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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-14
SponsorUniversity of Giessen

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

495 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Sponsors and collaborators

University of Giessen

Lead sponsor

University of Ulm

Collaborator