Respiratory Distress SyndromeNCT02249143
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
A study testing CPAP and room air in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- What is being tested?
- CPAP and room air
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
- Being tested
- CPAP and room air
- Keywords
- Continuous positive airway pressure, Prematurity, Respiratory distress syndrome, Bronchopulmonary dysplasia
- Medical subject headings
- Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP and room airDevice
Also called continuous positive airway pressure
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.
| Study group | Role | What they receive |
|---|---|---|
| CPAP and room air | Active comparator | Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. Receives: Device: CPAP and room air |
| Room air | No intervention | Premature stable infants on CPAP and room air will be randomized to transition to room air alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
Secondary outcomes (3)
Measurements of Passive Respiratory Compliance in Randomized Premature Infants
Measurements of passive respiratory compliance will be done with the single breath occlusion technique.
Measured: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age
Passive Respiratory Resistance in Randomized Premature Infants
Measurements of passive respiratory resistance will be done with the single breath occlusion technique.
Measured: Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.
Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.
Characteristics of tidal flow volume loops will be measured.
Measured: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia McEvoy, Oregon Health and Science University
- Investigators
- Cindy T McEvoy, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249143
- Sponsor's protocol ID
- eIRB00010607
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2014
- Last updated
- 29 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31519441
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
- ClinicalTrials.gov ID
- NCT02249143
- Acronym / sponsor ID
- eIRB00010607
- Keywords
- Continuous positive airway pressure, Prematurity, Respiratory distress syndrome, Bronchopulmonary dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Posted 15 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP and room air | Active comparator | Device: CPAP and room airStable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks. |
| Room air | No intervention | –Premature stable infants on CPAP and room air will be randomized to transition to room air alone. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP and room airAlso: continuous positive airway pressureStable 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. | Device | CPAP and room air |
Primary outcome
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
Time frame: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
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.
3 secondary outcomes
Measurements of Passive Respiratory Compliance in Randomized Premature Infants
Time frame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age
Passive Respiratory Resistance in Randomized Premature Infants
Time frame: Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.
Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.
Time frame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31519441Lam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy T McEvoy, MD, MCR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and room air in people with Respiratory Distress Syndrome and Bronchopulmonary Dysplasia, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants (time frame: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249143, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.