Pulmonary Function Using Non-invasive Forced Oscillometry Respiratory Testing: A Prospective Observational Study
Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 2
Healthy Volunteers: t
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Time Frame
Start Date: 2017-12-06
Completion Date: 2027-05
Participants
Target number of participants: 1098
Treatments
Experimental: Non-invasive forced airway oscillometry
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
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham