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Completed

NCT Number: NCT02249143

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.

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Key information

Conditions

Respiratory Distress Syndrome Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP and room air

Device

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

Primary outcomes

  1. Changes in the Measurements of Functional Residual Capacity (FRC) in Randomized Premature Infants

    Time frame: Just prior to randomization, two weeks later and at discharge (an average of 34 to 37 weeks of corrected gestational age).

    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.

Secondary outcomes

  1. Measurements of Passive Respiratory Compliance in Randomized Premature Infants

    Time frame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age

    Measurements of passive respiratory compliance will be done with the single breath occlusion technique.

  2. Passive Respiratory Resistance in Randomized Premature Infants

    Time frame: Just prior to randomization, two weeks after randomization, and at discharge at about 35-37 weeks of corrected gestational age.

    Measurements of passive respiratory resistance will be done with the single breath occlusion technique.

  3. Measurements of Tidal Flow Volume Loops Will be Done in the Randomized Premature Infants.

    Time frame: Just before randomization, two weeks later, and at discharge at about 35-37 weeks of corrected gestational age.

    Characteristics of tidal flow volume loops will be measured.

Other outcomes

  1. Changes in the Growth Parameters Between the Randomized Premature Infants

    Time frame: From randomization through discharge at about 35-37 weeks of corrected gestational age.

    Changes in growth parameters will be compared between randomized groups.

  2. The Number of Participants With Adverse Events and Serious Adverse Events in the Randomized Groups of Premature Infants.

    Time frame: From randomization through discharge from the neonatal intensive care unit (an average of 35 to 37 weeks of corrected gestational age).

    Adverse events and serious adverse events occurring in the randomized groups will be documented carefully

  3. Corrected Gestational Age at Which Full Nipple Feeds Are Achieved

    Time frame: Randomization through discharge at about 35-37 weeks of corrected gestational age.

    The corrected gestational age at which full nipple feeds are achieved will be compared between the randomized groups.

  4. Incidence of Wheezing Through One Year of Age

    Time frame: Discharge through one year of corrected age

    Incidence of wheezing will be compared through one year of corrected gestational age between the randomized groups.

  5. Cost Comparison Between Randomized Groups

    Time frame: Through 12 months of corrected age

    Cost comparison through 12 months of corrected gestational age between the randomized groups per percent improvement in FRC measured at discharge between the groups.

  6. Days on Oxygen Between the Randomized Groups

    Time frame: Through discharge at about 35-37 weeks of corrected gestational age

    The days of oxygen supplementation will be compared between the groups of randomized patients.

  7. Days in the Hospital

    Time frame: Delivery through discharge at about 35-37 weeks of corrected gestational age

    The days in the hospital will be compared between the randomized groups.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Sep 25, 2014
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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