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Pulmonary Function Using Non-invasive Forced Oscillometry (PUFFOR)

Primary Purpose

Infant, Premature, Diseases, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-invasive forced airway oscillometry
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infant, Premature, Diseases

Eligibility Criteria

1 Day - 2 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-invasive forced airway oscillometry

Arm Description

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

Outcomes

Primary Outcome Measures

Area under the reactance curve (AXR)
AXR as an overall measure of reactance quantified by oscillometry

Secondary Outcome Measures

R7-20
Difference between resistance at 7 Hz and 20 Hz quantified by oscillometry
R7
Resistance at 7 Hz quantified by oscillometry
X7
Reactance at 7 Hz quantified by oscillometry
R11
Resistance at 11 Hz quantified by oscillometry
R19
Resistance at 19 Hz quantified by oscillometry
X11
Reactance at 11 Hz quantified by oscillometry
X19
Reactance at 19 Hz quantified by oscillometry
Impedance R(f)
Resistance as a function of frequency R(f) quantified by oscillometry
Impedance x(f)
Reactance as a function of frequency x(f) quantified by oscillometry
Resonance frequency
Resonance frequency quantified by oscillometry
Tidal volume
Tidal volume measured in mL/kg quantified by oscillometry
Respiratory rate
Respiratory rate in breaths per minute
Longer-term pulmonary outcomes
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)

Full Information

First Posted
November 10, 2017
Last Updated
March 15, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03346343
Brief Title
Pulmonary Function Using Non-invasive Forced Oscillometry
Acronym
PUFFOR
Official Title
Pulmonary Function Using Non-invasive Forced Oscillometry Respiratory Testing: A Prospective Observational Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Infant, Newborn, Diseases, Bronchopulmonary Dysplasia, Respiratory Distress Syndrome, Newborn, Meconium Aspiration Syndrome, Transient Tachypnea of the Newborn

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This will be a single center prospective observational study with pre-specified Aims and Hypotheses
Masking
None (Open Label)
Allocation
N/A
Enrollment
1098 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive forced airway oscillometry
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Non-invasive forced airway oscillometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Area under the reactance curve (AXR)
Description
AXR as an overall measure of reactance quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Secondary Outcome Measure Information:
Title
R7-20
Description
Difference between resistance at 7 Hz and 20 Hz quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
R7
Description
Resistance at 7 Hz quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
X7
Description
Reactance at 7 Hz quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
R11
Description
Resistance at 11 Hz quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
R19
Description
Resistance at 19 Hz quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
X11
Description
Reactance at 11 Hz quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
X19
Description
Reactance at 19 Hz quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
Impedance R(f)
Description
Resistance as a function of frequency R(f) quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
Impedance x(f)
Description
Reactance as a function of frequency x(f) quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
Resonance frequency
Description
Resonance frequency quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
Tidal volume
Description
Tidal volume measured in mL/kg quantified by oscillometry
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
Respiratory rate
Description
Respiratory rate in breaths per minute
Time Frame
40 weeks' postmenstrual age or discharge until 2 years
Title
Longer-term pulmonary outcomes
Description
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)
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colm P Travers, MD
Phone
205 9344680
Email
ctravers@peds.uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tara McNair, RN
Phone
2059344680
Email
tmcnair@peds.uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Namasivayam Ambalavanan, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colm P Travers, MD
Phone
205-934-4680
Email
ctravers@peds.uab.edu
First Name & Middle Initial & Last Name & Degree
Tara E McNair, RN
Phone
205 923 4680
Email
temcnair@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31935746
Citation
Klinger AP, Travers CP, Martin A, Kuo HC, Alishlash AS, Harris WT, Carlo WA, Ambalavanan N. Non-invasive forced oscillometry to quantify respiratory mechanics in term neonates. Pediatr Res. 2020 Aug;88(2):293-299. doi: 10.1038/s41390-020-0751-7. Epub 2020 Jan 14.
Results Reference
derived

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Pulmonary Function Using Non-invasive Forced Oscillometry

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