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Outcome Measures

Primary Outcomes (1)

Alive ventilator free days
The number of days alive and ventilator-free
Days 1-28 after birth

Secondary Outcomes (17)

Alive at day 28 after birth
Day 28 after birth
Ventilator free
Day 28 after birth
Bronchopulmonary dysplasia
Measured at 36 weeks' postmenstrual age
Bronchopulmonary dysplasia
Measured at 36 weeks' postmenstrual age
Air leak syndrome
Day 1-28 after birth
+12 more secondary outcomes

Study Arms (2)

Mid frequency ventilation

OTHER

Mid frequency ventilation delivered at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.

Device: Mid frequency ventilation

Standard frequency ventilation

OTHER

Standard frequency ventilation delivered at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Device: Standard frequency ventilation

Interventions

Mid frequency ventilationDevice

Mechanical ventilator used at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.

Mid frequency ventilation

Standard frequency ventilationDevice

Mechanical ventilator used at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Standard frequency ventilation

Eligibility Criteria

Age1 Day - 3 Days

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Infants ≥ 23+0/7 weeks and ≤ 36+6/7 who are intubated and mechanically ventilated for respiratory distress syndrome (defined by use of surfactant) within 48 hours after birth
Infants whose parents/legal guardians have provided consent for enrollment

MeSH Terms

Conditions

Ventilator-Induced Lung InjuryRespiratory Distress SyndromeBronchopulmonary DysplasiaPremature Birth

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy Complications

Study Design

Study Type

interventional

Phase

phase 2 3

Allocation

RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: This will be a randomized controlled trial with a 1:1 parallel allocation of infants to mid or standard frequency ventilation using stratified permuted block design.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Principal Investigator

Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Study Arms (2)

Mid frequency ventilation

Standard frequency ventilation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (17)

Study Arms (2)

Mid frequency ventilation

Standard frequency ventilation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations