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Eat, Sleep, Console Approach for Neonatal Abstinence Syndrome ((ESC-NOW) Trial)
N/A
Waitlist Available
Research Sponsored by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of birth until hospital discharge or 1 year whichever comes first
Awards & highlights
(ESC-NOW) Trial Summary
This trial is testing a new way to care for infants with neonatal abstinence syndrome (NAS) to see if it reduces the time until they are ready for discharge.
Who is the study for?
This trial is for infants ≥36 weeks gestation managed for Neonatal Opioid Withdrawal Syndrome (NOWS) due to maternal opioid use or positive opioid toxicology in mother/infant. Infants with severe neurological conditions, major surgeries, infections diagnosed by 60 hours of life, or those transferred after 60 hours are excluded.Check my eligibility
What is being tested?
The study tests if the Eat, Sleep, Console (ESC) care approach can shorten hospital stay until infants with NOWS are ready for discharge compared to the traditional Finnegan scoring method. The ESC focuses on functional outcomes like feeding and consoling abilities.See study design
What are the potential side effects?
Since this trial compares assessment tools rather than medications, there aren't direct side effects from interventions. However, different management approaches may affect infant comfort and withdrawal symptoms.
(ESC-NOW) Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My infant is receiving care for withdrawal symptoms at a qualified facility.
(ESC-NOW) Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of birth until hospital discharge or 1 year whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of birth until hospital discharge or 1 year whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time From Birth Until Medically Ready for Discharge
Secondary outcome measures
Any Direct Breast Feeding at Discharge
Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions
Critical Safety Outcome
+8 more(ESC-NOW) Trial Design
2Treatment groups
Active Control
Group I: Usual care, Finnegan Neonatal Abstinence Scoring ToolActive Control1 Intervention
Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)
Group II: Eat, Sleep, Console care toolActive Control1 Intervention
New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool
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Who is running the clinical trial?
Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) ProgramLead Sponsor
2 Previous Clinical Trials
490 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,492,922 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The baby has a serious physical defect since birth.My baby was transferred to another hospital after 60 hours of birth or received opioid treatment for withdrawal.My infant is receiving care for withdrawal symptoms at a qualified facility.The baby was given breathing assistance like oxygen therapy, not related to medicine treatment, within 60 hours of birth due to NOWS.My infant was on antibiotics within 60 hours of being born.My newborn was exposed to opioids only for NOWS treatment in the first 60 hours.My infant was diagnosed with a brain condition like encephalopathy or stroke within 60 hours of birth.My infant had major surgery within the first 60 hours of life.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care, Finnegan Neonatal Abstinence Scoring Tool
- Group 2: Eat, Sleep, Console care tool
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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