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

Recruitingn/aAges 1 Minute - 14 DaysAllUniversity of Giessen
NCT05286983 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Family Centred Care (FCC) interventions as potentially better practices (PBPs)
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Where

2 sites
Mihatsch Walter
Ulm, Germany
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
Giessen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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