Trial Outcomes & Findings for Pulmonary Function Using Non-invasive Forced Oscillometry (NCT NCT03346343)
NCT ID: NCT03346343
Last Updated: 2026-01-27
Results Overview
AXR as the measure of overall measure of reactance of the respiratory system quantified by oscillometry and measured in cmH2O/L
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
600 participants
Primary outcome timeframe
40 weeks' postmenstrual age or discharge until 2 years
Results posted on
2026-01-27
Participant Flow
Participant milestones
| Measure |
Bronchopulmonary Dysplasia at 36 Weeks
Infants with a diagnosis of bronchopulmonary dysplasia based on respiratory support at 36 weeks' postmenstrual age
|
Infant Respiratory Distress Syndrome
Infants with a diagnosis of respiratory distress syndrome based on initial requirement for respiratory support but who did not meet criteria for BPD
|
Preterm no RDS/BPD
Preterm infants with no RDS or BPD
|
Control
Term/Late Preterm infants with no respiratory disease
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
133
|
228
|
94
|
145
|
|
Overall Study
COMPLETED
|
133
|
228
|
94
|
145
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pulmonary Function Using Non-invasive Forced Oscillometry
Baseline characteristics by cohort
| Measure |
Bronchopulmonary Dysplasia at 36 Weeks
n=133 Participants
Infants with a diagnosis of bronchopulmonary dysplasia based on respiratory support at 36 weeks' postmenstrual age
|
Infant Respiratory Distress Syndrome
n=228 Participants
Infants with a diagnosis of respiratory distress syndrome based on initial requirement for respiratory support but who did not meet criteria for BPD
|
Preterm no RDS/BPD
n=94 Participants
Preterm infants with no RDS or BPD
|
Control
n=145 Participants
Term/Late Preterm infants with no respiratory disease
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
133 Participants
n=25 Participants
|
228 Participants
n=25 Participants
|
94 Participants
n=50 Participants
|
145 Participants
n=152 Participants
|
600 Participants
n=614 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=25 Participants
|
121 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
72 Participants
n=152 Participants
|
311 Participants
n=614 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=25 Participants
|
107 Participants
n=25 Participants
|
44 Participants
n=50 Participants
|
73 Participants
n=152 Participants
|
289 Participants
n=614 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
6 Participants
n=152 Participants
|
15 Participants
n=614 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=25 Participants
|
90 Participants
n=25 Participants
|
42 Participants
n=50 Participants
|
46 Participants
n=152 Participants
|
255 Participants
n=614 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=25 Participants
|
133 Participants
n=25 Participants
|
48 Participants
n=50 Participants
|
93 Participants
n=152 Participants
|
330 Participants
n=614 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=25 Participants
|
10 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
5 Participants
n=152 Participants
|
24 Participants
n=614 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=25 Participants
|
218 Participants
n=25 Participants
|
91 Participants
n=50 Participants
|
140 Participants
n=152 Participants
|
576 Participants
n=614 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
|
Gestational Age
|
25 weeks
STANDARD_DEVIATION 2 • n=25 Participants
|
29 weeks
STANDARD_DEVIATION 3 • n=25 Participants
|
33 weeks
STANDARD_DEVIATION 2 • n=50 Participants
|
38 weeks
STANDARD_DEVIATION 1 • n=152 Participants
|
31 weeks
STANDARD_DEVIATION 2 • n=614 Participants
|
PRIMARY outcome
Timeframe: 40 weeks' postmenstrual age or discharge until 2 yearsAXR as the measure of overall measure of reactance of the respiratory system quantified by oscillometry and measured in cmH2O/L
Outcome measures
| Measure |
Bronchopulmonary Dysplasia at 36 Weeks
n=123 Participants
Infants with a diagnosis of bronchopulmonary dysplasia based on respiratory support at 36 weeks' postmenstrual age
|
Infant Respiratory Distress Syndrome
n=221 Participants
Infants with a diagnosis of respiratory distress syndrome based on initial requirement for respiratory support but who did not meet criteria for BPD
|
Preterm no RDS/BPD
n=93 Participants
Preterm infants with no RDS or BPD
|
Control
n=145 Participants
Term/Late Preterm infants with no respiratory disease
|
|---|---|---|---|---|
|
Area Under the Reactance Curve (AXR)
|
733 cmH2O/L
Standard Deviation 257
|
599 cmH2O/L
Standard Deviation 212
|
495 cmH2O/L
Standard Deviation 159
|
385 cmH2O/L
Standard Deviation 198
|
SECONDARY outcome
Timeframe: 40 weeks' postmenstrual age or discharge until 2 yearsDifference between resistance at 7 Hz and 20 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
Outcome measures
| Measure |
Bronchopulmonary Dysplasia at 36 Weeks
n=123 Participants
Infants with a diagnosis of bronchopulmonary dysplasia based on respiratory support at 36 weeks' postmenstrual age
|
Infant Respiratory Distress Syndrome
n=221 Participants
Infants with a diagnosis of respiratory distress syndrome based on initial requirement for respiratory support but who did not meet criteria for BPD
|
Preterm no RDS/BPD
n=93 Participants
Preterm infants with no RDS or BPD
|
Control
n=145 Participants
Term/Late Preterm infants with no respiratory disease
|
|---|---|---|---|---|
|
R7-20
|
24 cmH2O·s/L
Standard Deviation 10
|
20 cmH2O·s/L
Standard Deviation 8
|
17 cmH2O·s/L
Standard Deviation 6
|
13 cmH2O·s/L
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 40 weeks' postmenstrual age or discharge until 2 yearsResistance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
Outcome measures
| Measure |
Bronchopulmonary Dysplasia at 36 Weeks
n=123 Participants
Infants with a diagnosis of bronchopulmonary dysplasia based on respiratory support at 36 weeks' postmenstrual age
|
Infant Respiratory Distress Syndrome
n=221 Participants
Infants with a diagnosis of respiratory distress syndrome based on initial requirement for respiratory support but who did not meet criteria for BPD
|
Preterm no RDS/BPD
n=93 Participants
Preterm infants with no RDS or BPD
|
Control
n=145 Participants
Term/Late Preterm infants with no respiratory disease
|
|---|---|---|---|---|
|
R7
|
56 cmH2O·s/L
Standard Deviation 16
|
51 cmH2O·s/L
Standard Deviation 13
|
46 cmH2O·s/L
Standard Deviation 9
|
40 cmH2O·s/L
Standard Deviation 13
|
SECONDARY outcome
Timeframe: 40 weeks' postmenstrual age or discharge until 2 yearsReactance at 7 Hz in the respiratory system quantified by oscillometry and measured in cmH2O·s/L
Outcome measures
| Measure |
Bronchopulmonary Dysplasia at 36 Weeks
n=123 Participants
Infants with a diagnosis of bronchopulmonary dysplasia based on respiratory support at 36 weeks' postmenstrual age
|
Infant Respiratory Distress Syndrome
n=221 Participants
Infants with a diagnosis of respiratory distress syndrome based on initial requirement for respiratory support but who did not meet criteria for BPD
|
Preterm no RDS/BPD
n=93 Participants
Preterm infants with no RDS or BPD
|
Control
n=145 Participants
Term/Late Preterm infants with no respiratory disease
|
|---|---|---|---|---|
|
X7
|
-53 cmH2O·s/L
Standard Deviation 21
|
-45 cmH2O·s/L
Standard Deviation 16
|
-39 cmH2O·s/L
Standard Deviation 10
|
-34 cmH2O·s/L
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Up to 2 yearsSevere 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)
Outcome measures
Outcome data not reported
Adverse Events
Bronchopulmonary Dysplasia at 36 Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Infant Respiratory Distress Syndrome
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Preterm no RDS/BPD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place