An interventional study of Non-invasive forced airway oscillometry in Infant, Premature, Diseases, Infant, Newborn, Diseases and Bronchopulmonary Dysplasia, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to participants aged 1 Day to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Diagnostic
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.
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.
88 studies on the registry are indexed under Infant, Premature, Diseases; 12 are open to participants now.
This study's enrollment of 600 is above the median of 63 across 57 interventional studies indexed under Infant, Premature, Diseases.
Browse Infant, Premature, Diseases studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
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.
Area Under the Reactance Curve (AXR)
AXR as the measure of overall measure of reactance of the respiratory system quantified by oscillometry and measured in cmH2O/L
Time frame: 40 weeks' postmenstrual age or discharge until 2 years
R7-20
Difference between resistance at 7 Hz and 20 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
Time frame: 40 weeks' postmenstrual age or discharge until 2 years
R7
Resistance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
Time frame: 40 weeks' postmenstrual age or discharge until 2 years
X7
Reactance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
Time frame: 40 weeks' postmenstrual age or discharge until 2 years
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)
Time frame: Up to 2 years
| Milestone | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control |
|---|---|---|---|---|
| Started | 133 | 228 | 94 | 145 |
| Completed | 133 | 228 | 94 | 145 |
| Not completed | 0 | 0 | 0 | 0 |
AXR as the measure of overall measure of reactance of the respiratory system quantified by oscillometry and measured in cmH2O/L
| cmH2O/L | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control |
|---|---|---|---|---|
| Area Under the Reactance Curve (AXR) | 733 ± 257 | 599 ± 212 | 495 ± 159 | 385 ± 198 |
Difference between resistance at 7 Hz and 20 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
| cmH2O·s/L | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control |
|---|---|---|---|---|
| R7-20 | 24 ± 10 | 20 ± 8 | 17 ± 6 | 13 ± 9 |
Resistance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
| cmH2O·s/L | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control |
|---|---|---|---|---|
| R7 | 56 ± 16 | 51 ± 13 | 46 ± 9 | 40 ± 13 |
Reactance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
| cmH2O·s/L | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control |
|---|---|---|---|---|
| X7 | -53 ± 21 | -45 ± 16 | -39 ± 10 | -34 ± 13 |
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)
Results for this outcome have not been posted.
Collected over During oscillometry testing from beginning of test until completion of test up to 30 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bronchopulmonary Dysplasia at 36 Weeks | 0/133 (0%) | 0/133 (0%) | 0/133 (0%) |
| Infant Respiratory Distress Syndrome | 0/228 (0%) | 0/228 (0%) | 0/228 (0%) |
| Preterm no RDS/BPD | 0/94 (0%) | 0/94 (0%) | 0/94 (0%) |
| Control | 0/145 (0%) | 0/145 (0%) | 0/145 (0%) |
| Age, Categorical(Participants) | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control | Total |
|---|---|---|---|---|---|
| <=18 years | 133 | 228 | 94 | 145 | 600 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control | Total |
|---|---|---|---|---|---|
| Female | 68 | 121 | 50 | 72 | 311 |
| Male | 65 | 107 | 44 | 73 | 289 |
| Race (NIH/OMB)(Participants) | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 5 | 4 | 6 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 77 | 90 | 42 | 46 | 255 |
| White | 56 | 133 | 48 | 93 | 330 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 6 | 10 | 3 | 5 | 24 |
| Not Hispanic or Latino | 127 | 218 | 91 | 140 | 576 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Gestational Age(weeks) | Bronchopulmonary Dysplasia at 36 Weeks | Infant Respiratory Distress Syndrome | Preterm no RDS/BPD | Control | Total |
|---|---|---|---|---|---|
| Mean | 25 ± 2 | 29 ± 3 | 33 ± 2 | 38 ± 1 | 31 ± 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Oct 2024, 82 months.
Results were first posted in Jan 2026, 1 year 3 months after primary completion.
Of 33 non-industry interventional studies with no phase under Infant, Premature, Diseases, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's 82 months is above that.
Counting every sponsor, half of 33 studies reached it within 19 months; a quarter within 11 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →