Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symp… (NCT05980260) | Clinical Trial Compass
CompletedPhase 3
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
United States626 participantsStarted 2024-03-25
Plain-language summary
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today:
1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper.
2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given.
We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.
Who can participate
Age range1 Hour – 48 Hours
SexALL
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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:
✓. 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
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.
What they're measuring
1
Time from birth until medically ready for discharge
Timeframe: From date of birth until hospital discharge or 1 year, whichever comes first.