Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bronchopulmonary Dysplasia
- Preterm Infant
- Respiratory Distress Syndrome
- Ventilator Induced Lung Injury
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 3 years
- Gender
- Both males and females
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 ventilato...
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.
Tracking Information
- NCT #
- NCT03231735
- Collaborators
- University of South Alabama
- Investigators
- Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham