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

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program1,305 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

1,305

Conditions

Neonatal Opiate Withdrawal Syndrome

Interventions

Finnegan Neonatal Abstinence Scoring ToolOTHER

The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.

Eat, Sleep, Console (ESC) care toolOTHER

The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.

Eligibility

Sex: ALLMax age: 3 Days

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

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.

Time frame: from date of birth until hospital discharge or 1 year whichever comes first

Secondary Outcomes

Did Infant Receive Opioid Replacement Therapy (Yes/no)

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

Total Dose of Opioid Replacement Therapy Infant Received

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

Time Until Initiation of Opioid Replacement

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

Receipt of Adjuvant Therapy

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

Maximum Percent Change in Weight During Initial Birth Hospitalization

Assess percent change in birthweight during hospitalization (i.e., \[minimum weight - birth weight\] / birth weight)

Data from ClinicalTrials.gov

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