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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 1, 2020

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 Test: 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

Arms, Groups and Cohorts

  • Other: Term
    • 7-10 years old born at 37-42 weeks gestation
  • Other: Late preterms
    • 7-10 years old born at 34.0-36.6 weeks gestation
  • Other: 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
  • Other: 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)

Clinical Trial Outcome Measures

Primary Measures

  • The peak oxygen consumption (VO2max)
    • Time Frame: During the 1 day test
    • The peak oxygen consumption (VO2max)

Participating in This Clinical Trial

Inclusion Criteria

7-10 years of age and the ability to ride stationary bicycles as assessed by the parents. Exclusion Criteria:

included 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) and a congenital cardiac defect (with the exception of atrial septal defect and patent foramen ovale).

Gender Eligibility: All

Minimum Age: 7 Years

Maximum Age: 10 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rambam Health Care Campus
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ori Hochwald , MD, MD – Rambam Health Care Campus

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