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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cardio-Pulmonary-Exercise-Testing (CPET)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Term

    Late preterms

    Preterms with BPD

    pretermas without BPD

    Arm Description

    7-10 years old born at 37-42 weeks gestation

    7-10 years old born at 34.0-36.6 weeks gestation

    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

    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)

    Outcomes

    Primary Outcome Measures

    The peak oxygen consumption (VO2max)
    The peak oxygen consumption (VO2max)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2021
    Last Updated
    April 7, 2021
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04833647
    Brief Title
    Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
    Official Title
    Influence of Prematurity and Its Respiratory Sequel on Exercise Testing in Childhood
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2016 (Actual)
    Primary Completion Date
    August 1, 2020 (Actual)
    Study Completion Date
    February 1, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    The Peak Oxygen Consumption (VO2max) Was Measured and Served as the Primary Endpoint of the Study

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Term
    Arm Type
    Other
    Arm Description
    7-10 years old born at 37-42 weeks gestation
    Arm Title
    Late preterms
    Arm Type
    Other
    Arm Description
    7-10 years old born at 34.0-36.6 weeks gestation
    Arm Title
    Preterms with BPD
    Arm Type
    Other
    Arm Description
    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
    Arm Title
    pretermas without BPD
    Arm Type
    Other
    Arm Description
    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)
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Cardio-Pulmonary-Exercise-Testing (CPET)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    The peak oxygen consumption (VO2max)
    Description
    The peak oxygen consumption (VO2max)
    Time Frame
    During the 1 day test

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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