Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05762835
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2023-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Neonatal Intensive Care Unit Virtual Family-Centered Rounds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rosenthal@ucdavis.edu', 'phone': '9167344719', 'title': 'Dr. Jennifer Rosenthal', 'organization': 'University of California at Davis'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '13 months', 'description': "Adverse event data were collected and monitored for infant participants only. Adverse events were not assessed or recorded for parent participants as part of the study's safety monitoring.", 'eventGroups': [{'id': 'EG000', 'title': 'Intervention (Virtual Family-Centered Rounds [FCR])', 'description': '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.\n\nVirtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child\'s care.\n\nThe NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).', 'otherNumAtRisk': 342, 'deathsNumAtRisk': 342, 'otherNumAffected': 0, 'seriousNumAtRisk': 342, 'deathsNumAffected': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control (Usual Care)', 'description': 'Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 0, 'seriousNumAtRisk': 168, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Parent FCR Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '322', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention (Virtual Family-Centered Rounds [FCR])', 'description': '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.\n\nVirtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child\'s care.\n\nThe NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).'}, {'id': 'OG001', 'title': 'Control (Usual Care)', 'description': 'Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.51', 'upperLimit': '0.61'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.16'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)', 'description': "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.", 'unitOfMeasure': 'proportion of encounters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parent Experience', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Family-Centered Care', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Parent Activation', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Parent Health-related Quality of Life', 'timeFrame': 'Day 0/30/60/90 (post-NICU discharge)', 'description': 'Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'NICU Length of Stay', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: days in NICU. Obtained from electronic health record.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Breastmilk Feeding', 'timeFrame': 'Day 0/90 (post-NICU discharge)', 'description': '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).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Postnatal Growth Failure (Dichotomous)', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Postnatal Growth Failure (Categorical)', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Neonatal Growth Velocity', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events and Errors', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '30-day Revisit', 'timeFrame': 'Day 30 (post-NICU discharge)', 'description': 'Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '30-day Readmission', 'timeFrame': 'Day 30 (post-NICU discharge)', 'description': 'Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Temperature Instability', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Central Line-associated Bloodstream Infection', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Central Line Days', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Antibiotic Days', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention (Virtual Family-Centered Rounds [FCR])', 'description': '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.\n\nVirtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child\'s care.\n\nThe NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).'}, {'id': 'FG001', 'title': 'Control (Usual Care)', 'description': 'Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Family units enrolled and randomized. 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). Randomized 325 families (345 infants) to the intervention arm.', 'groupId': 'FG000', 'numUnits': '325', 'numSubjects': '345'}, {'comment': 'Family units enrolled and randomized. 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). Randomized 161 families (169 infants) to the control arm.', 'groupId': 'FG001', 'numUnits': '161', 'numSubjects': '169'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Outcomes data analyzed for 322 families (342 infants, 430 parents) in the intervention arm.', 'groupId': 'FG000', 'numUnits': '322', 'numSubjects': '342'}, {'comment': 'Outcomes data analyzed for 160 families (168 infants, 219 parents) in the control arm.', 'groupId': 'FG001', 'numUnits': '160', 'numSubjects': '168'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'families', 'preAssignmentDetails': '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).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '772', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '1159', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention (Virtual Family-Centered Rounds [FCR])', 'description': '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.\n\nVirtual family-centered rounds (FCR): Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child\'s care.\n\nThe NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).'}, {'id': 'BG001', 'title': 'Control (Usual Care)', 'description': 'Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '772', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '1159', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '342', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '649', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '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).'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Infants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.05', 'groupId': 'BG000'}, {'value': '0.01', 'spread': '0.04', 'groupId': 'BG001'}, {'value': '0.01', 'spread': '0.04', 'groupId': 'BG002'}]}]}, {'title': 'Parent 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.1', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '31.7', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '5.8', 'groupId': 'BG002'}]}]}, {'title': 'Parent 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.5', 'spread': '7.3', 'groupId': 'BG000'}, {'value': '34.3', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '33.8', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The overall number of baseline participants includes all individuals enrolled in the study (infants and their parents). Each baseline row reports data from a specific sub-population: infants, Parent 1s, and Parent 2s. The number analyzed in each row reflects the actual number of participants in that subgroup only.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}, {'title': 'Parent 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Parent 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Parent participants included those with unknown sex'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': 'Parent 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Parent 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '510 (infants) + 361 (parent 1) + 288 (parent 2) = 1159 total'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '772', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '1159', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '772', 'groupId': 'BG000'}, {'value': '387', 'groupId': 'BG001'}, {'value': '1159', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Overall # baseline participants is 322 intervention families (342 infants, 242 P1s, 188 P2s = 772 total) \\& 160 control families (168 infants, 119 P1s, 100 P2s = 387 total). Each family consisted of different #s of infants (e.g., twins) and different #s of parents (i.e., 1 to 2 parents/guardians per family) participants.\n\nBaseline data includes (a) enrolled infants plus (b) parents.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-07', 'size': 755347, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-12T16:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 514}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2023-02-17', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-30', 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neonatal Growth Velocity', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.'}, {'measure': 'Adverse Events and Errors', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.'}, {'measure': '30-day Revisit', 'timeFrame': 'Day 30 (post-NICU discharge)', 'description': 'Defined as post-discharge revisits to any emergency department. Obtained from electronic health record and parent-reported survey.'}, {'measure': '30-day Readmission', 'timeFrame': 'Day 30 (post-NICU discharge)', 'description': 'Defined as post-discharge unplanned readmissions to any hospital. Obtained from electronic health record and parent-reported survey.'}, {'measure': 'Temperature Instability', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Dichotomous variable defined as any occurrence of a temperature below 36 degrees C during the NICU hospitalization. Obtained from electronic health record.'}, {'measure': 'Central Line-associated Bloodstream Infection', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.'}, {'measure': 'Central Line Days', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.'}, {'measure': 'Antibiotic Days', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Parent FCR Attendance', 'timeFrame': 'Length of neonatal intensive care unit [NICU] stay (assessed up to 396 days)', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Parent Experience', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: mean score; Measure/Tool: Emergency Department CAHPS (Consumer Assessment of Healthcare Providers and Systems) (parent survey, 2 items measuring overall experience).'}, {'measure': 'Family-Centered Care', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: mean score; Measure/Tool: Family-Centered Care Experience (FACCE) (parent survey)'}, {'measure': 'Parent Activation', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: mean score; Measure/Tool: Parent-Patient Activation Measure (P-PAM) (parent survey)'}, {'measure': 'Parent Health-related Quality of Life', 'timeFrame': 'Day 0/30/60/90 (post-NICU discharge)', 'description': 'Unit of measure: mean score. Measure/Tool: PedsQL Family Impact Module (parent survey)'}, {'measure': 'NICU Length of Stay', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': 'Unit of measure: days in NICU. Obtained from electronic health record.'}, {'measure': 'Breastmilk Feeding', 'timeFrame': 'Day 0/90 (post-NICU discharge)', 'description': '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': 'Postnatal Growth Failure (Dichotomous)', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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': 'Postnatal Growth Failure (Categorical)', 'timeFrame': 'Day 0 (post-NICU discharge)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatrics', 'Neonatal Intensive Care Units', 'Neonate', 'Clinical Trial', 'Telemedicine', 'Patient-Centered Care', 'Patient Reported Outcome Measures'], 'conditions': ['Pediatric Disorder', 'Neonatal Disease']}, 'referencesModule': {'references': [{'pmid': '37194089', 'type': 'DERIVED', 'citation': 'Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual family-centered hospital rounds in the neonatal intensive care unit: protocol for a cluster randomized controlled trial. Trials. 2023 May 16;24(1):331. doi: 10.1186/s13063-023-07340-x.'}, {'pmid': '37131689', 'type': 'DERIVED', 'citation': 'Rosenthal JL, Tancredi DJ, Marcin JP, Ketchersid A, Horath ET, Zerda EN, Bushong TR, Merriott DS, Romano PS, Young HM, Hoffman KR. Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: Protocol for a Cluster Randomized Controlled Trial. Res Sq [Preprint]. 2023 Apr 17:rs.3.rs-2644794. doi: 10.21203/rs.3.rs-2644794/v1.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Enrolling family units (which consists of INFANTS and PARENTS \\[SURVEYS\\]):\n\nINFANT Inclusion\n\n* Infants aged less than 365 days who are admitted to the NICU\n* Have at least one adult parent or guardian with English proficiency\n\nINFANT Exclusion\n\n* Have restrictions placed by child protective services, including visitation restrictions or restricted access to patient information\n* Infants with a previous NICU admission (and enrollment) during the trial period\n\nPARENTS \\[SURVEYS\\] Inclusion\n\n* Parents/guardians of the eligible infants (described above)\n* Age 18 years and older\n\nPARENTS \\[SURVEYS\\] Exclusion\n\n* Age less than 18 years\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT05762835', 'briefTitle': 'Neonatal Intensive Care Unit Virtual Family-Centered Rounds', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: a Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1764454'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Virtual Family-Centered Rounds [FCR])', 'description': '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.', 'interventionNames': ['Behavioral: Virtual family-centered rounds (FCR)']}, {'type': 'NO_INTERVENTION', 'label': 'Control (Usual Care)', 'description': 'Usual care-arm parents will receive usual care. Usual care-arm parents will have the option to attend FCR in person or to not attend FCR.'}], 'interventions': [{'name': 'Virtual family-centered rounds (FCR)', 'type': 'BEHAVIORAL', 'description': "Parents will be given the option to join FCR virtually or in-person; this intervention is changing the behavior of how providers deliver healthcare and how parents engage in their child's care.\n\nThe NICU team members will use a computer with a speaker and pan-tilt-zoom camera, mounted on a stand with wheels to launch telehealth connections using the secure application called ExtendedCare. From within this telehealth connection, a NICU team member will send an electronic message (e.g. via text or email) to the subscribed parent(s) and wait for the parent to join the visit to establish a secure videoconference. The message to the parent includes a link that can be clicked to open a browser that allows the parent to join the telehealth visit. FCR will then proceed in usual fashion with the NICU team members and - if in attendance - parent(s).", 'armGroupLabels': ['Intervention (Virtual Family-Centered Rounds [FCR])']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'The Regents of the University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Jennifer L Rosenthal, MD, MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}