Apnea of PrematurityNCT06639581
Pilot Study to Evaluate Doses of Mechanical Stimulus on the Effectiveness of Preterm Breathing
A study testing 20 per minute stimulus, 30 per minute stimulus and 40 per minute stimulus in people with Apnea of Prematurity and Intermittent Hypoxia, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The goal of this clinical trial is to compare, in healthy preterm babies, 9 doses of dorsal mechanical stimuli, in order to answer: if there is a dose of dorsal mechanical stimuli that improves the basal respiration. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Apnea of Prematurity, Intermittent Hypoxia
- What is being tested?
- 20 per minute stimulus, 30 per minute stimulus and 40 per minute stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChile
- Study dates
- 10 Oct 2022to 31 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: 24-34 weeks of birth gestational age (BGA) preterms, healthy -
Exclusion Criteria: respiratory support, thoracic or abdominal malformations-recent surgeries, hypotonic syndromes
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 9 Doses of Dorsal Mechanical Stimulus on Volume Respiratory Measures on Healthy Preterms: a Pilot Study
The goal of this clinical trial is to compare, in healthy preterm babies, 9 doses of dorsal mechanical stimuli, in order to answer:
- if there is a dose of dorsal mechanical stimuli that improves the basal respiration.
Participants will be stimulated through a cotton shirt for one minute with each dose, while respiratory measures will be taken through a nasobuccal mask, slightly tightened by the investigator staff. All time, babies are going to be monitored and assessing that they are comfortable.
Read the detailed description
Apnea of Prematurity (AOP) occurs in 90% of infants born at ≤34 weeks of gestation. Despite current treatments, these infants continue to experience intermittent hypoxia (IH) events, which lead to subsequent complications. Dorsal and extremity kinesthetic stimulation-commonly practiced in patients experiencing apnea-has been shown to trigger the infant's own respiratory effort. Several clinical studies have demonstrated that mechanized or reactive stimulation, performed with various devices and at different intensities, decreases the number of apneas and reduces the time spent with oxygen saturation levels below 90%, a measure of IH. However, there are also reports of no favorable effects with certain other stimulation mechanisms.
To study the kinesthetic mechanism, a pilot study was conducted on 10 healthy premature infants. The infants were dorsally stimulated using a surgical glove inflated by a mechanical ventilator at rates of 20 and 40 cycles per minute, applying a standardized stimulus independent of weight and gestational age. The main results showed that, during the stimulation period, the respiratory rate decreased by 19-50% compared to baseline (without stimulation), while oxygen saturation increased by 2-7 percentage points. Additionally, it was observed that synchronization of breathing with the dorsal stimulus occurred 0-77% of the time.
These observations could be explained by the assumption that premature infants achieved more effective breaths through stimulation, recruiting more alveolar units, and potentially triggering the Hering-Breuer reflex, which inhibits subsequent respiratory efforts. Although these findings were statistically significant based on the analysis of paired sample means, not all infants responded in the same way.
Method: A pilot study involving 10 healthy preterm infants (24-34 weeks gestational age) will be conducted. The infants will be stimulated on their backs with different combinations of lifting (3, 5, and 8 mm) and frequency (20, 30, and 40 cycles per minute) using a shirt equipped with an inflating-deflating actuator. The main outcome will be a comparison of minute ventilation and tidal volumes at baseline and with the different stimulation doses. The software "Rec Trial" will be used to record vital signs, operational settings, respiratory volumes, and patterns for repeated measures ANOVA analysis. The expected results are to find the optimal combination of lifting and frequency stimulus to optimize minute ventilation and/or detect relevant respiratory patterns that improve minute ventilation.
- Conditions
- Apnea of Prematurity, Intermittent Hypoxia
- Being tested
- 20 per minute stimulus, 30 per minute stimulus, 40 per minute stimulus
- Keywords
- preterm, hypoxia, medical device
- Medical subject headings
- Apnea, Premature Birth, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20 per minute stimulusDevice
crossover randomized mechanical dorsal stimuli -for one minute each- at 20-rates per minute
30 per minute stimulusDevice
crossover randomized mechanical dorsal stimuli -for one minute each- at 30 rates per minute
40 per minute stimulusDevice
crossover randomized mechanical dorsal stimuli -for one minute each- at 40 rates per minute
| Study group | Role | What they receive |
|---|---|---|
| 3mm lifting stimulus | Active comparator | Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 3 mm , performed by 2 operators . Receives: Device: 20 per minute stimulus; Device: 30 per minute stimulus; Device: 40 per minute stimulus |
| 5mm lifting stimulus | Active comparator | Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 5 mm , performed by 2 operators . Receives: Device: 20 per minute stimulus; Device: 30 per minute stimulus; Device: 40 per minute stimulus |
| 8mm lifting stimulus | Active comparator | Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 8 mm , performed by 2 operators . Receives: Device: 20 per minute stimulus; Device: 30 per minute stimulus; Device: 40 per minute stimulus |
| Basal | No intervention | Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm basal- without stimulation- performed by 2 operators . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean of Tidal Volume(TV) between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean of Tidal Volume ( ml/kg)
Measured: 1 minute for each intervention ( dose)
Comparison of mean of Minute Ventilation (MV) between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean of MV ( ml/kg/ min)
Measured: 1 minute for each intervention ( dose)
Secondary outcomes (3)
Comparison of mean of Respiratory Rate (RR)between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean RR (rpm)
Measured: 1 minute for each intervention ( dose)
Comparison of mean of Cardiac Rate (CR)between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean CR (rpm)
Measured: 1 minute for each intervention ( dose)
Comparison of mean of percent of oxygen saturation (Sats) between the doses of dorsal mechanical stimuli
repeated measures ANOVA for mean Sats (percent)
Measured: 1 minute for each intervention ( dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Oct 2022
- Primary completion31 Mar 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A baseline evaluation will be carried out and with the 9 doses of dorsal stimulation resulting from the combination of displacements of 3-5 -8 mm and 20-30-40 cycles per minute, randomized and performed by 2 operators each.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 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 A Toso, MD, Study director, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639581
- Sponsor's protocol ID
- 210406008
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 9 Doses of Dorsal Mechanical Stimulus on Volume Respiratory Measures on Healthy Preterms: a Pilot Study
- ClinicalTrials.gov ID
- NCT06639581
- Acronym / sponsor ID
- 210406008
- Conditions
- Apnea of Prematurity, Intermittent Hypoxia
- Keywords
- preterm, hypoxia, medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 15 Oct 2024 (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 goal of this clinical trial is to compare, in healthy preterm babies, 9 doses of dorsal mechanical stimuli, in order to answer:
- if there is a dose of dorsal mechanical stimuli that improves the basal respiration.
Participants will be stimulated through a cotton shirt for one minute with each dose, while respiratory measures will be taken through a nasobuccal mask, slightly tightened by the investigator staff. All time, babies are going to be monitored and assessing that they are comfortable.
Detailed description
Apnea of Prematurity (AOP) occurs in 90% of infants born at ≤34 weeks of gestation. Despite current treatments, these infants continue to experience intermittent hypoxia (IH) events, which lead to subsequent complications. Dorsal and extremity kinesthetic stimulation-commonly practiced in patients experiencing apnea-has been shown to trigger the infant's own respiratory effort. Several clinical studies have demonstrated that mechanized or reactive stimulation, performed with various devices and at different intensities, decreases the number of apneas and reduces the time spent with oxygen saturation levels below 90%, a measure of IH. However, there are also reports of no favorable effects with certain other stimulation mechanisms.
To study the kinesthetic mechanism, a pilot study was conducted on 10 healthy premature infants. The infants were dorsally stimulated using a surgical glove inflated by a mechanical ventilator at rates of 20 and 40 cycles per minute, applying a standardized stimulus independent of weight and gestational age. The main results showed that, during the stimulation period, the respiratory rate decreased by 19-50% compared to baseline (without stimulation), while oxygen saturation increased by 2-7 percentage points. Additionally, it was observed that synchronization of breathing with the dorsal stimulus occurred 0-77% of the time.
These observations could be explained by the assumption that premature infants achieved more effective breaths through stimulation, recruiting more alveolar units, and potentially triggering the Hering-Breuer reflex, which inhibits subsequent respiratory efforts. Although these findings were statistically significant based on the analysis of paired sample means, not all infants responded in the same way.
Method: A pilot study involving 10 healthy preterm infants (24-34 weeks gestational age) will be conducted. The infants will be stimulated on their backs with different combinations of lifting (3, 5, and 8 mm) and frequency (20, 30, and 40 cycles per minute) using a shirt equipped with an inflating-deflating actuator. The main outcome will be a comparison of minute ventilation and tidal volumes at baseline and with the different stimulation doses. The software "Rec Trial" will be used to record vital signs, operational settings, respiratory volumes, and patterns for repeated measures ANOVA analysis. The expected results are to find the optimal combination of lifting and frequency stimulus to optimize minute ventilation and/or detect relevant respiratory patterns that improve minute ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A baseline evaluation will be carried out and with the 9 doses of dorsal stimulation resulting from the combination of displacements of 3-5 -8 mm and 20-30-40 cycles per minute, randomized and performed by 2 operators each.
| Arm | Type | Receives |
|---|---|---|
| 3mm lifting stimulus | Active comparator | Device: 20 per minute stimulus, Device: 30 per minute stimulus, Device: 40 per minute stimulusRespiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 3 mm , performed by 2 operators . |
| 5mm lifting stimulus | Active comparator | Device: 20 per minute stimulus, Device: 30 per minute stimulus, Device: 40 per minute stimulusRespiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 5 mm , performed by 2 operators . |
| 8mm lifting stimulus | Active comparator | Device: 20 per minute stimulus, Device: 30 per minute stimulus, Device: 40 per minute stimulusRespiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm, by dorsal stimulation causing a displacement of 8 mm , performed by 2 operators . |
| Basal | No intervention | –Respiratory volume measures, vital signs and respiratory mechanics will be evaluated in 10 healthy preterm basal- without stimulation- performed by 2 operators . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| 20 per minute stimuluscrossover randomized mechanical dorsal stimuli -for one minute each- at 20-rates per minute | Device | 3mm lifting stimulus, 5mm lifting stimulus, 8mm lifting stimulus |
| 30 per minute stimuluscrossover randomized mechanical dorsal stimuli -for one minute each- at 30 rates per minute | Device | 3mm lifting stimulus, 5mm lifting stimulus, 8mm lifting stimulus |
| 40 per minute stimuluscrossover randomized mechanical dorsal stimuli -for one minute each- at 40 rates per minute | Device | 3mm lifting stimulus, 5mm lifting stimulus, 8mm lifting stimulus |
Primary outcome
Comparison of mean of Tidal Volume(TV) between the doses of dorsal mechanical stimuli
Time frame: 1 minute for each intervention ( dose)
repeated measures ANOVA for mean of Tidal Volume ( ml/kg)
Comparison of mean of Minute Ventilation (MV) between the doses of dorsal mechanical stimuli
Time frame: 1 minute for each intervention ( dose)
repeated measures ANOVA for mean of MV ( ml/kg/ min)
3 secondary outcomes
Comparison of mean of Respiratory Rate (RR)between the doses of dorsal mechanical stimuli
Time frame: 1 minute for each intervention ( dose)
Comparison of mean of Cardiac Rate (CR)between the doses of dorsal mechanical stimuli
Time frame: 1 minute for each intervention ( dose)
Comparison of mean of percent of oxygen saturation (Sats) between the doses of dorsal mechanical stimuli
Time frame: 1 minute for each intervention ( dose)
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 15 Oct 2024.
- Individual participant dataSharing planned: No
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Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
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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 A Toso, MD study director
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 20 per minute stimulus, 30 per minute stimulus and 40 per minute stimulus in people with Apnea of Prematurity and Intermittent Hypoxia, 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 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 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. 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?
Comparison of mean of Tidal Volume(TV) between the doses of dorsal mechanical stimuli (time frame: 1 minute for each intervention ( dose)). The study lists 2 primary outcomes in all. 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 15 Oct 2024.