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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Mechanical ventilator used at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
Mechanical ventilator used at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama
Mobile, Alabama, United States
Alive ventilator free days
The number of days alive and ventilator-free
Time frame: Days 1-28 after birth
Alive at day 28 after birth
Number of infants alive
Time frame: Day 28 after birth
Ventilator free
Number of infants ventilator free
Time frame: Day 28 after birth
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation
Time frame: Measured at 36 weeks' postmenstrual age
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation
Time frame: Measured at 36 weeks' postmenstrual age
Air leak syndrome
Rate of pulmonary interstitial emphysema and/or pneumothorax
Time frame: Day 1-28 after birth
Pulmonary hemorrhage
Rate of pulmonary hemorrhage
Time frame: Day 1-28 after birth
Severe (grade 3-4) intracranial hemorrhage
Rate of severe (grade 3-4) intracranial hemorrhage in infants less than 29 weeks' gestation
Time frame: Day 1-30 after birth
Alive and continuous positive airway pressure/ventilator free
Number of days alive and ontinuous positive airway pressure/ventilator free
Time frame: Day 1-28 after birth
Alive and oxygen free
Number of days alive and oxygen free
Time frame: Day 1-28 after birth
Postnatal steroids
Rate of post natal steroids for bronchopulmonary dysplasia
Time frame: Before 36 weeks' postmenstrual age
Necrotizing enterocolitis
Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation
Time frame: Days 1-120 after birth
Neurodevelopmental impairment
Rate of moderate to severe neurodevelopmental impairment in survivors \< 27 weeks' gestation
Time frame: 18 to 24 months after birth
Bronchopulmonary dysplasia or death
Rate of Bronchopulmonary dysplasia or death
Time frame: Day 1-120 after birth
Neurodevelopmental impairment or death
Rate of Bronchopulmonary dysplasia or death
Time frame: Day 1-120 after birth
Bronchopulmonary dysplasia or death
Rate of moderate to severe neurodevelopmental impairment or death
Time frame: 18 to 24 months after birth
Necrotizing enterocolitis or death
Rate of proven necrotizing enterocolitis or death
Time frame: Day 1-120 after birth
Death
Death before hospital discharge
Time frame: Day 1-120 after birth
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