Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 14 days
Healthy Volunteers: t
View:
• ≤32+0 weeks of gestational age (GA) and/or birthweight ≤1500g
• biparental (or guardian) written informed consent
Locations
Other Locations
Germany
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
RECRUITING
Giessen
Mihatsch Walter
ACTIVE_NOT_RECRUITING
Ulm
Contact Information
Primary
Rahel Schuler, Dr.
rahel.schuler@paediat.med.uni-giessen.de
+4964198558821
Backup
Harald Ehrhardt, Prof.
harald.ehrhardt@paediat.med.uni-giessen.de
Time Frame
Start Date: 2020-10-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 495
Treatments
K0 - baseline cohort
45 preterm infants and their parents (average number of patient admissions per 6 months during the last 5 years)
K1 - 1st intervention cohort
All preterm infants and their parents enrolled during the first 6 months period after completion of the baseline cohort and who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K2 - 2nd intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K3 - 3rd intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K4 - 4th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K5 - 5th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K6 - 6th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K7 - 7th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K8 - 8th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K9 - 9th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
K10 - 10th intervention cohort
All preterm infants and their parents enrolled during the 6 months period after the previous 6 months period who are treated according to prespecified Family Centred Care interventions implemented as Potentially Better Practices.
Related Therapeutic Areas
Sponsors
Leads: University of Giessen
Collaborators: University of Ulm