Actively Recruiting

Age: 1Minute - 14Days
All Genders
Healthy Volunteers
NCT05286983

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

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

495

Participants Needed

2

Research Sites

299 weeks

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

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.

CONDITIONS

Official 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 gestational age and/or birthweight of 1500 grams 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

Complete this quick 3-step screening to check your eligibility

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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.

CONTACT

H

Harald Ehrhardt, Prof.

CONTACT

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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