Ventilator-Induced Lung InjuryPhase 2/3MIDASNCT03231735
Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
A Phase 2/3 study testing Mid frequency ventilation and Standard frequency ventilation in people with Ventilator-Induced Lung Injury and Respiratory Distress Syndrome, run by University of Alabama at Birmingham at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- What is being tested?
- Mid frequency ventilation and Standard frequency ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2017to 10 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of South Alabama
Mobile, Alabama, 36604
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Preterm Infant
- Being tested
- Mid frequency ventilation, Standard frequency ventilation
- Medical subject headings
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mid frequency ventilationDevice
Mechanical ventilator used at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
Standard frequency ventilationDevice
Mechanical ventilator used at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.
| Study group | Role | What they receive |
|---|---|---|
| Mid frequency ventilation | Other | Mid frequency ventilation delivered at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support. Receives: Device: Mid frequency ventilation |
| Standard frequency ventilation | Other | Standard frequency ventilation delivered at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support. Receives: Device: Standard frequency ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive ventilator free days
The number of days alive and ventilator-free
Measured: Days 1-28 after birth
Secondary outcomes (17)
Alive at day 28 after birth
Number of infants alive
Measured: Day 28 after birth
Ventilator free
Number of infants ventilator free
Measured: Day 28 after birth
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation
Measured: Measured at 36 weeks' postmenstrual age
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation
Measured: Measured at 36 weeks' postmenstrual age
Air leak syndrome
Rate of pulmonary interstitial emphysema and/or pneumothorax
Measured: Day 1-28 after birth
Pulmonary hemorrhage
Rate of pulmonary hemorrhage
Measured: 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
Measured: Day 1-30 after birth
Alive and continuous positive airway pressure/ventilator free
Number of days alive and ontinuous positive airway pressure/ventilator free
Measured: Day 1-28 after birth
Alive and oxygen free
Number of days alive and oxygen free
Measured: Day 1-28 after birth
Postnatal steroids
Rate of post natal steroids for bronchopulmonary dysplasia
Measured: Before 36 weeks' postmenstrual age
Necrotizing enterocolitis
Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation
Measured: Days 1-120 after birth
Neurodevelopmental impairment
Rate of moderate to severe neurodevelopmental impairment in survivors < 27 weeks' gestation
Measured: 18 to 24 months after birth
Bronchopulmonary dysplasia or death
Rate of Bronchopulmonary dysplasia or death
Measured: Day 1-120 after birth
Neurodevelopmental impairment or death
Rate of Bronchopulmonary dysplasia or death
Measured: Day 1-120 after birth
Bronchopulmonary dysplasia or death
Rate of moderate to severe neurodevelopmental impairment or death
Measured: 18 to 24 months after birth
Necrotizing enterocolitis or death
Rate of proven necrotizing enterocolitis or death
Measured: Day 1-120 after birth
Death
Death before hospital discharge
Measured: Day 1-120 after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start2 Aug 2017
- Primary completion21 Nov 2021
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-Induced Lung InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Alabama
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231735
- Sponsor's protocol ID
- F160701002
- Acronym
- MIDAS
- Status last verified
- Oct 2024
- First submitted
- 25 Jul 2017
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT03231735
- Acronym / sponsor ID
- MIDAS / F160701002
- Conditions
- Ventilator-Induced Lung Injury, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Preterm Infant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of South Alabama
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mid frequency ventilation | Other | Device: Mid frequency ventilationMid frequency ventilation delivered at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support. |
| Standard frequency ventilation | Other | Device: Standard frequency ventilationStandard frequency ventilation delivered at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- a major malformation, a neuromuscular condition that affects respiration, or terminal illness or decision to withhold or limit support.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mid frequency ventilationMechanical ventilator used at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support. | Device | Mid frequency ventilation |
| Standard frequency ventilationMechanical ventilator used at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support. | Device | Standard frequency ventilation |
Primary outcome
Alive ventilator free days
Time frame: Days 1-28 after birth
The number of days alive and ventilator-free
17 secondary outcomes
Alive at day 28 after birth
Time frame: Day 28 after birth
Ventilator free
Time frame: Day 28 after birth
Bronchopulmonary dysplasia
Time frame: Measured at 36 weeks' postmenstrual age
Bronchopulmonary dysplasia
Time frame: Measured at 36 weeks' postmenstrual age
Air leak syndrome
Time frame: Day 1-28 after birth
Pulmonary hemorrhage
Time frame: Day 1-28 after birth
Severe (grade 3-4) intracranial hemorrhage
Time frame: Day 1-30 after birth
Alive and continuous positive airway pressure/ventilator free
Time frame: Day 1-28 after birth
Alive and oxygen free
Time frame: Day 1-28 after birth
Postnatal steroids
Time frame: Before 36 weeks' postmenstrual age
Necrotizing enterocolitis
Time frame: Days 1-120 after birth
Neurodevelopmental impairment
Time frame: 18 to 24 months after birth
Bronchopulmonary dysplasia or death
Time frame: Day 1-120 after birth
Neurodevelopmental impairment or death
Time frame: Day 1-120 after birth
Bronchopulmonary dysplasia or death
Time frame: 18 to 24 months after birth
Necrotizing enterocolitis or death
Time frame: Day 1-120 after birth
Death
Time frame: Day 1-120 after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waldemar A Carlo, MD study director
University of Alabama at Birmingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mid frequency ventilation and Standard frequency ventilation in people with Ventilator-Induced Lung Injury and Respiratory Distress Syndrome, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alive ventilator free days (time frame: Days 1-28 after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.