Premature InfantsNCT04659083
How NAVA Works in Preterm Infants With Irregular Respiratory Efforts
An observational study of Premature Infants and Neurally Adjusted Ventilatory Assist, run by Inha University Hospital at 1 site in Finland.
Trial summary
For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Read more about this study
- Who is it for?
- Ages 0 days to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature Infants, Neurally Adjusted Ventilatory Assist, Ventilator Lung; Newborn
- What is being tested?
- Neurally adjusted ventilatory assist ventilation mode
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- 1 Mar 2020to 31 Dec 2020
- Phase
- Observational
- 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 0 days to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: We included preterm infants born before 36 weeks of gestation who received at least 24 hours of ventilatory support with invasive or non-invasive NAVA using a Servo-i or Servo-n ventilator (Getinge, Gothenburg, Sweden).
Who may be able to join
- babies who receiving respiratory support with neurally adjusted ventilatory assist
- babies with informed consents from their parents
Who cannot join
- babies using anesthetic agents
Trial locations and contacts
1 site in 1 country.
About this study
For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period.
The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.
- Conditions
- Premature Infants, Neurally Adjusted Ventilatory Assist, Ventilator Lung; Newborn, Mechanical Ventilation
- Being tested
- Neurally adjusted ventilatory assist ventilation mode
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally adjusted ventilatory assist ventilation modeDevice
This technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of backup breaths by the ventilator
% time of backup/min according to babies' weight, postmenstrual age and postnatal age
Measured: during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital
- Responsible party
- Principal investigator, Juyoung Lee, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659083
- Sponsor's protocol ID
- NAVA-Turku01
- Status last verified
- Jan 2021
- First submitted
- 2 Dec 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee J, Parikka V, Lehtonen L, Soukka H. Backup ventilation during neurally adjusted ventilatory assist in preterm infants. Pediatr Pulmonol. 2021 Oct;56(10):3342-3348. doi: 10.1002/ppul.25583. Epub 2021 Jul 26.
PubMed 34310871
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How NAVA Works in Preterm Infants With Irregular Respiratory Efforts
- ClinicalTrials.gov ID
- NCT04659083
- Acronym / sponsor ID
- NAVA-Turku01
- Conditions
- Premature Infants, Neurally Adjusted Ventilatory Assist, Ventilator Lung; Newborn, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Dec 2020 (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.
For the infant participating the study, ventilator settings and respiratory variables will be recorded every day and exported to a specific computer using the Servo Record Viewer version 1.0 (Maquet Critical Care AB, Getinge, Gothenburg, Sweden). Collected data gives the value for peak inspiratory pressure (PIP), expiratory tidal volume (Vt), peak Edi, minimum Edi, measured respiratory rate (RR), neural respiratory rate (nRR) and percentage of backup breaths for each minute. All the ventilator data will be inspected and compared with the event logs recorded automatically from the ventilator, which includes all the alarm notification, mode and setting changes, cables connection and disconnection data. Data during disconnection of the Edi cable, malfunction or dislocation of Edi catheter will be excluded from the analysis. The mean values during each day will be computed for each ventilatory variables. If there is a change in the ventilatory setting parameters, we will choose the one which was applied for longer duration in the 24-hour time period.
The following clinical characteristics will be collected from medical records: gestational age at birth, birth weight, gender, the time and amount of feeding, medication during the study days, desaturation events, bradycardia events, suction time and methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 days to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- We included preterm infants born before 36 weeks of gestation who received at least 24 hours of ventilatory support with invasive or non-invasive NAVA using a Servo-i or Servo-n ventilator (Getinge, Gothenburg, Sweden).
Key inclusion criteria (2 listed)
- babies who receiving respiratory support with neurally adjusted ventilatory assist
- babies with informed consents from their parents
Key exclusion criteria (1 listed)
- babies using anesthetic agents
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 |
|---|---|---|
| Neurally adjusted ventilatory assist ventilation modeThis technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure. | Device | – |
Primary outcome
the amount of backup breaths by the ventilator
Time frame: during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age
% time of backup/min according to babies' weight, postmenstrual age and postnatal age
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 12 Jan 2021.
- Derived from this study: PubMed 34310871Lee J, Parikka V, Lehtonen L, Soukka H. Backup ventilation during neurally adjusted ventilatory assist in preterm infants. Pediatr Pulmonol. 2021 Oct;56(10):3342-3348. doi: 10.1002/ppul.25583. Epub 2021 Jul 26.
- Individual participant dataSharing planned: No
Related trials for Premature Infants
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
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?
An observational study of Premature Infants and Neurally Adjusted Ventilatory Assist, run by Inha University Hospital 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 2 inclusion and 1 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 12 Jan 2021. 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?
the amount of backup breaths by the ventilator (time frame: during the respiratory support using NAVA, from day 1 until the end of 36 weeks of postmenstrual age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659083, which also lists 1 linked publication.
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 12 Jan 2021.