Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach (OPTimize NOW)
Neonatal Opiate Withdrawal Syndrome
About this trial
This is an interventional treatment trial for Neonatal Opiate Withdrawal Syndrome focused on measuring NOWS
Eligibility Criteria
Inclusion Criteria: The infant is greater than or equal to 36 weeks gestation. The infant had antenatal opioid exposure identified by at least one of the following: History of maternal opioid use during pregnancy; Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or Positive infant toxicology screen for opioids during the initial hospital stay. The infant is being assessed and managed for NOWS at an eligible study site. The infant is at risk for pharmacologic treatment for NOWS defined by either of the following At least 1 score ≥ 8 if assessed and managed with FNAST or modification thereof At least 1 "yes" if assessed and managed with the ESC care approach Exclusion Criteria: The infant has major birth defect(s). The infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment. The infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age. The infant has undergone major surgical intervention prior to or at 48 hours of age. The infant has postnatal opioid exposure prior to the initiation of treatment for NOWS. The infant was outborn and pharmacologic treatment was initiated at the transferring hospital. The infant is assessed for eligibility during the study site's two-week washout period.
Sites / Locations
- University of Alabama at Birmingham
- University of Arkansas for Medical Sciences
- Sidney & Lois Eskenazi Hospital
- University of Louisville Hospital
- St. Elizabeth Healthcare
- Norton Children's Hospital
- University of New Mexico Health Sciences Center
- Good Samaritan Hospital
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Other
Other
Sequence 1
Sequence 2
This sequence will assign eligible participants to scheduled opioid taper approach for 5 months followed by a 2-week washout period followed by symptom-based dosing approach for 5 months.
This sequence will assign eligible participants to symptom-based dosing approach for 5 months followed by a 2-week washout period followed by scheduled opioid taper approach for 5 months.