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Mechanical Ventilation

Ventilation Strategies for Neonatal Respiratory Distress Syndrome (MIDAS Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Inborn or outborn infants transferred to this center before 48 hours after birth
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 to 24 months after birth
Awards & highlights

MIDAS Trial Summary

This trial compares two different breathing strategies for preterm infants with respiratory distress. The goal is to see if a faster breathing rate will help them avoid complications like ventilator-induced lung injury.

Who is the study for?
This trial is for preterm infants born between 23 and nearly 37 weeks who need help breathing within the first 48 hours after birth. They must be on a ventilator with a rate of ≤80 breaths per minute and have received surfactant treatment. Infants with major malformations, terminal illnesses, or neuromuscular conditions affecting respiration cannot participate.Check my eligibility
What is being tested?
The study compares two ventilation strategies in premature babies with respiratory distress: mid frequency ventilation (60-150 breaths/min) versus standard frequency (20-60 breaths/min). The goal is to see if higher rates improve survival without needing a ventilator and reduce lung injury from the ventilator.See study design
What are the potential side effects?
Potential side effects may include complications related to different breathing rates such as further lung damage or issues adjusting to either high or low-frequency ventilation, but specific side effects will depend on each infant's condition.

MIDAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My baby was transferred to this center within 48 hours of birth.
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My baby was put on a breathing machine within 48 hours of birth due to breathing issues and received surfactant.
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My child's legal guardians have agreed to enroll them in the study.

MIDAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 to 24 months after birth
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 to 24 months after birth for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alive ventilator free days
Secondary outcome measures
Air leak syndrome
Alive and continuous positive airway pressure/ventilator free
Alive and oxygen free
+12 more

MIDAS Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard frequency ventilationExperimental Treatment1 Intervention
Standard frequency ventilation delivered at rates < 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.
Group II: Mid frequency ventilationExperimental Treatment1 Intervention
Mid frequency ventilation delivered at rates > 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,566 Previous Clinical Trials
2,268,327 Total Patients Enrolled
6 Trials studying Respiratory Distress Syndrome
1,320 Patients Enrolled for Respiratory Distress Syndrome
University of South AlabamaOTHER
42 Previous Clinical Trials
15,874 Total Patients Enrolled
Waldemar A Carlo, MDStudy DirectorUniversity of Alabama at Birmingham
26 Previous Clinical Trials
127,209 Total Patients Enrolled
2 Trials studying Respiratory Distress Syndrome
50 Patients Enrolled for Respiratory Distress Syndrome

Media Library

Mid frequency ventilation (Mechanical Ventilation) Clinical Trial Eligibility Overview. Trial Name: NCT03231735 — Phase 2 & 3
Respiratory Distress Syndrome Research Study Groups: Mid frequency ventilation, Standard frequency ventilation
Respiratory Distress Syndrome Clinical Trial 2023: Mid frequency ventilation Highlights & Side Effects. Trial Name: NCT03231735 — Phase 2 & 3
Mid frequency ventilation (Mechanical Ventilation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03231735 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I review the screening process to see if I qualify for this research project?

"This clinical trial is only for infants who have respiratory distress syndrome and are between 1 and 3 days old--60 infants in total will be accepted."

Answered by AI

Is this experiment accessible to individuals below the age of 40?

"According to the stated eligibility requirements, patients that fall between 1 day to 3 days old can apply to participate in this clinical trial. Out of the 1152 trials available for patients over the age of 65, this trial is one of the 483 trials available to patients under the age of 18."

Answered by AI
~8 spots leftby Mar 2025