Safety and Efficacy of Intrapulmonary Percussive Ventilat... | NCT06229821

Studies
Safety and Efficacy of Intrapulmonary Percussive Ventilation in Preterm Infants

NCT06229821

Sponsor

Augusta University

Status

Unknown status

Last Update Posted

Jan 31, 2024Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Respiratory Distress Syndrome in Premature Infant

Interventions

Intrapulmonary Percussive Ventilation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jan 16, 2024

First Submission Date that Met QC Criteria

Jan 26, 2024

First Posted Date

Jan 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2024

Last Update Posted Date

Jan 31, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Other		Device: Intrapulmonary Percussive Ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Model Description

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.