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

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

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833647
• Other study ID #: 0239-14-RMB
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: February 1, 2021

Study information

• Verified date: April 2021
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 10 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The peak oxygen consumption (VO2max)	The peak oxygen consumption (VO2max)	During the 1 day test