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

Rambam Health Care Campus0 sites83 target enrollmentApril 1, 2016

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

Overview

Phase: N/A
Intervention: Not specified
Conditions: The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
Sponsor: Rambam Health Care Campus
Enrollment: 83
Primary Endpoint: The peak oxygen consumption (VO2max)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2016

End Date

February 1, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rambam Health Care Campus

Responsible Party

Principal Investigator

Ori Hochwald , MD

Director, NICU

Rambam Health Care Campus

Eligibility Criteria

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).