Clinical trial NCT02249143: 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
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Keywords: Continuous positive airway pressure
Prematurity
Respiratory distress syndrome
Bronchopulmonary dysplasia
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 50
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
timeFrame: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).
Secondary outcomes:
measure: Measurements of Passive Respiratory Compliance in Randomized Premature Infants
timeFrame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age
measure: Passive Respiratory Resistance in Randomized Premature Infants
timeFrame: Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.
measure: Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.
timeFrame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.
Other outcomes:
measure: Changes in the Growth Parameters Between the Randomized Premature Infants
timeFrame: From randomization through discharge at about 35-37 weeks of corrected gestational age.
measure: The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.
timeFrame: From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).
measure: Corrected Gestational Age at Which Full Nipple Feeds Are Achieved
timeFrame: Randomization through discharge at about 35-37 weeks of corrected gestational age.
measure: Incidence of Wheezing Through One Year of Age
timeFrame: Discharge through one year of corrected age
measure: Cost Comparison Between Randomized Groups
timeFrame: Through 12 months of corrected age
measure: Days on Oxygen Between the Randomized Groups
timeFrame: Through discharge at about 35-37 weeks of corrected gestational age
measure: Days in the Hospital
timeFrame: Delivery through discharge at about 35-37 weeks of corrected gestational age
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Cindy T McEvoy, MD, MCR
role: PRINCIPAL_INVESTIGATOR
References:
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.