Status:
RECRUITING
Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project
Lead Sponsor:
University of Giessen
Collaborating Sponsors:
University of Ulm
Conditions:
Family Centered Care
Eligibility:
All Genders
1-14 years
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 Cent...
Detailed Description
Background: The therapeutic advances and progress in the care for preterm infants have enabled the regular survival of more and more immature infants. However, the high burden of lifelong sequelae fol...
Eligibility Criteria
Inclusion
- ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
- biparental (or guardian) written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT05286983
Start Date
October 1 2020
End Date
July 1 2026
Last Update
March 30 2025
Active Locations (2)
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1
Mihatsch Walter
Ulm, Baden-Wurttemberg, Germany, 89231
2
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
Giessen, Hesse, Germany, 35390