Actively Recruiting

Age: 1Minute - 14Days
All Genders
Healthy Volunteers
ID05286983

Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project in a Tertiary Neonatal Intensive Care

Led by University of Giessen · Updated on 2025-03-30

495

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Giessen

Lead Sponsor

U

University of Ulm

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Multidimensional Assessment of Infant, Parent and Staff Outcomes During a Family Centered Care Enhancement Project

Who Can Participate

Age: 1Minute - 14Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Born at or before 32+0 weeks of gestation and/or birthweight 1500 g or less
  • Biparental (or guardian) written informed consent
Not Eligible

You will not qualify if you...

  • Severe congenital anomalies such as cyanotic heart disease, severe lung hypoplasia, or congenital diaphragmatic hernia
  • Decision not to provide full life support
  • Decision for palliative care before study entry
  • Parents with severe psychiatric disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Observation

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

Outpatient Treatment

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

Long-term Monitoring

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

Trial Site Locations

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

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Research Team

R

Rahel Schuler, Dr.

H

Harald Ehrhardt, Prof.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

11

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Published Research Related To This Trial

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/32984217

Multidimensional assessment of infant, parent and staff outcomes during a family centered care enhancement project in a tertiary neonatal intensive care unit: study protocol of a longitudinal cohort study.

Rahel Schuler, Lea Woitschitzky, Carola Eiben...

https://pubmed.ncbi.nlm.nih.gov/37420180