Outcome Measures

    1. Did infant receive opioid replacement therapy (yes/no) [From date of birth until hospital discharge or 1 year whichever comes first]

      Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge

    2. Total dose of opioid replacement therapy infant received [From date of birth until hospital discharge or 1 year whichever comes first]

      If infant received opioid replacement therapy, the units received

    3. Hour of life opioid replacement initiated [From date of birth until hospital discharge or 1 year whichever comes first]

      If infant received opioid replacement therapy, the timing of the initiation of therapy

    4. Receipt of adjuvant therapy (yes/no) [from date of birth until hospital discharge or 1 year whichever comes first]

      To see if the infant had to have any other type of therapy for NOWS

    5. Maximum percent change in weight during initial birth hospitalization [from date of birth until hospital discharge or 1 year whichever comes first]

      Assess change in weight during hospitalization

    6. The Caregiver Questionnaire will assess the proportion of infants who receive maternal breastmilk at the time of hospital discharge [from date of birth until hospital discharge or 1 year whichever comes first]

      To determine if infant received breastmilk, formula, combination of each

    7. Direct breastfeeding within 24 hours of hospital discharge (yes/no) [within 24 hours of hospital discharge]

      Was infant breastfed within 24 hours of hospital discharge

    8. Time from birth until infants being managed for NOWS are discharged from the hospital [from date of birth until hospital discharge or 1 year whichever comes first]

      To determine the overall time all infants in study are discharged from the hospital

    9. Inpatient composite safety outcome which includes seizures, accidental trauma, respiratory insufficiency due to opioid therapy (present/absent) [from date of birth until hospital discharge or 1 year whichever comes first]

      composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy

    10. Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent) [at 3 months of age]

      composite of the following: acute/urgent care and/or emergency room visits, hospital readmissions

    11. Critical safety outcome (present/absent) [at 3 months of age.]

      any non-accidental trauma and death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 3 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    1. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:

    2. Maternal history of prenatal opioid use

    3. Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy

    4. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chistiana Care Health Systems Newark Delaware United States 19718
    2 Tampa General Hospital Tampa Florida United States 33606
    3 Kapiolani Hospital Honolulu Hawaii United States 96826
    4 Kansas University Medical Center Kansas City Kansas United States 66160
    5 Shawnee Mission Medical Center Shawnee Mission Kansas United States 66204
    6 St. Elizabeth Healthcare/CCHMC Edgewood Kentucky United States 41017
    7 Norton Children's Hospital Louisville Kentucky United States 40202
    8 Tulane University School of Medicine Metairie Louisiana United States 70001
    9 Winchester Hospital Winchester Massachusetts United States 01890
    10 University of Mississippi Medical Center Jackson Mississippi United States 39216
    11 University of Nebraska Medical Center Omaha Nebraska United States 68198-1205
    12 University of New Mexico Albuquerque New Mexico United States 87106
    13 University of Buffalo Buffalo New York United States 14203
    14 University of Rochester Rochester New York United States 14642
    15 Duke Hospital Durham North Carolina United States 27710
    16 Good Samaritan Hospital Cincinnati Ohio United States 45220
    17 University of Cincinnati Cincinnati Ohio United States 45229
    18 Case Western Reserve University Cleveland Ohio United States 44106
    19 Nationwide Children's Hospital Columbus Ohio United States 43215
    20 Oklahoma University Health Sciences Center Oklahoma City Oklahoma United States 73104
    21 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    22 Pennsylvania Hospital Philadelphia Pennsylvania United States 19107
    23 Medical University of South Carolina Charleston South Carolina United States 29425
    24 Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
    25 Sanford Health Sioux Falls South Dakota United States 57105
    26 University of Utah Medical Center Salt Lake City Utah United States 84108

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
    ClinicalTrials.gov Identifier:
    NCT04057820
    Other Study ID Numbers:
    • ACTNOW-01
    • 3U2COD023375-06S1
    First Posted:
    Aug 15, 2019
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
    NOWS
    Additional relevant MeSH terms:
    Substance Withdrawal Syndrome

    Study Results

    No Results Posted as of Jul 8, 2022