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

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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