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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

Tracking Information
First Submitted Date  ICMJE July 25, 2017
First Posted Date  ICMJE July 27, 2017
Last Update Posted Date August 16, 2019
Actual Study Start Date  ICMJE August 2, 2017
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
Alive ventilator free days [ Time Frame: Days 1-28 after birth ]
The number of days alive and ventilator-free
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03231735 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2017)
  • Alive at day 28 after birth [ Time Frame: Day 28 after birth ]
    Number of infants alive
  • Ventilator free [ Time Frame: Day 28 after birth ]
    Number of infants ventilator free
  • Bronchopulmonary dysplasia [ Time Frame: Measured at 36 weeks' postmenstrual age ]
    Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation
  • Bronchopulmonary dysplasia [ Time Frame: Measured at 36 weeks' postmenstrual age ]
    Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation
  • Air leak syndrome [ Time Frame: Day 1-28 after birth ]
    Rate of pulmonary interstitial emphysema and/or pneumothorax
  • Pulmonary hemorrhage [ Time Frame: Day 1-28 after birth ]
    Rate of pulmonary hemorrhage
  • 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
  • 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
  • Alive and oxygen free [ Time Frame: Day 1-28 after birth ]
    Number of days alive and oxygen free
  • Postnatal steroids [ Time Frame: Before 36 weeks' postmenstrual age ]
    Rate of post natal steroids for bronchopulmonary dysplasia
  • Necrotizing enterocolitis [ Time Frame: Days 1-120 after birth ]
    Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation
  • Neurodevelopmental impairment [ Time Frame: 18 to 24 months after birth ]
    Rate of moderate to severe neurodevelopmental impairment in survivors < 27 weeks' gestation
  • Bronchopulmonary dysplasia or death [ Time Frame: Day 1-120 after birth ]
    Rate of Bronchopulmonary dysplasia or death
  • Neurodevelopmental impairment or death [ Time Frame: Day 1-120 after birth ]
    Rate of Bronchopulmonary dysplasia or death
  • Bronchopulmonary dysplasia or death [ Time Frame: 18 to 24 months after birth ]
    Rate of moderate to severe neurodevelopmental impairment or death
  • Necrotizing enterocolitis or death [ Time Frame: Day 1-120 after birth ]
    Rate of proven necrotizing enterocolitis or death
  • Death [ Time Frame: Day 1-120 after birth ]
    Death before hospital discharge
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Alive at day 28 after birth [ Time Frame: Day 28 after birth ]
    Number of infants alive
  • Ventilator free [ Time Frame: Day 28 after birth ]
    Number of infants ventilator free
  • Bronchopulmonary dysplasia [ Time Frame: Measured at 36 weeks' postmenstrual age ]
    Bronchopulmonary dysplasia in preterm infants less than 32 weeks' gestation
  • Bronchopulmonary dysplasia [ Time Frame: Measured at 36 weeks' postmenstrual age ]
    Bronchopulmonary dysplasia in preterm infants less than 29 weeks' gestation
  • Air leak syndrome [ Time Frame: Day 1-28 after birth ]
    Rate of pulmonary interstitial emphysema and/or pneumothorax
  • Pulmonary hemorrhage [ Time Frame: Day 1-28 after birth ]
    Rate of pulmonary hemorrhage
  • 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
  • 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
  • Alive and oxygen free [ Time Frame: Day 1-28 after birth ]
    Number of days alive and oxygen free
  • Postnatal steroids [ Time Frame: Before 36 weeks' postmenstrual age ]
    Rate of post natal steroids for bronchopulmonary dysplasia
  • Necrotizing enterocolitis [ Time Frame: Days 1-120 after birth ]
    Rate of proven necrotizing enterocolitis (NEC) in infants less than 29 weeks' gestation
  • Neurodevelopmental impairment [ Time Frame: 18 to 24 months after birth ]
    Rate of moderate to severe neurodevelopmental impairment in survivors < 27 weeks' gestation
  • Bronchopulmonary dysplasia or death [ Time Frame: Day 1-120 after birth ]
    Rate of Bronchopulmonary dysplasia or death
  • Neurodevelopmental impairment or death [ Time Frame: Day 1-120 after birth ]
    Rate of Bronchopulmonary dysplasia or death
  • Bronchopulmonary dysplasia or death [ Time Frame: 18 to 24 months after birth ]
    e of moderate to severe neurodevelopmental impairment or death
  • Necrotizing enterocolitis or death [ Time Frame: Day 1-120 after birth ]
    Rate of proven necrotizing enterocolitis or death
  • Death [ Time Frame: Day 1-120 after birth ]
    Death before hospital discharge
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
Official Title  ICMJE A Randomized Controlled Trial of Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Ventilator-Induced Lung Injury
  • Respiratory Distress Syndrome
  • Bronchopulmonary Dysplasia
  • Preterm Infant
Intervention  ICMJE
  • Device: Mid frequency ventilation
    Mechanical ventilator used at rates > 60 per minute and ≤ 150 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.
Study Arms  ICMJE
  • Mid frequency ventilation
    Mid frequency ventilation delivered at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.
    Intervention: Device: Mid 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.
    Intervention: Device: Standard frequency ventilation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Colm P Travers, MD 2059344680 ctravers@peds.uab.edu
Contact: Kalsang Dolma, MD 2059344680 kdolma@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03231735
Other Study ID Numbers  ICMJE F160701002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Colm Travers, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE University of South Alabama
Investigators  ICMJE
Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP