Trial Outcomes & Findings for Neonatal Intensive Care Unit Virtual Family-Centered Rounds (NCT NCT05762835)

Family units enrolled and randomized. At time of enrollment, the number of infants was known, but the number of parents was unknown (because at that time did not know if family units had 1 vs. 2 parents/guardians). Enrolled 486 families (514 infants).

Unit of analysis: families

Each family consisted of different #s of infants (e.g., twins/other multiples) and different #s of parents (i.e., 1 to 2 parents/guardians per family) participants. At time of randomization, the number of infants was known, but the number of parents was unknown (because at that time did not know if family units had 1 vs. 2 parents/guardians).

Obtained from FCR weekday observations. Defined at family unit level, accounting for possibility of multiple enrolled infants per family and variable eligible FCR encounters for each infant. We will compute the total number of possible weekday FCR encounters per family ('denominator') and the number of those for which at least 1 parent is present virtually or in-person ('numerator'). The outcome measure will be reported as a proportion (numerator/denominator). For example, if a family has 2 infants, 1 whose NICU hospitalization included 5 eligible FCR encounters and another whose NICU hospitalization includes 7 eligible FCR encounters, that family will be counted as having twelve eligible FCR encounters ('denominator'). If at least 1 parent is present for 4 of the first infant's encounters and 6 of the second infant's encounters, the family would be counted as having attended 10 ('numerator') of the 12 eligible FCR encounters. The proportion for that family unit is 0.83.

Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).

Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)

Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)

Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)

Unit of measure: days in NICU. Obtained from electronic health record.

Dichotomous outcomes. Include (a) breastmilk feeding initiation, (b) any breastmilk feeding at the time of discharge from the NICU (and 90 days later), and (c) exclusive breastmilk feeding at the time of discharge from the NICU (and 90 days later). Breastmilk feeding includes consuming milk from the birth parent via any delivery method (e.g., bottle, feeding tube, breast). Any breastmilk feeding will be defined as the infant consuming any amount of milk from the birth parent, with or without the addition of formula or fortifier. Exclusive breastmilk feeding will be defined as 100% of base feeding type as milk from the birth parent, with or without a bovine or human fortifier. Obtained from electronic health record (0 days) and parent survey (90 days).

Measure/Tool: Sex-specific Fenton growth charts. This dichotomous outcome will define growth failure as a weight-for-gestational-age Z-score decline of more than 0.8 standard deviations (SD) from birth to discharge. Obtained from electronic health record.

Measure/Tool: Sex-specific Fenton growth charts. This categorical outcome will classify the degree of growth failure as none (no decline or a decline \</=0.8 SD), mild (\>0.8 and \</=1.2 SD), moderate (\>1.2 and \</=2 SD), or severe (\>2 SD). Obtained from electronic health record.

Continuous variable. Measure/Tool: Sex-specific Fenton growth charts. Calculate change in Z-score divided by number of days in the NICU. Obtained from electronic health record.

Include the rates of harmful errors, non-harmful errors, and overall errors (harmful errors plus non-harmful errors). Obtained via review of data from electronic health record, incident report system, and solicited reports. Two neonatologists, blinded to the study arm, will independently categorize each event as a harmful error (preventable adverse event), non-harmful error, non-preventable adverse event, or exclusion.

Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.

Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.

Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record.

Dichotomous variable defined as any occurrence during the NICU hospitalization of a laboratory-confirmed bacterial or viral bloodstream infection that develops with a central line in place and is not related to an infection at another site. Obtained from electronic health record.

Number of days among the total number of NICU days that the infant has an umbilical catheter or one or more central lines in place. Obtained from electronic health record.

Number of days among the total number of NICU days that the infant receives intramuscular or intravascular antibacterial or antifungal agents. Obtained from electronic health record.