A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 4
- Primary Endpoint
- Alive ventilator free days
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 3 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.
Outcomes
Primary Outcomes
Alive ventilator free days
Time Frame: Days 1-28 after birth
The number of days alive and ventilator-free
Secondary Outcomes
- Ventilator free(Day 28 after birth)
- Air leak syndrome(Day 1-28 after birth)
- Alive and continuous positive airway pressure/ventilator free(Day 1-28 after birth)
- Alive at day 28 after birth(Day 28 after birth)
- Pulmonary hemorrhage(Day 1-28 after birth)
- Severe (grade 3-4) intracranial hemorrhage(Day 1-30 after birth)
- Alive and oxygen free(Day 1-28 after birth)
- Postnatal steroids(Before 36 weeks' postmenstrual age)
- Bronchopulmonary dysplasia or death(18 to 24 months after birth)
- Necrotizing enterocolitis(Days 1-120 after birth)
- Neurodevelopmental impairment(18 to 24 months after birth)
- Neurodevelopmental impairment or death(Day 1-120 after birth)
- Necrotizing enterocolitis or death(Day 1-120 after birth)
- Death(Day 1-120 after birth)
- Bronchopulmonary dysplasia(Measured at 36 weeks' postmenstrual age)
Investigators
Colm Travers
Principal Investigator
University of Alabama at Birmingham