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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

Must not have

Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital

Infant was receiving antimicrobial(s) at 60 hours of life

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of birth until hospital discharge or 1 year whichever comes first

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My infant is receiving care for withdrawal symptoms at a qualified facility.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My baby was transferred to another hospital after 60 hours of birth or received opioid treatment for withdrawal.

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My infant was on antibiotics within 60 hours of being born.

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My infant was diagnosed with a brain condition like encephalopathy or stroke within 60 hours of birth.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of birth until hospital discharge or 1 year whichever comes first for reporting.