Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants (IPV)

Augusta University

Status: Not yet enrolling

Conditions: Respiratory Distress Syndrome in Premature Infant

Treatments: Device: Intrapulmonary Percussive Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06229821

2067921-2

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 14+ days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention group

Other group

Treatment:

Device: Intrapulmonary Percussive Ventilation