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

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ClinicalTrials.gov Identifier: NCT03231735
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
University of South Alabama
Information provided by (Responsible Party):
Colm Travers, 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.

Condition or disease Intervention/treatment Phase
Ventilator-Induced Lung Injury Respiratory Distress Syndrome Bronchopulmonary Dysplasia Preterm Infant Device: Mid frequency ventilation Device: Standard frequency ventilation Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. Alive ventilator free days [ Time Frame: Days 1-28 after birth ]
    The number of days alive and ventilator-free


Secondary Outcome Measures :
  1. Alive at day 28 after birth [ Time Frame: Day 28 after birth ]
    Number of infants alive

  2. Ventilator free [ Time Frame: Day 28 after birth ]
    Number of infants ventilator free

  3. Bronchopulmonary dysplasia [ Time Frame: Measured at 36 weeks' postmenstrual age ]
    Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation

  4. Bronchopulmonary dysplasia [ Time Frame: Measured at 36 weeks' postmenstrual age ]
    Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation

  5. Air leak syndrome [ Time Frame: Day 1-28 after birth ]
    Rate of pulmonary interstitial emphysema and/or pneumothorax

  6. Pulmonary hemorrhage [ Time Frame: Day 1-28 after birth ]
    Rate of pulmonary hemorrhage

  7. Severe (grade 3-4) intracranial hemorrhage [ Time Frame: Day 1-30 after birth ]
    Rate of severe (grade 3-4) intracranial hemorrhage in infants less than 29 weeks' gestation

  8. Alive and continuous positive airway pressure/ventilator free [ Time Frame: Day 1-28 after birth ]
    Number of days alive and ontinuous positive airway pressure/ventilator free

  9. Alive and oxygen free [ Time Frame: Day 1-28 after birth ]
    Number of days alive and oxygen free

  10. Postnatal steroids [ Time Frame: Before 36 weeks' postmenstrual age ]
    Rate of post natal steroids for bronchopulmonary dysplasia

  11. Necrotizing enterocolitis [ Time Frame: Days 1-120 after birth ]
    Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation

  12. Neurodevelopmental impairment [ Time Frame: 18 to 24 months after birth ]
    Rate of moderate to severe neurodevelopmental impairment in survivors < 27 weeks' gestation

  13. Bronchopulmonary dysplasia or death [ Time Frame: Day 1-120 after birth ]
    Rate of Bronchopulmonary dysplasia or death

  14. Neurodevelopmental impairment or death [ Time Frame: Day 1-120 after birth ]
    Rate of Bronchopulmonary dysplasia or death

  15. Bronchopulmonary dysplasia or death [ Time Frame: 18 to 24 months after birth ]
    Rate of moderate to severe neurodevelopmental impairment or death

  16. Necrotizing enterocolitis or death [ Time Frame: Day 1-120 after birth ]
    Rate of proven necrotizing enterocolitis or death

  17. Death [ Time Frame: Day 1-120 after birth ]
    Death before hospital discharge



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231735


Contacts
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Contact: Colm P Travers, MD 2059344680 ctravers@peds.uab.edu
Contact: Kalsang Dolma, MD 2059344680 kdolma@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Colm P Travers, MD    205-934-4680    ctravers@peds.uab.edu   
Contact: Kalsang Dolma, MD    2059344680    kdolma@uabmc.edu   
Sub-Investigator: Waldemar A Carlo, MD         
University of South Alabama Not yet recruiting
Mobile, Alabama, United States, 36604
Contact: Ramachandra Bhat, MD    251-415-1000    rbhat@health.southalabama.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
University of South Alabama
Investigators
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Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham

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Responsible Party: Colm Travers, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03231735     History of Changes
Other Study ID Numbers: F160701002
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Injury
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries