Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress Syndrome in Premature Infant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type OTHER

Intrapulmonary Percussive Ventilation

Intervention Type DEVICE

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

Interventions

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Intrapulmonary Percussive Ventilation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No