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

NCT02249143 | Completed Results

• 1 other identifier: eIRB00010607
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Keywords

Continuous positive airway pressure; Prematurity; Respiratory distress syndrome; Bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Measurements of Passive Respiratory Compliance in Randomized Premature Infants

  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

  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.

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

Other Outcomes (7)

• Changes in the Growth Parameters Between the Randomized Premature Infants

  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.

  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

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

Study Arms (2)

CPAP and room air

ACTIVE COMPARATOR

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

Room air

NO INTERVENTION

Premature stable infants on CPAP and room air will be randomized to transition to room air alone.

Interventions

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.

Also known as: continuous positive airway pressure

CPAP and room air

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 31519441 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Premature Birth

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Cindy McEvoy, MD
• Organization: OHSU

mcevoyc@ohsu.edu

503-494-0223

Study Officials

• Cindy T McEvoy, MD, MCR

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2017
• Last Updated: August 29, 2019
• Results First Posted: November 15, 2018

Record last verified: 2019-08

Locations

US (1)