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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833647
Enrollment
83
Registered
2021-04-06
Start date
2016-04-01
Completion date
2021-02-01
Last updated
2021-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTCardio-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

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
The peak oxygen consumption (VO2max)During the 1 day testThe peak oxygen consumption (VO2max)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026