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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04057820
Recruitment Status : Active, not recruiting
First Posted : August 15, 2019
Last Update Posted : April 18, 2023
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

Study Description
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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
Neonatal Opiate Withdrawal Syndrome Other: Finnegan Neonatal Abstinence Scoring Tool Other: Eat, Sleep, Console (ESC) care tool Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : September 8, 2020
Actual Primary Completion Date : May 11, 2022
Estimated Study Completion Date : November 11, 2024
Arms and Interventions
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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 Name: 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 Name: ESC


Outcome Measures
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Primary Outcome Measures :
  1. Time from birth until medically ready for discharge [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: at 3 months of age. ]
    any non-accidental trauma and death


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057820


Locations
Show Show 26 study locations
Sponsors and Collaborators
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
National Institutes of Health (NIH)
  Study Documents (Full-Text)

Documents provided by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program:
Study Protocol and Statistical Analysis Plan  [PDF] March 28, 2022
Informed Consent Form: General Consent  [PDF] March 9, 2020
Informed Consent Form: Consent for parent and minor mother  [PDF] March 9, 2020
Informed Consent Form: Consent for caregiver only  [PDF] February 18, 2021
Informed Consent Form: Consent for baby only  [PDF] January 11, 2021

More Information
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Responsible Party: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
ClinicalTrials.gov Identifier: NCT04057820    
Other Study ID Numbers: ACTNOW-01
3U2COD023375-06S1 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: April 18, 2023
Last Verified: April 2023

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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:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders