Assessing outcomes of family-centered care for preterm infants and their parents
Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care
This study is testing if improved family-centered care in the NICU helps preterm babies and their parents feel better and do better as they grow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 495 (estimated) |
| Ages | 1 Minute to 14 Days |
| Sex | All |
| Sponsor | University of Giessen Academic / other |
| Locations | 2 sites (Ulm, Baden-Wurttemberg and 1 other locations) |
| Trial ID | NCT05286983 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on preterm infants born at or before 32 weeks of gestation or weighing 1500 grams or less, along with their parents. It aims to evaluate the impact of enhanced Family Centered Care (FCC) practices in the Neonatal Intensive Care Unit (NICU) over a 5.5-year period. The study will introduce additional FCC elements, including staff training, parental education, and psychosocial support, and will track outcomes for infants, parents, and staff through periodic follow-ups until the infants reach 24 months of corrected age. The goal is to understand how these practices affect the well-being of all parties involved.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at or before 32 weeks of gestation or with a birth weight of 1500 grams or less, along with their parents.
Not a fit: Patients with severe congenital anomalies or those whose parents have severe psychiatric diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the health outcomes and emotional well-being of preterm infants and their families.
How similar studies have performed: Other studies have shown positive outcomes with family-centered care approaches, indicating potential for success in this study as well.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ulm, Baden-Wurttemberg and 1 other locations
- Mihatsch Walter — Ulm, Baden-Wurttemberg, Germany (Active_not_recruiting)
- Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany — Giessen, Hesse, Germany (Recruiting)
Study contacts
- Principal investigator: Rahel Schuler — Department of General Pediatrics and Neonatology, Justus- Liebig- University, Giessen, Germany
- Study coordinator: Rahel Schuler, Dr.
- Email: rahel.schuler@paediat.med.uni-giessen.de
- Phone: +4964198558821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.