Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 83
- Primary Endpoint
- The peak oxygen consumption (VO2max)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 10 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •7-10 years of age
- •The ability to ride stationary bicycles as assessed by the parents.
Exclusion Criteria
- •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).
Arms & Interventions
Term
7-10 years old born at 37-42 weeks gestation
Intervention: Cardio-Pulmonary-Exercise-Testing (CPET) (Diagnostic Test)
Late preterms
7-10 years old born at 34.0-36.6 weeks gestation
Intervention: Cardio-Pulmonary-Exercise-Testing (CPET) (Diagnostic Test)
Preterms with BPD
7-10 years old born before 30 weeks gestation with the diagnosis of BPD: the need for oxygen at 36 weeks gestation and/or flow or 3LPM or more, and/or the need for CPAP or invasive ventilation
Intervention: Cardio-Pulmonary-Exercise-Testing (CPET) (Diagnostic Test)
pretermas without BPD
7-10 years old born before 30 weeks gestation without the diagnosis of BPD (without the need for oxygen at 36 weeks gestation and/or flow or 3LPM or more, and/or the need for CPAP or invasive ventilation)
Intervention: Cardio-Pulmonary-Exercise-Testing (CPET) (Diagnostic Test)
Outcomes
Primary Outcomes
The peak oxygen consumption (VO2max)
Time Frame: During the 1 day test
The peak oxygen consumption (VO2max)
Secondary Outcomes
No secondary outcomes reported
Investigators
Ori Hochwald , MD
Director, NICU
Rambam Health Care Campus