Neonatal Intensive Care Unit Virtual Family-Centered Rounds

Not Applicable

Completed

• Conditions: Pediatric Disorder; Neonatal Disease
• Interventions: Behavioral: Virtual family-centered rounds (FCR)

• Registration Number: NCT05762835
• Lead Sponsor: University of California, Davis

Brief Summary

The aim of this study is to evaluate the impact of virtual family-centered rounds in the neonatal intensive care unit on parental and neonatal outcomes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-10
• Study Start: 2023-03-13
• Status Verified: 2023-06
• Primary Completion: 2024-04-12
• Study Completion: 2024-07-13
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (Virtual Family-Centered Rounds [FCR])	Virtual family-centered rounds (FCR)	Virtual FCR-arm parents/guardians (referred to as "parents" hereafter) will have the option use have the option to use telehealth for virtual rounds. Parents can participate in virtual FCR as much, or as little, as they choose. Parents also will have the option to attend FCR in person or to not attend FCR.

Primary Outcome Measures

Name	Time	Method
Parent FCR attendance	Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)	Defined at the family unit level, accounting for the possibility of multiple enrolled infants per family and variable lengths of stay for each infant. The investigators will compute the total number of possible weekday FCR encounters per family (the 'denominator') and the number of those for which at least one parent was present virtually or in-person (the 'numerator'). Obtained from FCR weekday observations.

Secondary Outcome Measures

Name	Time	Method
Breastmilk feeding	Day 0/90 (post-NICU discharge)	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).
NICU length of stay	Day 0 (post-NICU discharge)	Unit of measure: days in NICU. Obtained from electronic health record.
Parent Activation	Day 0 (post-NICU discharge)	Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)
Parent experience	Day 0 (post-NICU discharge)	Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).
Family-Centered Care	Day 0 (post-NICU discharge)	Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)
Parent health-related quality of life	Day 0/30/60/90 (post-NICU discharge)	Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)
Postnatal growth failure (categorical)	Day 0 (post-NICU discharge)	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.
Postnatal growth failure (dichotomous)	Day 0 (post-NICU discharge)	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.

Trial Locations

Locations (1)

The Regents of the University of California, Davis; 🇺🇸 Sacramento, California, United States