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

Study Overview
=================
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.

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

Conditions
-----------------
Neonatal Opiate Withdrawal Syndrome

Intervention / Treatment
-----------------
* Other: Finnegan Neonatal Abstinence Scoring Tool
* Other: Eat, Sleep, Console (ESC) care tool


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 3 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care, Finnegan Neonatal Abstinence Scoring Tool<br>Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) | Other: Finnegan Neonatal Abstinence Scoring Tool<br>* The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.<br>* Other names: FNAST;|
| Active Comparator: Eat, Sleep, Console care tool<br>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<br>* The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.<br>* 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NOWS