Clinical trial NCT03231735: Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
Official title: A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Ventilator-Induced Lung Injury
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Preterm Infant
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University of South Alabama
First posted: 2017-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alive ventilator free days
timeFrame: Days 1-28 after birth
Secondary outcomes:
measure: Alive at day 28 after birth
timeFrame: Day 28 after birth
measure: Ventilator free
timeFrame: Day 28 after birth
measure: Bronchopulmonary dysplasia
timeFrame: Measured at 36 weeks' postmenstrual age
measure: Bronchopulmonary dysplasia
timeFrame: Measured at 36 weeks' postmenstrual age
measure: Air leak syndrome
timeFrame: Day 1-28 after birth
measure: Pulmonary hemorrhage
timeFrame: Day 1-28 after birth
measure: Severe (grade 3-4) intracranial hemorrhage
timeFrame: Day 1-30 after birth
measure: Alive and continuous positive airway pressure/ventilator free
timeFrame: Day 1-28 after birth
measure: Alive and oxygen free
timeFrame: Day 1-28 after birth
measure: Postnatal steroids
timeFrame: Before 36 weeks' postmenstrual age
measure: Necrotizing enterocolitis
timeFrame: Days 1-120 after birth
measure: Neurodevelopmental impairment
timeFrame: 18 to 24 months after birth
measure: Bronchopulmonary dysplasia or death
timeFrame: Day 1-120 after birth
measure: Neurodevelopmental impairment or death
timeFrame: Day 1-120 after birth
measure: Bronchopulmonary dysplasia or death
timeFrame: 18 to 24 months after birth
measure: Necrotizing enterocolitis or death
timeFrame: Day 1-120 after birth
measure: Death
timeFrame: Day 1-120 after birth
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
References: