NCT05286983 Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project
| NCT ID | NCT05286983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Giessen |
| Condition | Family Centered Care |
| Study Type | OBSERVATIONAL |
| Enrollment | 495 participants |
| Start Date | 2020-10-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 495 participants in total. It began in 2020-10-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Rahel Schuler
PRINCIPAL INVESTIGATOR
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany
Frequently Asked Questions
Who can join the NCT05286983 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 14 Days, studying Family Centered Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05286983 currently recruiting?
Yes, NCT05286983 is actively recruiting participants. Contact the research team at rahel.schuler@paediat.med.uni-giessen.de for enrollment information.
Where is the NCT05286983 trial being conducted?
This trial is being conducted at Ulm, Germany, Giessen, Germany.
Who is sponsoring the NCT05286983 clinical trial?
NCT05286983 is sponsored by University of Giessen. The principal investigator is Rahel Schuler at Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany. The trial plans to enroll 495 participants.