Actively Recruiting

Phase Not Applicable
Age: 28Days - 5Years
All Genders
ID06977152

Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in Children's Heads A Randomised Controlled Study

Led by Koç University · Updated on 2026-03-31

32

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

K

Koç University

Lead Sponsor

K

Koc University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are comparing two types of head and neck support devices—the fluidized positioner and the memory foam pillow—to see which is more effective at preventing pressure injuries in young children in the pediatric intensive care unit (PICU). The study specifically focuses on children aged 28 days to 5 years who require mechanical ventilation and are immobile. The goal is to understand differences in pressure injury rates, pressure distribution, and injury locations on the head using these two devices. Children in the study will be randomly assigned to receive either a fluidized positioner or a memory foam pillow placed under their head and neck immediately after starting mechanical ventilation support in the PICU. The study is designed as a randomized controlled trial with double blinding to compare these two devices. Both groups will be monitored over a period of up to 14 days while using their assigned support surface. Throughout the study, researchers will monitor the development of pressure injuries on the head from the start of mechanical ventilation up to 14 days. Pressure measurements on the first, seventh, and fourteenth days of device use will also be recorded to assess pressure distribution. Participants will be closely observed to collect sufficient data, and any new health conditions affecting pressure injury risk will be noted. The total participation duration for each child is up to 14 days.

CONDITIONS

Brief Title

Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head

Who Can Participate

Age: 28Days - 5Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Being treated in the pediatric intensive care unit
  • Receiving mechanical ventilation
  • Being immobile
  • Age between 28 days and 5 years
  • Having consent for participation in the study
Not Eligible

You will not qualify if you...

  • Having surgical intervention in the head region
  • Parents wanting to leave at any stage of the project
  • Having hydrocephalus or burns on the head
  • Having pressure injuries on admission to hospital
  • Existing dermatologic diseases affecting the skin or connective tissue
  • Development of a new condition during the intervention that significantly affects pressure injury risk
  • Inability to obtain sufficient data during the study (e.g., patient transfer)

AI-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)

Implementation

Duration - Up to 14 days during mechanical ventilation support

Participants receive either a fluidized positioner or a memory foam pillow placed under their head and neck immediately after starting mechanical ventilation support in the pediatric intensive care unit.

Visits on Day 1, Day 7, and Day 14 for pressure measurements

Trial Site Locations

Total: 1 location

1

Koç University Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye), 34010

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Research Team

E

Enes Şimşek, MSc. PhD(c)

R

Remziye Semerci, PhD.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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