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Completed

NCT Number: NCT04833647

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

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

Completed

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Key information

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cardio-Pulmonary-Exercise-Testing (CPET)

Diagnostic Test

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

Primary outcomes

  1. The peak oxygen consumption (VO2max)

    Time frame: During the 1 day test

    The peak oxygen consumption (VO2max)

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Apr 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.