Safety and Parental Satisfaction With Early Discharge of Preterm Infants on Nasogastric Tube Feeding and Outpatient Clinic Follow-Up.
Rahel Schuler, Harald Ehrhardt, Walter A Mihatsch
https://pubmed.ncbi.nlm.nih.gov/32984217Actively Recruiting
Led by University of Giessen · Updated on 2025-03-30
495
Participants Needed
2
Research Sites
N/A
Total Duration
U
University of Giessen
Lead Sponsor
U
University of Ulm
Collaborating Sponsor
Researchers are studying the effects of enhanced Family Centered Care (FCC) practices on preterm infants born at or before 32 weeks of gestation and/or weighing 1500 grams or less, along with their parents and NICU staff. This longitudinal cohort study aims to assess how introducing additional FCC elements influences infant health, parental mental health, and staff satisfaction over time. The study is conducted at a single center and explores the interaction between infant outcomes, parent well-being, and staff experiences within the NICU environment. The study begins with a baseline period, after which new FCC interventions are gradually introduced every six months. These interventions include staff training, parent education, psychosocial support for families, and improvements to the NICU environment to promote closeness between parents and infants. A focus group of nurses and healthcare professionals regularly decides on new care practices, which are then shared with the larger team through workshops and hands-on teaching. Participants are followed with periodic evaluations until the infants reach 24 months corrected age. Researchers collect data on various outcomes such as length of hospital stay, neonatal morbidities, growth, feeding milestones, neurodevelopment, parental anxiety, depression, stress, satisfaction, and staff job satisfaction. The study uses quality improvement methods to monitor changes, and the total recruitment period spans 5.5 years with long-term follow-up to assess the effects of the FCC enhancements.
CONDITIONS
Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants are observed during the baseline period before the introduction of Family Centred Care (FCC) interventions.
Periodic assessments during hospital stay
Duration - Up to 5 years of stepwise FCC intervention periods
Family Centred Care (FCC) interventions are gradually introduced every 6 months, including staff training, parent education, psychosocial support, and improvements to the neonatal intensive care unit environment.
Regular assessments during hospital stay and follow-up visits until 24 months corrected age
Duration - Up to 2 years after discharge
Participants are followed up to monitor infant neurodevelopment, parental mental health, and staff satisfaction up to 24 months corrected age after hospital discharge.
Periodic follow-up visits until 24 months corrected age
Total: 2 locations
1
Mihatsch Walter
Ulm, Baden-Wurttemberg, Germany, 89231
Active, Not Recruiting
2
Department of General Pediatrics and Neonatology, Justus- Liebig- University, Feulgenstrasse 12, D-35392 Giessen, Germany
Giessen, Hesse, Germany, 35390
Actively Recruiting
R
Rahel Schuler, Dr.
H
Harald Ehrhardt, Prof.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
11
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Rahel Schuler, Harald Ehrhardt, Walter A Mihatsch
https://pubmed.ncbi.nlm.nih.gov/32984217Rahel Schuler, Lea Woitschitzky, Carola Eiben...
https://pubmed.ncbi.nlm.nih.gov/37420180