Respiratory Distress Syndrome in Premature InfantIPVNCT06229821
Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants
A study testing Intrapulmonary Percussive Ventilation in people with Respiratory Distress Syndrome in Premature Infant, run by Augusta University.
Trial summary
The purpose of this study is to evaluate the benefits and safety of Intrapulmonary Percussive Ventilation in preterm infants. IPV has been demonstrated to be safe, and improve airway secretions clearance and decreased atelectasis in pediatric patients. We aim to evaluate the effects of IPV in preterm infants. Read more about this study
- Who is it for?
- Ages 14 days and older
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Intrapulmonary Percussive Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Dec 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 14 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Premature infants born before 32 weeks of gestation with birth weight less than 1500 grams.
- Infants requiring positive pressure ventilation by 14 days of life. EXCLUSION CRITERIA
- Infants with known or suspected chromosomal anomalies (Trisomy 13, 18, 21)
- Infants with Congenital Diaphragmatic Hernia
- Presence of air leak syndrome (pneumothorax, pneumomediastinum)
- Previous diagnosis of air leak syndrome.
Who cannot join
None listed.
About this study
The purpose of this study is to evaluate the benefits and safety of Intrapulmonary Percussive Ventilation in preterm infants. IPV has been demonstrated to be safe, and improve airway secretions clearance and decreased atelectasis in pediatric patients. We aim to evaluate the effects of IPV in preterm infants.
- Being tested
- Intrapulmonary Percussive Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrapulmonary Percussive VentilationDevice
IPV applied at increasing intervals, starting every 6 hours, and ending at every 24 hours, for a total of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Other | Not described Receives: Device: Intrapulmonary Percussive Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical ventilation and supplemental oxygen
Need for mechanical ventilation and supplemental oxygen administration
Measured: From the date of starting treatment protocol to 2 weeks after.
Secondary outcomes (1)
Diagnosis of Bronchopulmonary Dysplasia
Need for mechanical ventilation and supplemental oxygen administration
Measured: At 36 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome in Premature InfantStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Application of Intrapulmonary Percussive Ventilation (IPV) in preterm neonates, older than 14 days, who require mechanical ventilation. IPV will be administered in increasing intervals, for 15 minutes, starting every 6 hours, and ending every 24 hours; for a total of 7 days.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Garcia Crespo, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229821
- Sponsor's protocol ID
- 2067921-2
- Acronym
- IPV
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants
- ClinicalTrials.gov ID
- NCT06229821
- Acronym / sponsor ID
- IPV / 2067921-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jan 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 purpose of this study is to evaluate the benefits and safety of Intrapulmonary Percussive Ventilation in preterm infants. IPV has been demonstrated to be safe, and improve airway secretions clearance and decreased atelectasis in pediatric patients. We aim to evaluate the effects of IPV in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Application of Intrapulmonary Percussive Ventilation (IPV) in preterm neonates, older than 14 days, who require mechanical ventilation. IPV will be administered in increasing intervals, for 15 minutes, starting every 6 hours, and ending every 24 hours; for a total of 7 days.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Other | Device: Intrapulmonary Percussive Ventilation |
Who may qualify
- Ages
- 14 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Premature infants born before 32 weeks of gestation with birth weight less than 1500 grams.
- Infants requiring positive pressure ventilation by 14 days of life. EXCLUSION CRITERIA
- Infants with known or suspected chromosomal anomalies (Trisomy 13, 18, 21)
- Infants with Congenital Diaphragmatic Hernia
- Presence of air leak syndrome (pneumothorax, pneumomediastinum)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intrapulmonary Percussive VentilationIPV applied at increasing intervals, starting every 6 hours, and ending at every 24 hours, for a total of 7 days. | Device | Intervention group |
Primary outcome
Mechanical ventilation and supplemental oxygen
Time frame: From the date of starting treatment protocol to 2 weeks after.
Need for mechanical ventilation and supplemental oxygen administration
1 secondary outcome
Diagnosis of Bronchopulmonary Dysplasia
Time frame: At 36 weeks gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intrapulmonary Percussive Ventilation in people with Respiratory Distress Syndrome in Premature Infant, run by Augusta University.
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 0 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Mechanical ventilation and supplemental oxygen (time frame: From the date of starting treatment protocol to 2 weeks after.). 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 31 Jan 2024.