🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT05286983
Recruiting Observational

Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project

NCT05286983 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2020-10-01
Last updated
2025-03-30

Condition(s) studied

Family Centered Care

Investigational drug(s) / intervention(s)

Family Centred Care (FCC) interventions as potentially better practices (PBPs)

Family Centred Care (FCC) interventions as potentially better practices (PBPs): 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

Study 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.

Eligibility

Sex
ALL
Min age
1 Minute
Max age
14 Days
Healthy volunteers
Accepted
Inclusion Criteria: * ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g * biparental (or guardian) written informed consent Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Mihatsch Walter Ulm Baden-Wurttemberg Active Not Recruiting
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany Giessen Hesse Recruiting

More University of Giessen trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05286983 on ClinicalTrials.gov ↗ ← All trials in Germany