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Assessment of an Innovative Air Mattress on Critically Ill Infants

NCT06425068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-01-13

No results posted yet for this study

Summary

The permanent bedding of critically ill neonates and infants in the pediatric intensive care unit (PICU) for an extended amount of time can result in the development of pressure injuries (PI). PIs can form due to high and permanent local interface pressure induced by contact with bed surfaces or other medical devices. The currently used state-of-the-art support systems consist of conventional foam mattresses. In this study, the investigators explore the effect of a newly developed air mattress with regard to contact are and reduction in the average interface pressure in infants assigned to the pediatric intensive care unit of the childrens hospital in Zurich.

Conditions

  • Skin Abnormalities
  • Skin; Injury, Superficial
  • Skin; Ulcer, Decubitus

Interventions

DEVICE

Exposure of the patient to a novel air mattress.

see information provided in the "Arms" section (experimental)

DEVICE

Exposure of the patient to a conventional foam mattress.

see information provided in the "Arms" section (active comparator)

Sponsors & Collaborators

  • University Children's Hospital, Zurich

    collaborator OTHER

  • Simon Annaheim

    lead OTHER

Principal Investigators

  • Barbara Brotschi, Prof · Universitäts-Kinderspital Zürich, Zurich

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Days
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2024-09-10
Completion
2024-09-10

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425068 on ClinicalTrials.gov