Ventilator Lung; NewbornNCT04836689
Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
A study testing nasal intermittent positive pressure ventilation (NIPPV). in people with Ventilator Lung; Newborn, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Ventilator Lung; Newborn
- What is being tested?
- nasal intermittent positive pressure ventilation (NIPPV).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2021to 1 Sep 2022
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 240 to 336.
- At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm).
- At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
- At least 6 hours from surfactant administration.
- Parental consent
Who cannot join
- If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is<40mmHg.
- If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is>60mmHg.
- Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
Trial locations and contacts
1 site in 1 country.
About this study
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
Read the detailed description
This will be a prospective, crossover observational study that will be performed at Rambam NICU.
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition.
NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
- Conditions
- Ventilator Lung; Newborn
- Being tested
- nasal intermittent positive pressure ventilation (NIPPV).
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal intermittent positive pressure ventilation (NIPPV).Device
NIPPV will be administered using Leoni (Heinen\&Löwenstein, Bad Ems, Germany) and RAM cannula (Neotech, Valencia, CA).
After initial setting and before routine blood gas testing, tcCO2 will be connected and calibrated. We will use SenTec digital monitor (SenTec AG, Therwil, Switzerland). Correlation/agreement between the tcCO2 and PCO2 will be assessed and documented in each infant.
For Each infant we will get 2 set of data: Change in measurements when changing from 30 bpm to 10 bpm, and change in measurements when changing from 10 bpm to 30 bpm At the end of each hour, before rate change, we will document the following measurements:TcCO2, FiO2, saturation, the infant's respiratory rate (as measured in the monitor), number of apneas, bradycardia (heart rate<100 bpm), saturation<90% and>94% episodes (as measured in the monitor), 1-hour saturation histogram clasification.
| Study group | Role | What they receive |
|---|---|---|
| 30 breaths per minutes | Other | Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2 Receives: Device: nasal intermittent positive pressure ventilation (NIPPV). |
| 10 breaths per minute | Other | Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2 Receives: Device: nasal intermittent positive pressure ventilation (NIPPV). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trans cutaneous CO2 (TCCO2)
Trans cutaneous CO2
Measured: During the 3 hours of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Aug 2022
- Study completion1 Sep 2022
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 Ventilator Lung; NewbornStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Hochwald , MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836689
- Sponsor's protocol ID
- RMB-0490-20
- Status last verified
- Sep 2022
- First submitted
- 6 Apr 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hochwald O, Borenstein-Levin L, Dinur G, Jubran H, Littner Y, Breuer M, Kugelman A. The effect of changing respiratory rate settings on CO2 levels during nasal intermittent positive pressure ventilation (NIPPV) in premature infants. J Perinatol. 2023 Mar;43(3):305-310. doi: 10.1038/s41372-023-01614-7. Epub 2023 Feb 9.
PubMed 36759706
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV).
- ClinicalTrials.gov ID
- NCT04836689
- Acronym / sponsor ID
- RMB-0490-20
- Conditions
- Ventilator Lung; Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 8 Apr 2021 (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.
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
Detailed description
This will be a prospective, crossover observational study that will be performed at Rambam NICU.
Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition.
NIPPV rate will start high/low, changed to low/high and switched back to starting rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants will be monitored by TcCO2 during three consecutive time periods of one hour each on a high and low rate of NIPPV, when in a stable condition. NIPPV rate will start high/low, changed to low/high and switched back to starting rate
| Arm | Type | Receives |
|---|---|---|
| 30 breaths per minutes | Other | Device: nasal intermittent positive pressure ventilation (NIPPV).Using NIPPV with rate of 30 for 1 hour. Measuring trans cutaneous CO2 |
| 10 breaths per minute | Other | Device: nasal intermittent positive pressure ventilation (NIPPV).Using NIPPV with rate of 10 for 1 hour. Measuring trans cutaneous CO2 |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age 240 to 336.
- At least 6 hours of stabilized NIPPV settings, i.e. minor changes in settings (FiO2 ≤0.10, PIP≤ 2.0 cmH2O, RR≤ 5 brm).
- At least 6 hours of stabilized tcCO2, i.e. ≤5 mmHg variation.
- At least 6 hours from surfactant administration.
- Parental consent
Key exclusion criteria (3 listed)
- If NIPPV set rate is 10 bpm and tcCO2 related pCO2 is<40mmHg.
- If NIPPV set rate is 30 bpm and tcCO2 related pCO2 is>60mmHg.
- Unstable infants due to acute conditions (sepsis. IVH), or congenital malformations.
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 |
|---|---|---|
| nasal intermittent positive pressure ventilation (NIPPV).NIPPV will be administered using Leoni (Heinen\&Löwenstein, Bad Ems, Germany) and RAM cannula (Neotech, Valencia, CA). After initial setting and before routine blood gas testing, tcCO2 will be connected and calibrated. We will use SenTec digital monitor (SenTec AG, Therwil, Switzerland). Correlation/agreement between the tcCO2 and PCO2 will be assessed and documented in each infant. For Each infant we will get 2 set of data: Change in measurements when changing from 30 bpm to 10 bpm, and change in measurements when changing from 10 bpm to 30 bpm At the end of each hour, before rate change, we will document the following measurements:TcCO2, FiO2, saturation, the infant's respiratory rate (as measured in the monitor), number of apneas, bradycardia (heart rate<100 bpm), saturation<90% and>94% episodes (as measured in the monitor), 1-hour saturation histogram clasification. | Device | 10 breaths per minute, 30 breaths per minutes |
Primary outcome
Trans cutaneous CO2 (TCCO2)
Time frame: During the 3 hours of the study
Trans cutaneous CO2
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 22 Sep 2022.
- Derived from this study: PubMed 36759706Hochwald O, Borenstein-Levin L, Dinur G, Jubran H, Littner Y, Breuer M, Kugelman A. The effect of changing respiratory rate settings on CO2 levels during nasal intermittent positive pressure ventilation (NIPPV) in premature infants. J Perinatol. 2023 Mar;43(3):305-310. doi: 10.1038/s41372-023-01614-7. Epub 2023 Feb 9.
- Individual participant dataSharing planned: Undecided
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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 nasal intermittent positive pressure ventilation (NIPPV). in people with Ventilator Lung; Newborn, run by Rambam Health Care Campus at 1 site in Israel.
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 5 inclusion and 3 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 22 Sep 2022. 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 Israel. 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?
Trans cutaneous CO2 (TCCO2) (time frame: During the 3 hours of the study). 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 NCT04836689, 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 22 Sep 2022.