Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

NCT06229821 | Unknown DMC

• 1 other identifier: 2067921-2
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Distress Syndrome in Premature Infant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnosis of Bronchopulmonary Dysplasia

  At 36 weeks gestational age

Study Arms (1)

Intervention group

OTHER

Device: Intrapulmonary Percussive Ventilation

Interventions

Intrapulmonary Percussive Ventilation DEVICE

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

Intervention group

Eligibility Criteria

• Age: 14 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Premature infants born before 32 weeks of gestation with birth weight less than 1500 grams.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 29, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01