PUFFOR: Pulmonary Function Using Non-invasive Forced Oscillometry

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Recruiting
CT.gov ID
NCT03346343
Collaborator
(none)
1,098
1
1
88.8
12.4

Study Details

Study Description

Brief Summary

The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome, and response to treatments given to newborn infants with lung diseases using a non-invasive airway oscillometry system.

Detailed Description

TremoFlo™ N-100 (For Investigational Use Only) Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) is a technology for measuring lung mechanics without patient effort. Pulmonary function testing using flow-volume and lung volumes is one of the most widely used tests to objectively measure lung function in adults. Such measurements are dependent on effort and coordination by the patient which is not possible for newborn infants. The minimum age for spirometry is typically 6 years to master the technique. Therefore, newborn infants usually require forced exhalation, flow interruption, and often sedation/anesthesia in order to obtain accurate pulmonary function measurements. Infant pulmonary function testing can be time-consuming and expensive to perform in newborn infants. This has limited the utilization of this potentially informative method of studying lung function. Measurements of lung function will be particularly informative during transition from having lungs filled with fluid during intra-uterine life to having lungs filled with air in extra-uterine life in preterm and term babies without lung disease, as well as in newborn infants with lung diseases including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome, and after the effects of treatments given to newborn infants with lung diseases.

The TremoFlo device uses the forced oscillation technique during spontaneous infant breathing and notably does not require any sedation to perform. The forced oscillation technique measures lung function by superimposing a gentle multi-frequency airwave onto the infant's respiratory airflow while the infant breathes spontaneously. Only a short period of breathing is required to obtain a reliable measurement of airway resistance and reactance. Oscillometry has been successfully utilized to quantify lung function in asthmatic children and adults with chronic obstructive pulmonary disease, but never previously in infants. This proposal brings this non-invasive technique of measuring lung function to the neonatal population to identify changes in respiratory mechanics between term and pre-term gestations and quantify fluctuations in infant lung function in response to disease progression and therapeutic intervention. The ease of oscillometry that only requires tidal breathing eliminates the need for patient cooperation and maneuvers that previously excluded lung function testing in the neonatal intensive care unit. This proposal will evaluate the feasibility and clinical value of oscillometry in newborns, both to detect changes in premature compared to full-term gestations as well as disease cohorts by introducing functional measures of lung function to bedside care.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1098 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This will be a single center prospective observational study with pre-specified Aims and HypothesesThis will be a single center prospective observational study with pre-specified Aims and Hypotheses
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Pulmonary Function Using Non-invasive Forced Oscillometry Respiratory Testing: A Prospective Observational Study
Actual Study Start Date :
Dec 6, 2017
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Non-invasive forced airway oscillometry

Analyze lung function using forced airway oscillometry in preterm infants and term infants with and without lung disease with both cross-sectional and longitudinal comparisons. Aim 1: Lung function in term and preterm infants without lung disease (anticipated n=264) Aim 2: Lung function in preterm infants with respiratory distress syndrome (RDS) who develop bronchopulmonary dysplasia (BPD) and preterm infants with RDS who do not develop BPD (anticipated n=264) Aim 3: Lung function measurements in infants with common neonatal lung diseases (including RDS, BPD, meconium aspiration syndrome, and transient tachypnea of the newborn) and controls without lung disease (anticipated n=570) Aim 4: Lung function in infants with lung disease before and after common therapeutic interventions

Device: Non-invasive forced airway oscillometry
This is a non-invasive device will measure lung function in spontaneously breathing infants. Infants will have a cushioned mask placed on his/her face and the device will take measurements as the infant breathes normally.

Outcome Measures

Primary Outcome Measures

  1. Area under the reactance curve (AXR) [40 weeks' postmenstrual age or discharge until 2 years]

    AXR as an overall measure of reactance quantified by oscillometry

Secondary Outcome Measures

  1. R7-20 [40 weeks' postmenstrual age or discharge until 2 years]

    Difference between resistance at 7 Hz and 20 Hz quantified by oscillometry

  2. R7 [40 weeks' postmenstrual age or discharge until 2 years]

    Resistance at 7 Hz quantified by oscillometry

  3. X7 [40 weeks' postmenstrual age or discharge until 2 years]

    Reactance at 7 Hz quantified by oscillometry

  4. R11 [40 weeks' postmenstrual age or discharge until 2 years]

    Resistance at 11 Hz quantified by oscillometry

  5. R19 [40 weeks' postmenstrual age or discharge until 2 years]

    Resistance at 19 Hz quantified by oscillometry

  6. X11 [40 weeks' postmenstrual age or discharge until 2 years]

    Reactance at 11 Hz quantified by oscillometry

  7. X19 [40 weeks' postmenstrual age or discharge until 2 years]

    Reactance at 19 Hz quantified by oscillometry

  8. Impedance R(f) [40 weeks' postmenstrual age or discharge until 2 years]

    Resistance as a function of frequency R(f) quantified by oscillometry

  9. Impedance x(f) [40 weeks' postmenstrual age or discharge until 2 years]

    Reactance as a function of frequency x(f) quantified by oscillometry

  10. Resonance frequency [40 weeks' postmenstrual age or discharge until 2 years]

    Resonance frequency quantified by oscillometry

  11. Tidal volume [40 weeks' postmenstrual age or discharge until 2 years]

    Tidal volume measured in mL/kg quantified by oscillometry

  12. Respiratory rate [40 weeks' postmenstrual age or discharge until 2 years]

    Respiratory rate in breaths per minute

  13. Longer-term pulmonary outcomes [Up to 2 years]

    Severe morbidity: respiratory support including or CPAP or ventilation or tracheostomy; moderate morbidity: supplemental oxygen; treatment with daily pulmonary medications; ≥2 rehospitalizations for respiratory illness; ≥3 episodes of wheeze ≥2 weeks apart; mild morbidity: treatment with intermittent pulmonary medications; ≥2 episodes of wheeze ≥2 weeks apart; ≥2 medical visits for respiratory illness ≥2 weeks apart; 1 rehospitalization for respiratory illness)

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 2 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Infants with gestational age at least 22 weeks at birth

  • Infants off ventilator/continuous positive airway pressure ≥ 12 hours

  • Infants whose parents/legal guardians have provided consent

Exclusion Criteria:
  • Infants with major malformation

  • Infants with a neuromuscular condition that affects respiration

  • Infants with terminal illness

  • Infants with a decision made to withhold or limit support

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35249

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Study Director: Namasivayam Ambalavanan, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Colm Travers, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT03346343
Other Study ID Numbers:
  • IRB-300000296
First Posted:
Nov 17, 2017
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022