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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 3; Phase 2

Conditions: Respiratory Distress Syndrome; Preterm Infant; Bronchopulmonary Dysplasia; Ventilator-Induced Lung Injury

Treatments: Device: Mid frequency ventilation; Device: Standard frequency ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03231735

F160701002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Mid frequency ventilation

Other group

Description:

Mid frequency ventilation delivered at rates \> 60 per minute and ≤ 150 per minute, with patient triggered ventilation and pressure support.

Treatment:

Device: Mid frequency ventilation

Standard frequency ventilation

Other group

Description:

Standard frequency ventilation delivered at rates \< 60 per minute and ≥ 20 per minute, with patient triggered ventilation and pressure support.

Treatment:

Device: Standard frequency ventilation