Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

Completed · Phase 2/Phase 3

Conditions studied: Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Preterm Infant

In brief

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.

Key facts

Study ID

NCT03231735

Run by

University of Alabama at Birmingham

People needed

60

Starts

2017-08-02

Expected to finish

2024-10-10

Last updated by the study team

2024-10-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.