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

NCT04057820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1305

Last updated 2025-02-14

Study results available
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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.

Conditions

  • Neonatal Opiate Withdrawal Syndrome

Interventions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

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

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2022-05-11
Completion
2024-09-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057820 on ClinicalTrials.gov