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

Primary Purpose

Neonatal Opiate Withdrawal Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Finnegan Neonatal Abstinence Scoring Tool
Eat, Sleep, Console (ESC) care tool
Sponsored by
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neonatal Opiate Withdrawal Syndrome focused on measuring NOWS

Eligibility Criteria

undefined - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chistiana Care Health Systems
  • Tampa General Hospital
  • Kapiolani Hospital
  • Kansas University Medical Center
  • Shawnee Mission Medical Center
  • St. Elizabeth Healthcare/CCHMC
  • Norton Children's Hospital
  • Tulane University School of Medicine
  • Winchester Hospital
  • University of Mississippi Medical Center
  • University of Nebraska Medical Center
  • University of New Mexico
  • University of Buffalo
  • University of Rochester
  • Duke Hospital
  • Good Samaritan Hospital
  • University of Cincinnati
  • Case Western Reserve University
  • Nationwide Children's Hospital
  • Oklahoma University Health Sciences Center
  • Hospital of the University of Pennsylvania
  • Pennsylvania Hospital
  • Medical University of South Carolina
  • Spartanburg Regional Medical Center
  • Sanford Health
  • University of Utah Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual care, Finnegan Neonatal Abstinence Scoring Tool

Eat, Sleep, Console care tool

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Did Infant Receive Opioid Replacement Therapy (Yes/no)
Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge
Total Dose of Opioid Replacement Therapy Infant Received
If infant received opioid replacement therapy, the units received (mg/kg).
Time Until Initiation of Opioid Replacement
If infant received opioid replacement therapy, the timing of the initiation of therapy
Receipt of Adjuvant Therapy
To see if the infant had to have any other type of therapy for NOWS (yes/no)
Maximum Percent Change in Weight During Initial Birth Hospitalization
Assess percent change in birthweight during hospitalization (i.e., [minimum weight - birth weight] / birth weight)
Feeding Type at Discharge (Exclusive Maternal Breast Milk)
Exclusive maternal breast milk feeding at the time of hospital discharge
Any Direct Breast Feeding at Discharge
Direct breastfeeding within 24 hours of hospital discharge (yes/no)
Length of Hospital Stay
Time from birth until infants being managed for NOWS are discharged from the hospital
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
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)
Critical Safety Outcome
any non-accidental trauma and death (yes/no)

Full Information

First Posted
August 9, 2019
Last Updated
September 11, 2023
Sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04057820
Brief Title
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Acronym
(ESC-NOW)
Official Title
Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
May 11, 2022 (Actual)
Study Completion Date
November 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Opiate Withdrawal Syndrome
Keywords
NOWS

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
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.
Allocation
Randomized
Enrollment
1305 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care, Finnegan Neonatal Abstinence Scoring Tool
Arm Type
Active Comparator
Arm Description
Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)
Arm Title
Eat, Sleep, Console care tool
Arm Type
Active Comparator
Arm Description
New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool
Intervention Type
Other
Intervention Name(s)
Finnegan Neonatal Abstinence Scoring Tool
Other Intervention Name(s)
FNAST
Intervention Description
The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.
Intervention Type
Other
Intervention Name(s)
Eat, Sleep, Console (ESC) care tool
Other Intervention Name(s)
ESC
Intervention Description
The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Primary Outcome Measure Information:
Title
Time From Birth Until Medically Ready for Discharge
Description
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.
Time Frame
from date of birth until hospital discharge or 1 year whichever comes first
Secondary Outcome Measure Information:
Title
Did Infant Receive Opioid Replacement Therapy (Yes/no)
Description
Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge
Time Frame
From date of birth until hospital discharge or 1 year whichever comes first
Title
Total Dose of Opioid Replacement Therapy Infant Received
Description
If infant received opioid replacement therapy, the units received (mg/kg).
Time Frame
From date of birth until hospital discharge or 1 year whichever comes first
Title
Time Until Initiation of Opioid Replacement
Description
If infant received opioid replacement therapy, the timing of the initiation of therapy
Time Frame
From date of birth until hospital discharge or 1 year whichever comes first
Title
Receipt of Adjuvant Therapy
Description
To see if the infant had to have any other type of therapy for NOWS (yes/no)
Time Frame
from date of birth until hospital discharge or 1 year whichever comes first
Title
Maximum Percent Change in Weight During Initial Birth Hospitalization
Description
Assess percent change in birthweight during hospitalization (i.e., [minimum weight - birth weight] / birth weight)
Time Frame
from date of birth until hospital discharge or 1 year whichever comes first
Title
Feeding Type at Discharge (Exclusive Maternal Breast Milk)
Description
Exclusive maternal breast milk feeding at the time of hospital discharge
Time Frame
from date of birth until hospital discharge or 1 year whichever comes first
Title
Any Direct Breast Feeding at Discharge
Description
Direct breastfeeding within 24 hours of hospital discharge (yes/no)
Time Frame
within 24 hours of hospital discharge
Title
Length of Hospital Stay
Description
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
Title
Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)
Description
composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy
Time Frame
from date of birth until hospital discharge or 1 year whichever comes first
Title
Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions
Description
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
Title
Critical Safety Outcome
Description
any non-accidental trauma and death (yes/no)
Time Frame
at 3 months of age.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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: Maternal history of prenatal opioid use Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy 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
Facility Information:
Facility Name
Chistiana Care Health Systems
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Kapiolani Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Shawnee Mission Medical Center
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
St. Elizabeth Healthcare/CCHMC
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University School of Medicine
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Winchester Hospital
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-1205
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Oklahoma University Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
University of Utah Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

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

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