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

Study Overview

• Status: Completed
• Conditions: The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
• Intervention / Treatment: Diagnostic test: Cardio-Pulmonary-Exercise-Testing (CPET)

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Term; 7-10 years old born at 37-42 weeks gestation	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
Other: Late preterms; 7-10 years old born at 34.0-36.6 weeks gestation	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
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	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
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)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The peak oxygen consumption (VO2max)	The peak oxygen consumption (VO2max)	During the 1 day test

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: April 3, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 0239-14-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No