Neonatal Respiratory DistressPNEUMACRITNCT06171867
PNEUMACRIT Device for Neonatal Cardio Respiratory Monitoring
A study testing PNEUMACRIT in people with Neonatal Respiratory Distress, run by University of Oulu at 1 site in Finland.
Trial summary
The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study. Read more about this study
- Who is it for?
- Ages 12 hours to 6 months
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- PNEUMACRIT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 24 Nov 2023to 25 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 hours to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability
The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.
Read the detailed 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.
- Conditions
- Neonatal Respiratory Distress
- Being tested
- PNEUMACRIT
- Keywords
- Electrical impedance tomography, neonate
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEUMACRITDevice
Monitoring of breathing
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of the PNEUMACRIT belt | Experimental | 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. Receives: Device: PNEUMACRIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of recording time with high quality EIT-signal
Proportion of time that the collected EIT signal is accurate enough for reliable image reconstruction and observations of changes in lung aeration
Measured: 6-24 hours
Secondary outcomes (1)
Staff and parent questionnaires
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start24 Nov 2023
- Primary completion25 Feb 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Middlesex University
- Responsible party
- Principal investigator, Merja Kallio, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171867
- Sponsor's protocol ID
- EETTMK: 73/2021
- Acronym
- PNEUMACRIT
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Neonate/ Neonatal Embedded Universal Microelectronic Wearable Acquisition for Cardio Respiratory Intensive Therapy. Clinical Assessment of Device Usability and Reliability
- ClinicalTrials.gov ID
- NCT06171867
- Acronym / sponsor ID
- PNEUMACRIT / EETTMK: 73/2021
- Conditions
- Neonatal Respiratory Distress
- Keywords
- Electrical impedance tomography, neonate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Middlesex University
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 25 Feb 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The usability of a new PNEUMACRIT system is studied in clinical environment in this feasibility study.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The device feasibility will be assessed in clinical environment with feedback from both the patient parents and nurses in NICU/PICU.
| Arm | Type | Receives |
|---|---|---|
| Feasibility of the PNEUMACRIT belt | Experimental | Device: PNEUMACRITNeonates will be monitored with a PNEUMACRIT electrode belt for 6 to 24 hours. After the study period, patient parents and nurses will give feedback. |
Who may qualify
- Ages
- 12 hours to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNEUMACRITMonitoring of breathing | Device | Feasibility of the PNEUMACRIT belt |
Primary outcome
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
1 secondary outcome
Staff and parent questionnaires
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNEUMACRIT in people with Neonatal Respiratory Distress, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of recording time with high quality EIT-signal (time frame: 6-24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.