About this trial
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
Qualifiers
≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
biparental (or guardian) written informed consent
Disqualifiers
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
Trial design
Treatments tested in this trial
- Family Centred Care (FCC) interventions as potentially better practices (PBPs)
Treatment groups
11
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of Giessen
Lead sponsor
University of Ulm
Collaborator