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

Neonatal Opiate Withdrawal Syndrome Clinical Trial

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

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Neonatal Opiate Withdrawal Syndrome
• Substance Withdrawal Syndrome

• NCT number: NCT04057820
• Study type: Interventional
• Source: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2020
• Completion date: November 11, 2024