CClinicalTrials.gg
Not yet recruitingNCT06229821IPVUpdated Jan 31, 2024

Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

An interventional study of Intrapulmonary Percussive Ventilation in Respiratory Distress Syndrome in Premature Infant, sponsored by Augusta University. Not yet recruiting. Open to participants aged 14 Days and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Augusta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
14 Days and older
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Distress Syndrome in Premature Infant
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Days and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

INCLUSION CRITERIA

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Other
    Intervention group

    Device: Intrapulmonary Percussive Ventilation

Interventions

  • DeviceIntrapulmonary Percussive Ventilation

    IPV applied at increasing intervals, starting every 6 hours, and ending at every 24 hours, for a total of 7 days.

06

What researchers measure

Primary outcomes

  1. Mechanical ventilation and supplemental oxygen

    Need for mechanical ventilation and supplemental oxygen administration

    Time frame: 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

    Time frame: At 36 weeks gestational age

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06229821
Lead sponsor
Augusta University
Responsible party
Michel Garcia Crespo (Principal Investigator, Augusta University) — Principal investigator
First posted
Jan 29, 2024
Start date
Mar 1, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jan 31, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion