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Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02249143
Recruitment Status : Completed
First Posted : September 25, 2014
Results First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Cynthia McEvoy, Oregon Health and Science University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Intervention Device: CPAP and room air
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CPAP and Room Air Room Air
Hide Arm/Group Description

Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.

CPAP and room air: 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.

Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Period Title: Overall Study
Started [1] 24 26 [1]
Completed 22 [2] 22 [2]
Not Completed 2 4
[1]
randomized
[2]
with technically acceptable pulmonary function tests in the neonatal intensive care unit
Arm/Group Title Active Comparator: CPAP and Room Air No Intervention: Room Air Total
Hide Arm/Group Description CPAP and room air: 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. Premature stable infants on CPAP and room air will be randomized to transition to room air alone. Total of all reporting groups
Overall Number of Baseline Participants 22 22 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
<=18 years
22
 100.0%
22
 100.0%
44
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 44 participants
Female
13
  59.1%
8
  36.4%
21
  47.7%
Male
9
  40.9%
14
  63.6%
23
  52.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 44 participants
22
 100.0%
22
 100.0%
44
 100.0%
1.Primary Outcome
Title Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
Hide Description Functional residual capacity (FRC) was measured with the nitrogen washout technique.
Time Frame Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP and Room Air Room Air
Hide Arm/Group Description:

Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.

CPAP and room air: 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.

Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
Overall Number of Participants Analyzed 22 22
Mean (Standard Deviation)
Unit of Measure: mL
FRC change from baseline to two weeks 12.6  (11.4) 6.4  (10.1)
FRC change from baseline to discharge 27.2  (12.5) 17.1  (11.7)
2.Secondary Outcome
Title Changes in the Measurements of Passive Respiratory Compliance in Randomized Premature Infants
Hide 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
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Changes in the Measurements of Passive Respiratory Resistance in Randomized Premature Infants
Hide 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.
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.
Hide 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.
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title Changes in the Growth Parameters Between the Randomized Premature Infants
Hide 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.
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title The Incidence of Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.
Hide 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).
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Corrected Gestational Age at Which Full Nipple Feeds Are Achieved
Hide 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.
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Incidence of Wheezing Through One Year of Age
Hide 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
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title Cost Comparison Between Randomized Groups
Hide 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
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title Days on Oxygen Between the Randomized Groups
Hide 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
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Days in the Hospital
Hide 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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPAP and Room Air Room Air
Hide Arm/Group Description

Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.

CPAP and room air: 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.

Premature stable infants on CPAP and room air will be randomized to transition to room air alone.
All-Cause Mortality
CPAP and Room Air Room Air
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CPAP and Room Air Room Air
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CPAP and Room Air Room Air
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/26 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Cindy McEvoy, MD
Organization: OHSU
Phone: 503-494-0223
Responsible Party: Cynthia McEvoy, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02249143     History of Changes
Other Study ID Numbers: eIRB00010607
First Submitted: August 28, 2014
First Posted: September 25, 2014
Results First Submitted: October 16, 2018
Results First Posted: November 15, 2018
Last Update Posted: November 15, 2018