Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

Bronchopulmonary Dysplasia Clinical Trial

— MIDAS  

Official title:

A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03231735
• Other study ID #: F160701002
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2, 2017
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: November 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Lung Injury
• Preterm Infant
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome
• Ventilator-Induced Lung Injury

Intervention

Device:
• Mid frequency ventilation
Mechanical ventilator used at rates > 60 per minute and = 150 per minute, with patient triggered ventilation and pressure support.
• Standard frequency ventilation
Mechanical ventilator used at rates < 60 per minute and = 20 per minute, with patient triggered ventilation and pressure support.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of South Alabama	Mobile	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	University of South Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alive ventilator free days	The number of days alive and ventilator-free	Days 1-28 after birth
Secondary	Alive at day 28 after birth	Number of infants alive	Day 28 after birth
Secondary	Ventilator free	Number of infants ventilator free	Day 28 after birth
Secondary	Bronchopulmonary dysplasia	Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation	Measured at 36 weeks' postmenstrual age
Secondary	Bronchopulmonary dysplasia	Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation	Measured at 36 weeks' postmenstrual age
Secondary	Air leak syndrome	Rate of pulmonary interstitial emphysema and/or pneumothorax	Day 1-28 after birth
Secondary	Pulmonary hemorrhage	Rate of pulmonary hemorrhage	Day 1-28 after birth
Secondary	Severe (grade 3-4) intracranial hemorrhage	Rate of severe (grade 3-4) intracranial hemorrhage in infants less than 29 weeks' gestation	Day 1-30 after birth
Secondary	Alive and continuous positive airway pressure/ventilator free	Number of days alive and ontinuous positive airway pressure/ventilator free	Day 1-28 after birth
Secondary	Alive and oxygen free	Number of days alive and oxygen free	Day 1-28 after birth
Secondary	Postnatal steroids	Rate of post natal steroids for bronchopulmonary dysplasia	Before 36 weeks' postmenstrual age
Secondary	Necrotizing enterocolitis	Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation	Days 1-120 after birth
Secondary	Neurodevelopmental impairment	Rate of moderate to severe neurodevelopmental impairment in survivors < 27 weeks' gestation	18 to 24 months after birth
Secondary	Bronchopulmonary dysplasia or death	Rate of Bronchopulmonary dysplasia or death	Day 1-120 after birth
Secondary	Neurodevelopmental impairment or death	Rate of Bronchopulmonary dysplasia or death	Day 1-120 after birth
Secondary	Bronchopulmonary dysplasia or death	Rate of moderate to severe neurodevelopmental impairment or death	18 to 24 months after birth
Secondary	Necrotizing enterocolitis or death	Rate of proven necrotizing enterocolitis or death	Day 1-120 after birth
Secondary	Death	Death before hospital discharge	Day 1-120 after birth