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NCT Number: NCT03346343

Pulmonary Function Using Non-invasive Forced Oscillometry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Infant, Premature, Diseases Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Infant, Newborn, Diseases Lung Diseases Lung Injury Meconium Aspiration Syndrome Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachypnea Transient Tachypnea of the Newborn Urogenital Diseases Ventilator-Induced Lung Injury

Age range

1 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Non-invasive forced airway oscillometry

Device

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 outcomes

  1. Area Under the Reactance Curve (AXR)

    Time frame: 40 weeks' postmenstrual age or discharge until 2 years

    AXR as the measure of overall measure of reactance of the respiratory system quantified by oscillometry and measured in cmH2O/L

Secondary outcomes

  1. R7-20

    Time frame: 40 weeks' postmenstrual age or discharge until 2 years

    Difference between resistance at 7 Hz and 20 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L

  2. R7

    Time frame: 40 weeks' postmenstrual age or discharge until 2 years

    Resistance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L

  3. X7

    Time frame: 40 weeks' postmenstrual age or discharge until 2 years

    Reactance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L

  4. Longer-term Pulmonary Outcomes

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: PUFFOR

Important dates

Study start
2017
Primary completion
2024
Study completion
2027
First posted
Nov 17, 2017
Registry last updated
Jan 27, 2026

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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