Clinical Trial

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

Recruiting

Record status

This record was last updated March 30, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2022-03-09; most recent amendment 2025-03-25.

Trial Details

NCT Number	NCT05286983
Lead Sponsor	University of Giessen Collaborators: University of Ulm
Conditions	Family Centered Care
Enrollment	495 participants
Start Date	2020-10-01
Primary Completion	2026-07-01 (estimated)
Study Completion	2026-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-30