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

Completed · Not applicable

Conditions studied: Neonatal Opiate Withdrawal Syndrome

In brief

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.

Key facts

Study ID

NCT04057820

Run by

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

People needed

1305

Starts

2020-09-08

Expected to finish

2024-09-24

Last updated by the study team

2025-02-14

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:
• Maternal history of prenatal opioid use
• Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
• Infant toxicology screen positive for opioids during the initial hospital stay

You may not qualify if…

• 1. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital

Where it is running

• Chistiana Care Health Systems — Newark, Delaware, United States
• Tampa General Hospital — Tampa, Florida, United States
• Kapiolani Hospital — Honolulu, Hawaii, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Shawnee Mission Medical Center — Shawnee Mission, Kansas, United States
• St. Elizabeth Healthcare/CCHMC — Edgewood, Kentucky, United States
• Norton Children's Hospital — Louisville, Kentucky, United States
• Tulane University School of Medicine — Metairie, Louisiana, United States
• Winchester Hospital — Winchester, Massachusetts, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of Buffalo — Buffalo, New York, United States
• University of Rochester — Rochester, New York, United States
• Duke Hospital — Durham, North Carolina, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Oklahoma University Health Sciences Center — Oklahoma City, Oklahoma, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• Sanford Health — Sioux Falls, South Dakota, United States

Full record on ClinicalTrials.gov

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