ClinicalTrials.Veeva

Menu

PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

U

University of Oulu

Status

Completed

Conditions

Neonatal Respiratory Distress

Treatments

Device: PNEUMACRIT

Study type

Interventional

Funder types

Other

Identifiers

NCT06171867
EETTMK: 73/2021

Details and patient eligibility

About

The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.

Full description

Electrical impedance tomography is a noninvasive monitoring tool for neonatal lung aeration and breathing. This feasibility study will assess the usability of a new PNEUMACRIT electrode belt in clinical environment.

Enrollment

20 patients

Sex

All

Ages

12 hours to 6 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Inpatient at Oulu University Hospital PICU or NICU
  • Gestational age at birth over 32 weeks
  • Weight 2000-5000g
  • Postnatal age > 12 hours
  • Written informed consent from the parents of legal representative
  • Non-invasive monitoring of oxygen saturation and ECG

Exclusion criteria

  • Postmenstrual age < 32 weeks
  • Weight at time of the study < 2000g or > 5000g
  • Chest skin lesion preventing safe use of the electrode belt
  • Recent chest surgery within the past 7 days (e.g. thoracotomy)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Feasibility of the PNEUMACRIT belt
Experimental group
Description:
Neonates will be monitored with a PNEUMACRIT electrode belt for 6 to 24 hours. After the study period, patient parents and nurses will give feedback.
Treatment:
Device: PNEUMACRIT

Trial contacts and locations

1

Loading...

Central trial contact

Miikka Tervonen, MD; Merja Kallio, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems