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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02249143
• Other study ID #: eIRB00010607
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in the Growth Parameters Between the Randomized Premature Infants	Changes in growth parameters will be compared between randomized groups.	From randomization through discharge at about 35-37 weeks of corrected gestational age.
Other	The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.	Adverse events and serious adverse events occurring in the randomized groups will be documented carefully	From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).
Other	Corrected Gestational Age at Which Full Nipple Feeds Are Achieved	The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.	Randomization through discharge at about 35-37 weeks of corrected gestational age.
Other	Incidence of Wheezing Through One Year of Age	Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.	Discharge through one year of corrected age
Other	Cost Comparison Between Randomized Groups	Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.	Through 12 months of corrected age
Other	Days on Oxygen Between the Randomized Groups	The days of oxygen supplementation will be compared between the groups of randomized patients.	Through discharge at about 35-37 weeks of corrected gestational age
Other	Days in the Hospital	The days in the hospital will be compared between the randomized groups.	Delivery through discharge at about 35-37 weeks of corrected gestational age
Primary	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.	Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
Secondary	Measurements of Passive Respiratory Compliance in Randomized Premature Infants	Measurements of passive respiratory compliance will be done with the single breath occlusion technique.	Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age
Secondary	Passive Respiratory Resistance in Randomized Premature Infants	Measurements of passive respiratory resistance will be done with the single breath occlusion technique.	Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.
Secondary	Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.	Characteristics of tidal flow volume loops will be measured.	Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.