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

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 Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome; Bronchopulmonary Dysplasia
• Intervention / Treatment: Device: CPAP and room air

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP and room air; Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.	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.; Other Names: continuous positive airway pressure
No Intervention: Room air; Premature stable infants on CPAP and room air will be randomized to transition to room air alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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).
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.
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
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
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
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Cindy T McEvoy, MD, MCR, Oregon Health and Science University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: September 22, 2014
• First Posted (Estimate): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Prematurity; Bronchopulmonary dysplasia; Continuous positive airway pressure; Respiratory distress syndrome
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia
• Other Study ID Numbers: eIRB00010607