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NCT06229821 Clinical Trial

Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

Respiratory Distress Syndrome in Premature Infant Clinical Trial

— IPV  

Official title:
Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06229821
Other study ID # 2067921-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date December 31, 2024

Study information
Verified date January 2024
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 14 Days and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intrapulmonary Percussive Ventilation
IPV applied at increasing intervals, starting every 6 hours, and ending at every 24 hours, for a total of 7 days.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Augusta University

Outcome
Type Measure Description Time frame Safety issue
Primary Mechanical ventilation and supplemental oxygen Need for mechanical ventilation and supplemental oxygen administration From the date of starting treatment protocol to 2 weeks after.
Secondary Diagnosis of Bronchopulmonary Dysplasia Need for mechanical ventilation and supplemental oxygen administration At 36 weeks gestational age
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