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Completed

NCT Number: NCT06171867

PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring

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

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Key information

Conditions

Neonatal Respiratory Distress Lung Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

12 hour–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PNEUMACRIT

Device

Monitoring of breathing

Primary outcomes

  1. Proportion (%) of recording time with high quality EIT-signal

    Time frame: 6-24 hours

    Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration

Secondary outcomes

  1. Staff and parent questionnaires

    Time frame: 48 hours

    After the study period, the patient parents and nurses will give feedback on the device and its feasibility with a structured questionnaire including also free text fields

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Middlesex University

Registry information

Official study title

Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability

Acronym: PNEUMACRIT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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