Back to resultsDuration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
Primary Purpose
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP and room air
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome focused on measuring Continuous positive airway pressure, Prematurity, Respiratory distress syndrome, Bronchopulmonary dysplasia
Eligibility Criteria
Inclusion Criteria:
- Gestational age at birth <33 weeks
- Required CPAP for a minimum of 24 hours for respiratory distress
- Patient on CPAP and room air at time of randomization
Exclusion Criteria:
- Complex congenital heart disease other than patent ductus arteriosus or atrial septal defect
- Major malformations or chromosomal anomalies
- Multiple gestation greater than twins
- Culture proven sepsis or unstable at time of randomization
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
CPAP and room air
Room air
Arm Description
Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.
Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Outcomes
Primary Outcome Measures
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation <10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.
Secondary Outcome Measures
Measurements of Passive Respiratory Compliance in Randomized Premature Infants
Measurements of passive respiratory compliance will be done with the single breath occlusion technique.
Passive Respiratory Resistance in Randomized Premature Infants
Measurements of passive respiratory resistance will be done with the single breath occlusion technique.
Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.
Characteristics of tidal flow volume loops will be measured.
Full Information
NCT ID
NCT02249143
First Posted
August 28, 2014
Last Updated
August 26, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT02249143
Brief Title
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
Official Title
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an increased functional residual capacity (at the end of the two week study period and prior to discharge) compared to those randomized to room air.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
Keywords
Continuous positive airway pressure, Prematurity, Respiratory distress syndrome, Bronchopulmonary dysplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP and room air
Arm Type
Active Comparator
Arm Description
Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.
Arm Title
Room air
Arm Type
No Intervention
Arm Description
Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Intervention Type
Device
Intervention Name(s)
CPAP and room air
Other Intervention Name(s)
continuous positive airway pressure
Intervention Description
Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.
Primary Outcome Measure Information:
Title
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
Description
Functional residual capacity (FRC) was measured with the nitrogen washout technique. For the nitrogen washout technique, calibration is done with 2 known volumes, and a calibration line was constructed for the system at the specific flow rate and used to correlate the nitrogen washed out to the infant's FRC. The system corrected for dead space and corrected the FRC to body temperature, pressure, and water-saturated conditions. Acceptance criteria included: 1) infant supine and quietly asleep; 2) test initiated at end expiration; 3) no evidence of leak on tracing of the washout; 4) consistent tracings; 5) at least 2-3 measurements with a coefficient of variation <10%. These are testing and acceptance criteria outlined by the American Thoracic Society and European Respiratory Society.
Time Frame
Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
Secondary Outcome Measure Information:
Title
Measurements of Passive Respiratory Compliance in Randomized Premature Infants
Description
Measurements of passive respiratory compliance will be done with the single breath occlusion technique.
Time Frame
Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age
Title
Passive Respiratory Resistance in Randomized Premature Infants
Description
Measurements of passive respiratory resistance will be done with the single breath occlusion technique.
Time Frame
Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.
Title
Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.
Description
Characteristics of tidal flow volume loops will be measured.
Time Frame
Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.
Other Pre-specified Outcome Measures:
Title
Changes in the Growth Parameters Between the Randomized Premature Infants
Description
Changes in growth parameters will be compared between randomized groups.
Time Frame
From randomization through discharge at about 35-37 weeks of corrected gestational age.
Title
The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.
Description
Adverse events and serious adverse events occurring in the randomized groups will be documented carefully
Time Frame
From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).
Title
Corrected Gestational Age at Which Full Nipple Feeds Are Achieved
Description
The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.
Time Frame
Randomization through discharge at about 35-37 weeks of corrected gestational age.
Title
Incidence of Wheezing Through One Year of Age
Description
Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.
Time Frame
Discharge through one year of corrected age
Title
Cost Comparison Between Randomized Groups
Description
Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.
Time Frame
Through 12 months of corrected age
Title
Days on Oxygen Between the Randomized Groups
Description
The days of oxygen supplementation will be compared between the groups of randomized patients.
Time Frame
Through discharge at about 35-37 weeks of corrected gestational age
Title
Days in the Hospital
Description
The days in the hospital will be compared between the randomized groups.
Time Frame
Delivery through discharge at about 35-37 weeks of corrected gestational age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age at birth <33 weeks
Required CPAP for a minimum of 24 hours for respiratory distress
Patient on CPAP and room air at time of randomization
Exclusion Criteria:
Complex congenital heart disease other than patent ductus arteriosus or atrial septal defect
Major malformations or chromosomal anomalies
Multiple gestation greater than twins
Culture proven sepsis or unstable at time of randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy T McEvoy, MD, MCR
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31519441
Citation
Lam R, Schilling D, Scottoline B, Platteau A, Niederhausen M, Lund KC, Schelonka RL, MacDonald KD, McEvoy CT. The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial. J Pediatr. 2020 Feb;217:66-72.e1. doi: 10.1016/j.jpeds.2019.07.074. Epub 2019 Sep 10.
Results Reference
derived
Learn more about this trial
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
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