Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

Phase 2

Completed

• Conditions: Ventilator-Induced Lung Injury; Preterm Infant; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia
• Interventions: Device: Mid frequency ventilation; Device: Standard frequency ventilation

• Registration Number: NCT03231735
• Lead Sponsor: University of Alabama at Birmingham

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 Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Study Start: 2017-08-02
• Primary Completion: 2021-11-21
• Status Verified: 2024-10
• Study Completion: 2024-10-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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Exclusion Criteria

• a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mid frequency ventilation	Mid frequency ventilation	Mid frequency ventilation delivered at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
Standard frequency ventilation	Standard frequency ventilation	Standard frequency ventilation delivered at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Primary Outcome Measures

Name	Time	Method
Alive ventilator free days	Days 1-28 after birth	The number of days alive and ventilator-free

Secondary Outcome Measures

Name	Time	Method
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 29 weeks' gestation
Air leak syndrome	Day 1-28 after birth	Rate of pulmonary interstitial emphysema and/or pneumothorax
Alive at day 28 after birth	Day 28 after birth	Number of infants alive
Alive and continuous positive airway pressure/ventilator free	Day 1-28 after birth	Number of days alive and ontinuous positive airway pressure/ventilator free
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 oxygen free	Day 1-28 after birth	Number of days alive and oxygen free
Postnatal steroids	Before 36 weeks' postmenstrual age	Rate of post natal steroids for bronchopulmonary dysplasia
Bronchopulmonary dysplasia or death	18 to 24 months after birth	Rate of moderate to severe neurodevelopmental impairment or death
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
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

Trial Locations

Locations (2)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States