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Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

NCT03231735 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-15

No results posted yet for this study

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

Interventions

DEVICE

Mid frequency ventilation

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

DEVICE

Standard frequency ventilation

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

Sponsors & Collaborators

  • University of South Alabama

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Waldemar A Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-02
Primary Completion
2021-11-21
Completion
2024-10-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03231735 on ClinicalTrials.gov