Skip to main content

Table 2 Variation in definition of outcomes reported

From: Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review

Outcome

Reported outcome definition

Duration of pharmacotherapy (n = 32)

Days of opioid treatment

Duration of treatment for NAS symptoms

Duration of pharmacotherapy for NAS/NOWS

Days of treatment

Duration of treatment required for NAS resolution

Number of days on morphine

Duration of opioid treatment

Duration of oral morphine treatment

Length of opioid treatment

Length of methadone therapy

Duration of phenobarbital treatment

Total phenobarbital treatment days

Total treatment duration (hospital + home)

Length of treatment

Days on DTO

Days on any form of pharmacologic support

Duration of hospital stay (n = 31)

Days of inpatient hospitalization

Neonatal length of stay

Length of inpatient stay

Duration of hospital stay

Mean infant hospital stay

Average length of stay between hospitals

NICU level of care (n = 8)

NICU admission

Length of NICU stay

Admission to level II nursery or chronic care unit

Adverse event—unplanned ICU transfer

Transferred to NICU from inpatient unit

Breastfeeding or human milk nutrition (n = 12)

Breastfeeding during hospital stay

Breastfeeding at discharge

Initiation of breastfeeding

Breastfeeding rates 6–8 weeks of age

Rate of breastfeeding

Duration of breast feeding

Breastfeeding

Taking ≥50% of feed as breast milk at discharge

Discharge on human milk

Opioid withdrawal symptoms (n = 24)

Neonatal substance withdrawal

Withdrawal symptoms

Time of onset of symptoms

Severity of NAS/NOWS

Average daily score

Mean NAS score

Intensity of withdrawal

Control of withdrawal symptoms

Number of times NAS score >8

Mean Finnegan withdrawal scores

Treatment effectiveness

Duration of neonatal abstinence syndrome

Severity of NAS (mean peak NAS)

NAS scores (undefined time point)

Highest Finnegan score

Time to highest Finnegan score

Highest NAS score

Prevalence of symptoms of NAS

Custody at discharge (n = 7)

Custody status at discharge

Discharge of babies in the custody of their mothers

Child placed in foster care

Discharge in parental care

Discharge from hospital with their biological family

Dose of pharmacotherapy (n = 18)

Total dose (mg/kg) of methadone administered

Range of morphine doses (mg/kg/day)

Morphine doses during the first 38 days of treatment

Maximum morphine dose (mean mg/kg/day)

Initial median opioid dose (methadone or morphine PO)

Cumulative morphine dose

Total opioid dose

Maximum clonidine dose

Highest mean methadone dose given

Amount of DTO required to treat NAS

Mean total morphine dose

Maximum amount of morphine (mL/kg)

Time to maximum amount of oral morphine

Median dosages over time

Average phenobarbital dose

Addition of adjunctive therapy (n = 17)

Phenobarbital adjunct therapy

Percentage treated with an adjuvant medication

Adjunct medications

Addition of a second agent (clonidine or phenobarbital)

Amount of pharmacologic support

Addition of a second agent

Initiation of pharmacotherapy (n = 11)

Treated with morphine

Pharmacologic treatment for NAS

Need for treatment of NAS

Need for pharmacotherapy with morphine

Percentage of cohort requiring oral morphine

Weight (n = 7)

Weight gain

Discharge weight

Weight loss greater than 10% in the first week of life

Time to regain birthweight

Poor weight gain

Time to symptom control (n = 3)

Duration of treatment to achieve Lipsitz score below 4

Treatment response

Time to symptom control after initiation of therapy

Cost of treatment (n = 6)

Costs for all opioid-exposed infants

Costs for all opioid-exposed infants treated pharmacologically

Average hospital cost per infant

Total cost of treatment

Average total cost of hospitalization (direct and indirect)

Cost-effectiveness

Development (n = 2)

Infant neurobehavior

Neurobehavior

Adverse events (n = 14)

Safety of noninsertive acupuncture

Neonatal safety (adverse drug reactions)

Safe

Safety (adverse events)

Seizures

Mortality in hospital

Infant death

Unintended side effects

Readmission to hospital (n = 9)

Return to hospital for withdrawal treatment

Readmission to hospital

Readmission in 1 week postdischarge

Readmission in the first year of life

Hospital readmission 2 months following discharge

30-day readmissions (all cause)

30-day readmission (withdrawal)

  1. n represents the number of times an outcome category was reported as either a primary or secondary outcome; difference between number of times an outcome category was reported and the number of articles reporting an outcome category is secondary to the use of composite outcomes
  2. DTO diluted tincture of opium, ICU intensive care unit, NAS neonatal abstinence syndrome, NICU neonatal intensive care unit, NOWS neonatal opioid withdrawal syndrome, PO per oral, mLmililiters, kg kilograms