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.
≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
biparental (or guardian) written informed consent
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
The study population consists of inborn and outborn preterm infants of ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g who are admitted to the Level 3 NICU and their parents
Cohort
Prospective
Family Centred Care (FCC) interventions as potentially better practices (PBPs)
BehavioralAfter the previous period, additional Family Centred Care (FCC) elements will be introduced gradually every 6 months, covering staff training, parent education, psychosocial support for families, and last but not least, the neonatal intensive care unit environment. The focus group consisting of nurses and healthcare professionals will meet regularly and will decide on new FCC interventions as potentially better practices (PBPs). New additional PBPs will be disseminated into the greater team through workshops, hands-on teaching, displays, etc. Potential PBPs for our department enclose: Parent participation on rounds Parent skill self-assessment Parent-to-parent support Regular staff education Improvement of psychosocial support Improvement of neonatal unit surroundings to promote parent-infant-closeness
11
Treatment groupsSee each treatment group below.
Length of hospital stay
Length of hospital stay measured by corrected gestational age at discharge
Key neonatal morbidities
Number of Participants with Bronchopulmonary Dysplasia (BPD), Number of Participants with Intraventricular Hemorrhage (IVH) Grade III-IV, Number of Participants with Periventricular Leucomalacia (PVL), Number of Participants with Necrotizing Enterocolitis (NEC) stage 2 or stage 3, Number of Participants with Retinopathia of Prematurity (ROP) stage 3 or greater or treatment
Weight gain
weight gain (g/kg/d) from admission to 36+0/40+0 weeks (corrected age)
Weight Z-Score
Z- Scores for weight at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Weight
Weight in Gram at 36+0, 40+0, 3, 12 and 24 months (corrected age)
Click on the lead sponsor to view all of their trials.
University of Giessen
Lead sponsor
University of Ulm
Collaborator
