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

January 30, 2024 updated by: Michel Garcia Crespo, Augusta University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation and supplemental oxygen
Time Frame: From the date of starting treatment protocol to 2 weeks after.
Need for mechanical ventilation and supplemental oxygen administration
From the date of starting treatment protocol to 2 weeks after.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of Bronchopulmonary Dysplasia
Time Frame: At 36 weeks gestational age
Need for mechanical ventilation and supplemental oxygen administration
At 36 weeks gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2067921-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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