Assessing outcomes of family-centered care for preterm infants and their parents
Official title: Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care
Run by University of Giessen · NCT05286983 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 1 Minute to 14 Days |
| Sex | All |
| Enrollment | 495 (estimated) |
| Sponsor | University of Giessen Academic / other |
| Locations | 2 sites (Ulm, Baden-Wurttemberg and 1 other locations) |
| Status | Recruiting |
| Started | October 1, 2020 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2026 |
| Registry record updated | March 30, 2025 |
| Trial ID | NCT05286983 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe congenital anomalies or those whose parents have severe psychiatric diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown positive outcomes with family-centered care approaches, indicating potential for success in this study as well.
Who can join: the full rules
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 it's running
-
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
Giessen, Hesse, Germany Recruiting -
Mihatsch Walter
Ulm, Baden-Wurttemberg, Germany Active not 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Family-centred care in UK inpatient wards
This study tests how family involvement in adult internal medicine wards is understood and experienced by patients, their families, and nurses at Milton Keynes University Hospital.
-
Family-integrated newborn care for preterm and low-birth-weight babies
This project will try training and integrating parents into hospital care for preterm and low-birth-weight newborns in Tigray to see if it shortens hospital stays and improves outcomes.
-
Involving families in ICU rounds to improve care engagement
This study tests if including families in rounds at adult ICUs can help them feel more involved and satisfied with the care their loved ones receive.
-
Improving family engagement in critical care settings
This study is testing a new tool to see if it helps families of ICU patients feel more involved and satisfied with their loved one's care.
-
Improving Family Centered Care in the NICU
This study is testing a new approach to involve parents more in their newborn's care in the NICU to see if it helps reduce their anxiety and makes them feel more ready for discharge.
-
Early physiotherapy to improve motor optimality in at-risk infants
This trial will test whether starting a targeted physiotherapy program early improves motor movement scores in infants born preterm or who had serious neonatal complications.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.