Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
- Conditions
- The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
- Registration Number
- NCT04833647
- Lead Sponsor
- Rambam Health Care Campus
- Brief Summary
Prospective study comparing hemodynamic and respiratory changes and exercise capacity during Cardio-Pulmonary-Exercise-Testing (CPET) in 4 groups of infants; Three different groups of premature infants and term controls
- Detailed Description
The study population included 4 groups of infants; preterm infants born \< 300 weeks' gestation with BPD (i.e. oxygen dependence for at least 28 postnatal days 5), preterm infants born \< 300 weeks' gestation without BPD, late preterm infants (born at 340-366 weeks' gestation) and term controls.
Pulmonary function testing and spirometry were measured Participants performed CPET on an electronically braked cycle ergometer. During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained.
The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 7-10 years of age
- The ability to ride stationary bicycles as assessed by the parents.
- Immobility
- An acute febrile or upper respiratory illness in the last 2 weeks
- The use systemic or inhaled steroids or antiepileptic drugs in the previous month
- Inhaled bronchodilator use in the previous 24 hours
- A chronic lung illness (with the exception of BPD and asthma)
- Congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The peak oxygen consumption (VO2max) During the 1 day test The peak oxygen consumption (VO2max)
- Secondary Outcome Measures
Name Time Method