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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neonatal Opiate Withdrawal Syndrome
• Intervention / Treatment: Other: Finnegan Neonatal Abstinence Scoring Tool; Other: Eat, Sleep, Console (ESC) care tool

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
• Enrollment (Actual): 1305
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Chistiana Care Health Systems
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
    • Shawnee Mission, Kansas, United States, 66204
      • Shawnee Mission Medical Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare/CCHMC
    • Louisville, Kentucky, United States, 40202
      • Norton Children's Hospital
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Tulane University School of Medicine
  • Massachusetts
    • Winchester, Massachusetts, United States, 01890
      • Winchester Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198-1205
      • University of Nebraska Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43215
      • Nationwide Children's Hospital
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University Health Sciences Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Medical Center
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Health
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Did Infant Receive Opioid Replacement Therapy (Yes/no)	Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge	From date of birth until hospital discharge or 1 year whichever comes first
Total Dose of Opioid Replacement Therapy Infant Received	If infant received opioid replacement therapy, the units received (mg/kg).	From date of birth until hospital discharge or 1 year whichever comes first
Time Until Initiation of Opioid Replacement	If infant received opioid replacement therapy, the timing of the initiation of therapy	From date of birth until hospital discharge or 1 year whichever comes first
Receipt of Adjuvant Therapy	To see if the infant had to have any other type of therapy for NOWS (yes/no)	from date of birth until hospital discharge or 1 year whichever comes first
Maximum Percent Change in Weight During Initial Birth Hospitalization	Assess percent change in birthweight during hospitalization (i.e., [minimum weight - birth weight] / birth weight)	from date of birth until hospital discharge or 1 year whichever comes first
Feeding Type at Discharge (Exclusive Maternal Breast Milk)	Exclusive maternal breast milk feeding at the time of hospital discharge	from date of birth until hospital discharge or 1 year whichever comes first
Any Direct Breast Feeding at Discharge	Direct breastfeeding within 24 hours of hospital discharge (yes/no)	within 24 hours of hospital discharge
Length of Hospital Stay	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
Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)	composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy	from date of birth until hospital discharge or 1 year whichever comes first
Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions	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
Critical Safety Outcome	any non-accidental trauma and death (yes/no)	at 3 months of age.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Actual): May 11, 2022
• Study Completion (Estimated): November 11, 2024

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: NOWS
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Substance Withdrawal Syndrome
• Other Study ID Numbers: ACTNOW-01; 3U2COD023375-06S1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No