Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach

Receipt of pharmacologic treatment

If the infant received opioid replacement therapy prior to hospital discharge.

Time frame: From date of birth until hospital discharge or 1 year, whichever comes first.

Length of hospital stay

Number of days infant remained in the hospital

Time frame: From date of birth until hospital discharge or 1 year, whichever comes first.

Safety outcomes

Safety outcomes including presence or absence of inpatient seizures, excessive weight loss of more than 15% from birthweight, and non-accidental trauma and death, and outpatient acute/urgent care or emergency room visits, hospital readmissions, and non-accidental trauma and death

Time frame: From date of birth until 3 months of life

Total number opioid doses

The total number of opioid doses administered among all infants pharmacologically treated during initial hospitalization.

Time frame: From date of birth until hospital discharge or 1 year, whichever comes first.

Receipt of secondary medications

The total number of secondary opioid doses administered among all infants pharmacologically treated during intital hospitalization.

Time frame: From date of birth until hospital discharge or 1 year, whichever comes first.

Transition from treatment with a symptom-based dosing approach to a scheduled opioid taper approach

The total number of infants pharmacologically treated during intital hospitalization who transitioned from a symptom-based dosing approach to a scheduled opioid taper approach

Time frame: From date of birth until hospital discharge or 1 year, whichever comes first.

Stopped scheduled opioid taper treatment

The total number of infants pharmacologically treated during intital hospitalization who were initially treated with a scheduled opioid taper but stopped treatment due to excessive sedation or respiratory depression

Time frame: From date of birth until hospital discharge or 1 year, whichever comes first.

Safety outcomes

Safety outcomes among infants pharmacologically treated during initial hospitalization including presence or absence of inpatient seizures, excessive weight loss of more than 15% from birthweight, and non-accidental trauma and death, and outpatient acute/urgent care or emergency room visits, hospital readmissions, and non-accidental trauma and death

Time frame: From date of birth until hospital discharge or 1 year, whichever comes first.