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Completed

NCT Number: NCT03231735

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mid frequency ventilation

Device

Mechanical ventilator used at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.

Standard frequency ventilation

Device

Mechanical ventilator used at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Primary outcomes

  1. Alive ventilator free days

    Time frame: Days 1-28 after birth

    The number of days alive and ventilator-free

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • University of South Alabama

Registry information

Official study title

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

Acronym: MIDAS

Important dates

Study start
2017
Primary completion
2021
Study completion
2024
First posted
Jul 27, 2017
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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