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

Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program

Status: Completed

Conditions: Neonatal Opiate Withdrawal Syndrome

Treatments: Other: Finnegan Neonatal Abstinence Scoring Tool; Other: Eat, Sleep, Console (ESC) care tool

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT04057820

3U2COD023375-06S1 (U.S. NIH Grant/Contract)

ACTNOW-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,305 patients

Sex: All

Ages: Under 3 days old

Volunteers: No 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:

  2. Maternal history of prenatal opioid use

  3. Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy

  4. 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,305 participants in 2 patient groups

Usual care, Finnegan Neonatal Abstinence Scoring Tool

Active Comparator group

Description:

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

Treatment:

Other: Finnegan Neonatal Abstinence Scoring Tool

Eat, Sleep, Console care tool

Active Comparator group

Description:

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

Treatment:

Other: Eat, Sleep, Console (ESC) care tool