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

• ClinicalTrials.gov Identifier: NCT04057820
• Recruitment Status: Active, not recruiting
• First Posted: August 15, 2019
• Last Update Posted: April 18, 2023
• Sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
• Collaborator: National Institutes of Health (NIH)
• Information provided by (Responsible Party): Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

Tracking Information

• First Submitted Date: August 9, 2019
• First Posted Date: August 15, 2019
• Last Update Posted Date: April 18, 2023
• Actual Study Start Date: September 8, 2020
• Actual Primary Completion Date: May 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 13, 2019)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 13, 2019)

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• Critical safety outcome (present/absent) [ Time Frame: at 3 months of age. ]
  any non-accidental trauma and death

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Neonatal Opiate Withdrawal Syndrome

Intervention

• 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
• 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

Study Arms

• Active Comparator: Usual care, Finnegan Neonatal Abstinence Scoring Tool
  Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)
  Intervention: Other: Finnegan Neonatal Abstinence Scoring Tool
• 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
  Intervention: Other: Eat, Sleep, Console (ESC) care tool

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 13, 2019): 864
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 11, 2024
• Actual Primary Completion Date: May 11, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 3 Days (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04057820
• Other Study ID Numbers: ACTNOW-01; 3U2COD023375-06S1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
• Original Responsible Party: IDeA States Pediatric Clinical Trials Network
• Current Study Sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
• Original Study Sponsor: IDeA States Pediatric Clinical Trials Network
• Collaborators: National Institutes of Health (NIH)
• Investigators: Not Provided
• PRS Account: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
• Verification Date: April 2023