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

Rambam Health Care Campus

Status: Completed

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

Treatments: Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)

Study type: Interventional

Funder types: Other

Identifiers

NCT04833647

0239-14-RMB

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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83 participants in 4 patient groups

Term

Other group

Description:

7-10 years old born at 37-42 weeks gestation

Treatment:

Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)

Late preterms

Other group

Description:

7-10 years old born at 34.0-36.6 weeks gestation

Treatment:

Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)

Preterms with BPD

Other group

Description:

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

Treatment:

Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)

pretermas without BPD

Other group

Description:

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)

Treatment:

Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)