RecruitingNCT05286983

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

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


Sponsor

University of Giessen

Enrollment

495 participants

Start Date

Oct 1, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 1 MinuteMax Age: 14 Days

Inclusion Criteria2

  • ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
  • biparental (or guardian) written informed consent

Exclusion Criteria4

  • 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

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Interventions

BEHAVIORALFamily 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


Locations(2)

Mihatsch Walter

Ulm, Baden-Wurttemberg, Germany

Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany

Giessen, Hesse, Germany

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NCT05286983


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