Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

NCT03231735 | Completed Phase 2 DMC

• 1 other identifier: F160701002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine, in preterm infants less than 37 weeks gestation with respiratory distress who are ventilated in the first 48 hours after birth, if mid frequency ventilation strategy using ventilator rate of ≥ 60 to ≤ 150 per minute compared with standard frequency ventilation strategy using ventilator rates of ≥ 20 to \< 60 per minute will increase the number of alive ventilator-free days after randomization and reduce the risk of ventilator induced lung injury.

Conditions

Ventilator-Induced Lung Injury; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Preterm Infant

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

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 ventilation DEVICE

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

Mid frequency ventilation

Standard frequency ventilation DEVICE

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

Standard frequency ventilation

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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
• Inborn or outborn infants transferred to this center before 48 hours after birth
• Ventilator rate ≤ 80 per minute prior to enrollment

You may not qualify if:

• a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of South Alabama: collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of South Alabama

Mobile, Alabama, 36604, United States

Location

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Waldemar A Carlo, MD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: July 27, 2017
• Study Start: August 2, 2017
• Primary Completion: November 21, 2021
• Study Completion: October 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)