Table 3.

Descriptive Summary of Safety Measures.^*

Variable	Usual Care (N =702)	Eat, Sleep, Console Care Approach (N = 603)
	number of patients (percent)
Inpatient outcome
Composite safety outcome†	1 (<1)	2 (<1)
Seizures	1 (<1)	0
Accidental trauma	0	2 (<1)
Outcome at 3 mo
Composite safety outcome‡	113 (16)	86 (14)
Acute or urgent care visit	40 (6)	13 (2)
Emergency department visit	66 (9)	47 (8)
Hospitalization§	24 (3)	35 (6)
Composite critical safety outcome	5(1)	1 (<1)
Nonaccidental trauma	4(1)	1 (<1)
Death	2 (< 1)	0

^*Individual components of the composite outcomes are not mutually exclusive.

^†During the inpatient period, the composite safety outcome was the occurrence of seizures, accidental trauma (e.g., a fall off of a surface), or respiratory insufficiency (apnea or need for positive-pressure ventilation or supplemental oxygen); no patients had respiratory insufficiency during the inpatient period. In addition, no patients had a critical safety outcome, which was defined as nonaccidental trauma (an intentional injury as recorded in the medical record because of a pattern of injury or following formal evaluation) or death during the inpatient period.

^‡The composite safety outcome at 3 months was the only outcome that had sufficient data to perform any statistical modeling or inferential analysis.

^§Among the hospitalizations, the proportion of infants who were hospitalized for potential diagnoses related to neonatal opioid withdrawal syndrome was 1.9% (13 of 702 infants) in the usual-care group and 2.5% (15 of 603 infants) in the Eat, Sleep, Console group. Classification of diagnoses as potentially related to opioid withdrawal was determined according to the International Classification of Diseases, 10th revision, code review and included codes for failure to thrive, fussy baby, diaper dermatitis, neonatal withdrawal, fever, feeding problems, abnormal weight loss, tachypnea, vomiting, nystagmus, newborn exposure, and severe malnutrition.