NCT03231735

Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

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.

Detailed description

In preterm infants with respiratory distress syndrome (RDS) who are ventilated in the first 48 hours after birth, mid frequency ventilation (MFV) strategy, compared with standard frequency ventilation (SFV) strategy, in the first week after birth, will increase the number of days alive and ventilator-free in the 28 days after birth. This will be a randomized controlled trial with a 1:1 parallel allocation of infants to MFV or SFV using stratified permuted block design. Randomization will be stratified by gestational age (≥ 23 weeks to ˂ 26 weeks, ≥ 26 weeks to ≤ 28+6/7 (less than 29 weeks), and 29+0/7 to 36+6/7). Randomization of twins and higher orders (when eligible) will be to the same group. Inborn and outborn infants who are receiving assisted ventilation for RDS in the first 48 hours after birth will be included in this study. Infants with any of the following: a major malformation, a neuromuscular condition that affects respiration, terminal illness or decision to withhold or limit support will not be eligible. Infants will be randomized to MFV versus SFV. MFV delivered at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support. SFV delivered at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-02
• Primary completion: 2021-11-21
• Completion: 2024-10-10
• First posted: 2017-07-27
• Last updated: 2024-10-15

Locations

2 sites across 1 country: United States