Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
Overview
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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care)
- The infant is ≥ 36 weeks gestation
- 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
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Infant has major birth defect(s)
- Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life
- Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life
- Infant was receiving antimicrobial(s) at 60 hours of life
- Infant has received any major surgical intervention in the first 60 hours of life
- Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life
- Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Observational
Sponsor(s)
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program