Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
NCT ID: NCT04833647
Last Updated: 2021-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2016-04-01
2021-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Term
7-10 years old born at 37-42 weeks gestation
Cardio-Pulmonary-Exercise-Testing (CPET)
Cardio-Pulmonary-Exercise-Testing (CPET) . 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
Late preterms
7-10 years old born at 34.0-36.6 weeks gestation
Cardio-Pulmonary-Exercise-Testing (CPET)
Cardio-Pulmonary-Exercise-Testing (CPET) . 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
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
Cardio-Pulmonary-Exercise-Testing (CPET)
Cardio-Pulmonary-Exercise-Testing (CPET) . 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
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)
Cardio-Pulmonary-Exercise-Testing (CPET)
Cardio-Pulmonary-Exercise-Testing (CPET) . 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
Interventions
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Cardio-Pulmonary-Exercise-Testing (CPET)
Cardio-Pulmonary-Exercise-Testing (CPET) . 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
Eligibility Criteria
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Inclusion Criteria
* The ability to ride stationary bicycles as assessed by the parents.
Exclusion Criteria
* 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).
7 Years
10 Years
ALL
Yes
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Ori Hochwald , MD
Director, NICU
Other Identifiers
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0239-14-RMB
Identifier Type: -
Identifier Source: org_study_id
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