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Search / Trial NCT05286983

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

Launched by UNIVERSITY OF GIESSEN · Mar 9, 2022

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how improving family-centered care in the Neonatal Intensive Care Unit (NICU) can benefit preterm infants, their parents, and the staff who care for them. Family-centered care means involving families in the care process and making sure they have the support they need. The study will introduce new practices that focus on creating a better NICU environment, training staff, educating parents, and providing emotional support to families. Researchers will then assess how these changes affect the well-being of the infants, the parents, and the staff over time.

To be part of this study, infants must be born prematurely (at or before 32 weeks of pregnancy) or weigh 1500 grams or less at birth. Parents or guardians will need to provide written consent for their participation. During the study, families can expect to receive the enhanced support and resources related to their infant’s care. It's important to note that infants with severe birth defects or those whose families have chosen not to pursue full life support are not eligible for this trial. Overall, this study aims to create a more supportive environment for everyone involved in the care of these vulnerable infants.

Gender

ALL

Eligibility criteria

  • 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

About University Of Giessen

The University of Giessen, a prominent research institution in Germany, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its expertise in various fields, including medicine, pharmacology, and public health, to conduct rigorous studies aimed at improving patient outcomes. Committed to maintaining the highest ethical standards and regulatory compliance, the University of Giessen fosters a research environment that encourages scientific inquiry and the translation of findings into clinical practice, ultimately contributing to the advancement of healthcare and therapeutic strategies.

Locations

Ulm, Baden Wuerttemberg, Germany

Giessen, Hesse, Germany

Patients applied

0 patients applied

Trial Officials

Rahel Schuler

Principal Investigator

Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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