Pulmonary Function Using Non-invasive Forced Oscillometry

Bronchopulmonary Dysplasia Clinical Trial

— PUFFOR  

Official title:

Pulmonary Function Using Non-invasive Forced Oscillometry Respiratory Testing: A Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03346343
• Other study ID #: IRB-300000296
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Colm P Travers, MD
• Phone: 205 9344680
• Email: ctravers[@]peds.uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1098
• Est. completion date: May 2027
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Infant, Newborn, Diseases
• Infant, Premature, Diseases
• Meconium Aspiration Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome
• Tachypnea
• Transient Tachypnea of the Newborn

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the reactance curve (AXR)	AXR as an overall measure of reactance quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	R7-20	Difference between resistance at 7 Hz and 20 Hz quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	R7	Resistance at 7 Hz quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	X7	Reactance at 7 Hz quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	R11	Resistance at 11 Hz quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	R19	Resistance at 19 Hz quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	X11	Reactance at 11 Hz quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	X19	Reactance at 19 Hz quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	Impedance R(f)	Resistance as a function of frequency R(f) quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	Impedance x(f)	Reactance as a function of frequency x(f) quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	Resonance frequency	Resonance frequency quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	Tidal volume	Tidal volume measured in mL/kg quantified by oscillometry	40 weeks' postmenstrual age or discharge until 2 years
Secondary	Respiratory rate	Respiratory rate in breaths per minute	40 weeks' postmenstrual age or discharge until 2 years
Secondary	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)	Up to 2 years