Mid and Standard Frequency Ventilation in Infants With Respiratory Distress Syndrome



Status:Recruiting
Conditions:Bronchitis, Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any
Updated:8/11/2018
Start Date:August 2, 2017
End Date:July 31, 2019
Contact:Colm P Travers, MD
Email:ctravers@peds.uab.edu
Phone:2059344680

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A Randomized Controlled Trial of 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.

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.

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.
We found this trial at
2
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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307 N University Blvd
Mobile, Alabama 36688
(251) 460-6101
Phone: 251-415-1000
University of South Alabama "University of South Alabama is a public institution that was founded...
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Mobile, AL
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