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

Time from birth until medically ready for discharge (Finnegan Cohort only)

Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria: * 96 hours of age * 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine) This secondary outcome is for infants assessed and managed using Finnegan.

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

Receipt of pharmacologic treatment (ESC Cohort)

If the infant received opioid replacement therapy prior to hospital discharge and was managed using ESC.

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

Length of hospital stay (ESC Cohort)

Number of days infant remained in the hospital and managed with ESC.

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

Total number opioid doses (ESC Cohort)

The total number of opioid doses administered among infants managed with ESC and pharmacologically treated during initial hospitalization.

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

Receipt of secondary medications (ESC Cohort)

The total number of secondary opioid doses administered among infants managed with ESC and pharmacologically treated during initial 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 (ESC Cohort)

The total number of infants managed with ESC and pharmacologically treated during initial 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 (ESC Cohort)

The total number of infants managed with ESC and pharmacologically treated during initial 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.

Receipt of pharmacologic treatment (Finnegan Cohort)

If the infant received opioid replacement therapy prior to hospital discharge and was managed using Finnegan.

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

Length of hospital stay (Finnegan Cohort)

Number of days infant remained in the hospital and managed with Finnegan.

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

Total number opioid doses (Finnegan Cohort)

The total number of opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial hospitalization.

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

Receipt of secondary medications (Finnegan Cohort)

The total number of secondary opioid doses administered among infants managed with Finnegan and pharmacologically treated during initial 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 (Finnegan Cohort)

The total number of infants managed with Finnegan and pharmacologically treated during initial 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 (Finnegan Cohort)

The total number of infants managed with Finnegan and pharmacologically treated during initial 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.

Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent)

A composite safety outcome for infants at risk for pharmacologic treatment, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss \>15% from birthweight

Time frame: From date of birth until hospital discharge

Inpatient Composite Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent)

A composite safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Seizures, Excessive weight loss \>15% from birthweight

Time frame: From birth until hospital discharge

Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with ESC (present/absent)

A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death

Time frame: From birth until hospital discharge

Inpatient Composite Critical Safety Outcome for infants at risk for pharmacologic treatment, managed with Finnegan (present/absent)

From birth until hospital discharge

Time frame: A composite critical safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma, Death

Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent)

A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions

Time frame: From hospital discharge to 3 months of age

Outpatient Composite Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent)

A composite outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits, Hospital readmissions

Time frame: From hospital discharge to 3 months of age

Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with ESC (present/absent)

A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with ESC defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death

Time frame: From hospital discharge to 3 months of age

Outpatient Composite Critical Safety Outcome at risk for pharmacologic treatment, managed with Finnegan (present/absent)

A composite critical outpatient safety outcome for infants at risk for pharmacologic treatment, managed with Finnegan defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma, Death

Time frame: From hospital discharge to 3 months of age

Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

A composite safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss \>15% from birthweight

Time frame: From birth to hospital discharge

Inpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)

A composite safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Seizures; Excessive weight loss \>15% from birthweight.

Time frame: From birth to hospital discharge

Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

A composite critical safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death.

Time frame: From birth to hospital discharge

Inpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)

A composite critical safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between birth and hospital discharge: Non accidental trauma; Death.

Time frame: From birth to hospital discharge

Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

A composite outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions.

Time frame: From hospital discharge to 3 months of age

Outpatient Composite Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent

A composite outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Acute/urgent care or emergency room visits; Hospital readmissions.

Time frame: From hospital discharge to 3 months of age

Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with ESC (present/absent)

A composite critical outpatient safety outcome for infants treated pharmacologically, managed with ESC, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death.

Time frame: From hospital discharge to 3 months of age

Outpatient Composite Critical Safety Outcome for infants treated pharmacologically, managed with Finnegan (present/absent)

A composite critical outpatient safety outcome for infants treated pharmacologically, managed with Finnegan, defined as the occurrence of any of the following events between hospital discharge and 3 months of age: Non accidental trauma; Death.

Time frame: From hospital discharge to 3 months of age