The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the StudyNCT04833647
Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
A study testing Cardio-Pulmonary-Exercise-Testing (CPET) in people with The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study, run by Rambam Health Care Campus.
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 Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
- What is being tested?
- Cardio-Pulmonary-Exercise-Testing (CPET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7-10 years of age
- The ability to ride stationary bicycles as assessed by the parents.
Who cannot join
- 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).
About this study
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
Read the 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.
- Conditions
- The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
- Being tested
- Cardio-Pulmonary-Exercise-Testing (CPET)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Term | Other | 7-10 years old born at 37-42 weeks gestation Receives: Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) |
| Late preterms | Other | 7-10 years old born at 34.0-36.6 weeks gestation Receives: Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) |
| Preterms with BPD | Other | 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 Receives: Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) |
| pretermas without BPD | Other | 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) Receives: Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak oxygen consumption (VO2max)
The peak oxygen consumption (VO2max)
Measured: During the 1 day test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Apr 2016
- Primary completion1 Aug 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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. A CPET technician and a senior pediatrician were present and monitored the participants' condition during the study.
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Hochwald , MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833647
- Sponsor's protocol ID
- 0239-14-RMB
- Status last verified
- Apr 2021
- First submitted
- 3 Apr 2021
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zlotnik S, Bar-Yoseph R, Nasser K, Hochwald O. Daily participation in preterm-born children: An exploratory and comparative study. Early Hum Dev. 2025 Feb;201:106200. doi: 10.1016/j.earlhumdev.2025.106200. Epub 2025 Jan 15.
PubMed 39826158
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
- ClinicalTrials.gov ID
- NCT04833647
- Acronym / sponsor ID
- 0239-14-RMB
- Conditions
- The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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. A CPET technician and a senior pediatrician were present and monitored the participants' condition during the study.
| Arm | Type | Receives |
|---|---|---|
| Term | Other | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)7-10 years old born at 37-42 weeks gestation |
| Late preterms | Other | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)7-10 years old born at 34.0-36.6 weeks gestation |
| Preterms with BPD | Other | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)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 |
| pretermas without BPD | Other | Diagnostic Test: Cardio-Pulmonary-Exercise-Testing (CPET)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) |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 7-10 years of age
- The ability to ride stationary bicycles as assessed by the parents.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Late preterms, Preterms with BPD, Term, pretermas without BPD |
Primary outcome
The peak oxygen consumption (VO2max)
Time frame: During the 1 day test
The peak oxygen consumption (VO2max)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Derived from this study: PubMed 39826158Zlotnik S, Bar-Yoseph R, Nasser K, Hochwald O. Daily participation in preterm-born children: An exploratory and comparative study. Early Hum Dev. 2025 Feb;201:106200. doi: 10.1016/j.earlhumdev.2025.106200. Epub 2025 Jan 15.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cardio-Pulmonary-Exercise-Testing (CPET) in people with The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak oxygen consumption (VO2max) (time frame: During the 1 day test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.