Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood

Conditions
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The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study

Intervention / Treatment
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* Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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. A CPET technician and a senior pediatrician were present and monitored the participants' condition during the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Term<br>7-10 years old born at 37-42 weeks gestation | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)<br>* 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<br>|
| Other: Late preterms<br>7-10 years old born at 34.0-36.6 weeks gestation | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)<br>* 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<br>|
| Other: Preterms with BPD<br>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 | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)<br>* 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<br>|
| Other: pretermas without BPD<br>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) | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The peak oxygen consumption (VO2max) | The peak oxygen consumption (VO2max) | During the 1 day test |