Brief Title
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
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.
Study Type
Interventional
Primary Outcome
Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants
Secondary Outcome
Measurements of Passive Respiratory Compliance in Randomized Premature Infants
Condition
Respiratory Distress Syndrome
Intervention
CPAP and room air
Study Arms / Comparison Groups
CPAP and room air
Description: Stable premature infants on CPAP and room air will be randomized to stay on CPAP for an additional two weeks.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
50
Start Date
September 2014
Completion Date
September 2017
Primary Completion Date
May 2016
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
Gender
All
Ages
N/A - 1 Year
Accepts Healthy Volunteers
No
Contacts
Cindy T McEvoy, MD, MCR, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02249143
Organization ID
eIRB00010607
Responsible Party
Principal Investigator
Study Sponsor
Oregon Health and Science University
Study Sponsor
Cindy T McEvoy, MD, MCR, Principal Investigator, Oregon Health and Science University
Verification Date
August 2019