Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project
1 other identifier
observational
495
1 country
2
Brief Summary
This prospective single centre longitudinal cohort study enrols preterm infants ≤32+0 weeks of gestation and/or birthweight ≤1500g and their parents. Following a baseline period additional Family Centred Care elements are introduced as potentially better practices, these elements focus on four areas: the NICU (Neonatal Intensive Care Unit) environment, staff training, parental education and psychosocial support to the families. The effect of the implementation of additional Family Centred Care elements on infant, parent and staff outcomes are assessed. The parallel data collection enables to study the interrelation between these three important areas of research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
March 30, 2025
March 1, 2025
5.8 years
February 23, 2022
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Length of hospital stay
Length of hospital stay measured by corrected gestational age at discharge
5.5years
Secondary Outcomes (29)
Key neonatal morbidities
5.5years
Weight gain
5.5years
Weight Z-Score
5.5years
Weight
5.5years
Length Z-Score
5.5years
- +24 more secondary outcomes
Study Arms (11)
K0 - baseline cohort
45 preterm infants and their parents (average number of patient admissions per 6 months during the last 5 years)
K1 - 1st intervention cohort
All preterm infants and their parents enrolled during the first 6 months period after completion of the baseline cohort and who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K2 - 2nd intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K3 - 3rd intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K4 - 4th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K5 - 5th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K6 - 6th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K7 - 7th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K8 - 8th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K9 - 9th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K10 - 10th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
Interventions
After the previous period, additional Family Centred Care (FCC) elements will be introduced gradually every 6 months, covering staff training, parent education, psychosocial support for families, and last but not least, the neonatal intensive care unit environment. The focus group consisting of nurses and healthcare professionals will meet regularly and will decide on new FCC interventions as potentially better practices (PBPs). New additional PBPs will be disseminated into the greater team through workshops, hands-on teaching, displays, etc. Potential PBPs for our department enclose: Parent participation on rounds Parent skill self-assessment Parent-to-parent support Regular staff education Improvement of psychosocial support Improvement of neonatal unit surroundings to promote parent-infant-closeness
Eligibility Criteria
The study population consists of inborn and outborn preterm infants of ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g who are admitted to the Level 3 NICU and their parents
You may qualify if:
- ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
- biparental (or guardian) written informed consent
You may not qualify if:
- severe congenital anomalies (e.g. cyanotic heart disease, severe lung hypoplasia, congenital diaphragmatic hernia)
- decision not to provide full life support
- decision for palliative care before study entry
- parents with severe psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Giessenlead
- University of Ulmcollaborator
Study Sites (2)
Mihatsch Walter
Ulm, Baden-Wurttemberg, 89231, Germany
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
Giessen, Hesse, 35390, Germany
Related Publications (2)
Schuler R, Ehrhardt H, Mihatsch WA. Safety and Parental Satisfaction With Early Discharge of Preterm Infants on Nasogastric Tube Feeding and Outpatient Clinic Follow-Up. Front Pediatr. 2020 Aug 25;8:505. doi: 10.3389/fped.2020.00505. eCollection 2020.
PMID: 32984217BACKGROUNDSchuler R, Woitschitzky L, Eiben C, Beck J, Jagers A, Windhorst A, Kampschulte B, Petzinger J, Waitz M, Kilsdonk MOR, Neubauer BA, Zimmer KP, Ehrhardt H, Brosig B, Mihatsch WA. Multidimensional assessment of infant, parent and staff outcomes during a family centered care enhancement project in a tertiary neonatal intensive care unit: study protocol of a longitudinal cohort study. BMC Pediatr. 2023 Jul 7;23(1):344. doi: 10.1186/s12887-023-04165-0.
PMID: 37420180DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rahel Schuler
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Neonatology
Study Record Dates
First Submitted
February 23, 2022
First Posted
March 18, 2022
Study Start
October 1, 2020
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
March 30, 2025
Record last verified: 2025-03