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Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06229821
Acronym
IPV
Enrollment
10
Registered
2024-01-29
Start date
2024-03-01
Completion date
2024-12-31
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome in Premature Infant

Brief 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.

Interventions

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

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
14 Days to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mechanical ventilation and supplemental oxygenFrom the date of starting treatment protocol to 2 weeks after.Need for mechanical ventilation and supplemental oxygen administration

Secondary

MeasureTime frameDescription
Diagnosis of Bronchopulmonary DysplasiaAt 36 weeks gestational ageNeed for mechanical ventilation and supplemental oxygen administration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026