Apnea of NewbornRESPSUSNCT04584814
Analyze Changes in Respiratory Rate When Using the Scare Respirator
A study testing without any device, scare ventilator at 20 and scare ventilator at 40 in people with Apnea of Newborn and Preterm Labor, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare ventilator" Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Apnea of Newborn, Preterm Labor
- What is being tested?
- without any device, scare ventilator at 20 and scare ventilator at 40
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2020to 1 Mar 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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- hospitalized healthy preterm babies,
Who cannot join
- babies receiving mechanical ventilation
- carrier of any mayor malformation or genetic condition
- sick or having an thorax or abdomen surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Using the Scare Respirator: Effect on Synchronicity, Respiratory Rate, Heart Rate, Oxygen Saturation, Neonatal-Infant Pain Scale (NIPS) and Sleep-wake Cycle on Amplitude Electroencephalography( aEEG)
Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare ventilator"
Read the detailed description
With this pilot study the investigator's want to see if the "scare respirator" can modify the vital signs of the newborn (NB) and if there is a relationship according to the frequency per minute given by the scare respirator and the patient's respiratory rate.
The "scare respirator" has been used many times to prevent central apnea in the newborn. This involves using a mechanical ventilator, but instead of connecting it to the patient's trachea to inflate his lungs, the air flow is connected to a surgical glove that inflates and deflates, with the optimal respiratory rate that the patient should have. This will be placed on the back to stimulate it tactically giving the necessary impulse of inspiration so that the patient alone can acquire the movement.
The importance of the development of this study is that it has been seen that the "scare respirator" could avoid central apneas, but no studies have been done on the change in respiratory rate that occurs with the device or if it bothers the NB or alters its wakefulness sleep pattern.
It is intended to evaluate 10 premature infants, during 3 observation periods. Heart rate (HR), Respiratory rate (RR) and saturation, pain scale and aEEG sleep wake pattern will be evaluated; first a rest period between feeds as baseline, then with a scare respirator at 20 cycles per minute and finally at 40 cycles per minute. The differences of qualitative and quantitative variables will be assessed with ad-hoc statistical tests.
- Conditions
- Apnea of Newborn, Preterm Labor
- Being tested
- without any device, scare ventilator at 20, scare ventilator at 40
- Keywords
- respiratory rate, scare ventilator, sleep wake cycle
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without any deviceDevice
Basal analysis
scare ventilator at 20Device
To set scare ventilator by 20 cycles per minute
scare ventilator at 40Device
To set scare ventilator by 40 cycles per minute
| Study group | Role | What they receive |
|---|---|---|
| Prematures basal | Sham comparator | Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings basal, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes Receives: Device: without any device |
| 20 x min pulsatil stimuli | Active comparator | Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings, with 20xmin min dorsal pulsatil stimuly, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes Receives: Device: scare ventilator at 20 |
| 20x min pulsatil stimuli | Active comparator | Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings, basal, with 20xmin and 40x min dorsal pulsatil stimuly, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes Receives: Device: scare ventilator at 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm)
% of time were respiratory rate is synchronised with the scare ventilator input, two tales of statistical differences, at 20 and 40 cycles per minute (cpm)
Measured: 2 hours interfedings at the study day
Secondary outcomes (11)
Change from baseline newborn HR using the scare ventilator at 20 cpm
differences in HR mean with two tales of statistical analysis ,between the two study periods
Measured: 2 hours interfedings at the study day
Change from baseline newborn HR using the scare ventilator at 40 cpm
differences in HR mean with two tales of statistical analysis ,between the two study periods
Measured: 2 hours interfedings at the study day
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
Measured: 2 hours interfedings at the study day
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm
% of time of aEEG SWC presence, two tales of statistical differences, between the 2 study periods
Measured: 2 hours interfedings at the study day
Change from baseline on Discomfort scale using the scare ventilator at 20 cpm
Differences with the NIPS average, two tales of statistical differences, between the two study periods (scale 0-10; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain)
Measured: 2 hours interfedings at the study day
Change from baseline on Discomfort scale using the scare ventilator at 40 cpm
Differences with the NIPS average, two tales of statistical differences, between the two study periods (scale 0-10; 0-2 no pain, 3-4 moderate pain, 5 or more severe pain)
Measured: 2 hours interfedings at the study day
Change from baseline on RR using the scare ventilator at 20 cpm
differences in RR mean with two tales of statistical differences between the two periods
Measured: 2 hours interfedings at the study day
Change from baseline on RR using the scare ventilator at 40 cpm
differences in RR mean with two tales of statistical differences between the two periods
Measured: 2 hours interfedings at the study day
Change from baseline on oxygen saturation using the scare ventilator at 20 cpm
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods
Measured: 2 hours interfedings at the study day
Change from baseline on oxygen saturation using the scare ventilator at 40 cpm
differences in mean oxygen saturation expressed as a % , with two tales of statistical differences between the two periods
Measured: 2 hours interfedings at the study day
Adverse events
Register and look active for adverse events during interventions
Measured: From enrollment to the end of the hospitalization time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Mar 2020
- Primary completion31 Oct 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of 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
- Randomised
- Intervention model
- Crossover
- Model description
- 10 preterms are going to be put on random measures in 2 hours blocks of, no intervention 2 hours of scare ventilator settled at 20 cycles per minute, and 2 hours of scare ventilator at 40cycles per minute
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulina Toso, Pontificia Universidad Catolica de Chile
- Investigators
- Paulina Toso, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584814
- Sponsor's protocol ID
- 180926007
- Acronym
- RESPSUS
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Using the Scare Respirator: Effect on Synchronicity, Respiratory Rate, Heart Rate, Oxygen Saturation, Neonatal-Infant Pain Scale (NIPS) and Sleep-wake Cycle on Amplitude Electroencephalography( aEEG)
- ClinicalTrials.gov ID
- NCT04584814
- Acronym / sponsor ID
- RESPSUS / 180926007
- Conditions
- Apnea of Newborn, Preterm Labor
- Keywords
- respiratory rate, scare ventilator, sleep wake cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 Oct 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.
Pilot study of 10 preterm, who are going to be randomly placed to 3 phases : 2 hour of basal observation of respiratory rate, heart rate, saturation, NIPS and aEEG recording, 2 hours with a 20cycles/minute with "scare ventilator", and 2 hours of 40 cycles/minute with "scare ventilator"
Detailed description
With this pilot study the investigator's want to see if the "scare respirator" can modify the vital signs of the newborn (NB) and if there is a relationship according to the frequency per minute given by the scare respirator and the patient's respiratory rate.
The "scare respirator" has been used many times to prevent central apnea in the newborn. This involves using a mechanical ventilator, but instead of connecting it to the patient's trachea to inflate his lungs, the air flow is connected to a surgical glove that inflates and deflates, with the optimal respiratory rate that the patient should have. This will be placed on the back to stimulate it tactically giving the necessary impulse of inspiration so that the patient alone can acquire the movement.
The importance of the development of this study is that it has been seen that the "scare respirator" could avoid central apneas, but no studies have been done on the change in respiratory rate that occurs with the device or if it bothers the NB or alters its wakefulness sleep pattern.
It is intended to evaluate 10 premature infants, during 3 observation periods. Heart rate (HR), Respiratory rate (RR) and saturation, pain scale and aEEG sleep wake pattern will be evaluated; first a rest period between feeds as baseline, then with a scare respirator at 20 cycles per minute and finally at 40 cycles per minute. The differences of qualitative and quantitative variables will be assessed with ad-hoc statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 10 preterms are going to be put on random measures in 2 hours blocks of, no intervention 2 hours of scare ventilator settled at 20 cycles per minute, and 2 hours of scare ventilator at 40cycles per minute
| Arm | Type | Receives |
|---|---|---|
| Prematures basal | Sham comparator | Device: without any devicePreterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings basal, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes |
| 20 x min pulsatil stimuli | Active comparator | Device: scare ventilator at 20Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings, with 20xmin min dorsal pulsatil stimuly, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes |
| 20x min pulsatil stimuli | Active comparator | Device: scare ventilator at 40Preterm babies <34 w of GA, without MV support and any chronic or acute illness, were evaluated during 2-h periods interfeedings, basal, with 20xmin and 40x min dorsal pulsatil stimuly, and analized RR, HR, SpO2, NIPS, aEEG + respiratory synchronicity during 2-h between feedings every 10 minutes |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- hospitalized healthy preterm babies,
Key exclusion criteria (3 listed)
- babies receiving mechanical ventilation
- carrier of any mayor malformation or genetic condition
- sick or having an thorax or abdomen surgery
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 |
|---|---|---|
| without any deviceBasal analysis | Device | Prematures basal |
| scare ventilator at 20To set scare ventilator by 20 cycles per minute | Device | 20 x min pulsatil stimuli |
| scare ventilator at 40To set scare ventilator by 40 cycles per minute | Device | 20x min pulsatil stimuli |
Primary outcome
Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm)
Time frame: 2 hours interfedings at the study day
% of time were respiratory rate is synchronised with the scare ventilator input, two tales of statistical differences, at 20 and 40 cycles per minute (cpm)
11 secondary outcomes
Change from baseline newborn HR using the scare ventilator at 20 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline newborn HR using the scare ventilator at 40 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 20 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on Sleep-wake cycles (SWC) using the scare ventilator at 40 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on Discomfort scale using the scare ventilator at 20 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on Discomfort scale using the scare ventilator at 40 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on RR using the scare ventilator at 20 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on RR using the scare ventilator at 40 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on oxygen saturation using the scare ventilator at 20 cpm
Time frame: 2 hours interfedings at the study day
Change from baseline on oxygen saturation using the scare ventilator at 40 cpm
Time frame: 2 hours interfedings at the study day
Adverse events
Time frame: From enrollment to the end of the hospitalization time
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 26 Aug 2026.
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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.
Paulina Toso, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing without any device, scare ventilator at 20 and scare ventilator at 40 in people with Apnea of Newborn and Preterm Labor, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 1 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 26 Aug 2026. 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 Chile. 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. Some participants in this study may receive a placebo. 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?
Change of respiratory Synchronicity with the scare ventilator between 20 and 40 cycles per minute (cpm) (time frame: 2 hours interfedings at the study day). 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 26 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.