NCT04057820

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,305 (actual)
• Sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program · Network
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Opiate Withdrawal Syndrome

Interventions

Type	Name	Description
OTHER	Finnegan Neonatal Abstinence Scoring Tool	The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.
OTHER	Eat, Sleep, Console (ESC) care tool	The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-05-11
• Completion: 2024-09-24
• First posted: 2019-08-15
• Last updated: 2025-02-14
• Results posted: 2023-10-04

Locations

26 sites across 1 country: United States