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

NCT05286983 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 495

Last updated 2025-03-30

No results posted yet for this 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.

Conditions

  • Family Centered Care

Interventions

BEHAVIORAL

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

Sponsors & Collaborators

  • University of Ulm

    collaborator OTHER

  • University of Giessen

    lead OTHER

Principal Investigators

  • Rahel Schuler · Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany

Eligibility

Min Age
1 Minute
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286983 on ClinicalTrials.gov