Bronchopulmonary Dysplasia, Preterm Infant, Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
Conditions
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.
Interventions
DEVICEMid frequency ventilation
Mechanical ventilator used at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
DEVICEStandard frequency ventilation
Mechanical ventilator used at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.
Sponsors
University of South Alabama
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Days
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alive ventilator free days | Days 1-28 after birth | The number of days alive and ventilator-free |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free | Day 28 after birth | Number of infants ventilator free |
| Bronchopulmonary dysplasia | Measured at 36 weeks' postmenstrual age | Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation |
| Air leak syndrome | Day 1-28 after birth | Rate of pulmonary interstitial emphysema and/or pneumothorax |
| Pulmonary hemorrhage | Day 1-28 after birth | Rate of pulmonary hemorrhage |
| Severe (grade 3-4) intracranial hemorrhage | Day 1-30 after birth | Rate of severe (grade 3-4) intracranial hemorrhage in infants less than 29 weeks' gestation |
| Alive and continuous positive airway pressure/ventilator free | Day 1-28 after birth | Number of days alive and ontinuous positive airway pressure/ventilator free |
| Alive and oxygen free | Day 1-28 after birth | Number of days alive and oxygen free |
| Alive at day 28 after birth | Day 28 after birth | Number of infants alive |
| Necrotizing enterocolitis | Days 1-120 after birth | Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation |
| Neurodevelopmental impairment | 18 to 24 months after birth | Rate of moderate to severe neurodevelopmental impairment in survivors \< 27 weeks' gestation |
| Bronchopulmonary dysplasia or death | Day 1-120 after birth | Rate of Bronchopulmonary dysplasia or death |
| Neurodevelopmental impairment or death | Day 1-120 after birth | Rate of Bronchopulmonary dysplasia or death |
| Necrotizing enterocolitis or death | Day 1-120 after birth | Rate of proven necrotizing enterocolitis or death |
| Death | Day 1-120 after birth | Death before hospital discharge |
| Postnatal steroids | Before 36 weeks' postmenstrual age | Rate of post natal steroids for bronchopulmonary dysplasia |
Countries
United States
Outcome results
None listed