At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,305 enrolled
Drug / intervention
Finnegan Neonatal Abstinence Scoring Tool +1 moreother
Likely dose
Not stated in record
Key inclusion· 3
- ✓Infant being managed for neonatal opioid withdrawal syndrome (NOWS) at an eligible site with assessments and non-pharmacologic and/or pharmacologic care
- ✓Gestational age ≥36 weeks
- ✓Maternal history of prenatal opioid use OR maternal toxicology screen positive for opioids during second/third trimester OR infant toxicology screen positive for opioids during initial hospital stay
Key exclusion· 7
- ✕Major birth defect(s)
- ✕Neonatal encephalopathy (including hypoxic ischemic encephalopathy), metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life
- ✕Respiratory support (positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life
- ✕Antimicrobial therapy at 60 hours of life
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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·interventional·Posted Aug 15, 2019·Updated Feb 14, 2025
In Brief
A clinical study evaluating Finnegan Neonatal Abstinence Scoring Tool and Eat, Sleep, Console (ESC) care tool for Neonatal Opiate Withdrawal Syndrome. Completed, enrolled 1,305 participants across 26 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeonatal Opiate Withdrawal Syndrome
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedAug 2019
Enrollment StartSep 2020
Primary CompletionMay 2022
Study CompletionSep 2024
TodayJul 2026
First PostedAug 15, 2019
Enrollment StartSep 8, 2020
Primary CompletionMay 11, 2022
Study CompletionSep 24, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.9 years ago
Interventions
Finnegan Neonatal Abstinence Scoring Toolother
The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.
Eat, Sleep, Console (ESC) care toolother
The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.