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Recruiting NCT05286983

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

Trial Parameters

Condition Family Centered Care
Sponsor University of Giessen
Study Type OBSERVATIONAL
Phase N/A
Enrollment 495
Sex ALL
Min Age 1 Minute
Max Age 14 Days
Start Date 2020-10-01
Completion 2026-07-01
Interventions
Family Centred Care (FCC) interventions as potentially better practices (PBPs)

Brief 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 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

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