Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome (MIDAS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Ventilator-Induced Lung Injury; Preterm Infant
• Intervention / Treatment: Device: Mid frequency ventilation; Device: Standard frequency ventilation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
    • Mobile, Alabama, United States, 36604
      • University of South Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 days (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mid frequency ventilation; Mid frequency ventilation delivered at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.	Device: Mid frequency ventilation; Mechanical ventilator used at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
Other: Standard frequency ventilation; Standard frequency ventilation delivered at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.	Device: Standard frequency ventilation; Mechanical ventilator used at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alive ventilator free days	The number of days alive and ventilator-free	Days 1-28 after birth

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University of South Alabama
• Investigators: Study Director: Waldemar A Carlo, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): November 21, 2021
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: July 25, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Injury; Bronchopulmonary Dysplasia; Ventilator-Induced Lung Injury
• Other Study ID Numbers: F160701002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No