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This project will consist of two studies, each investigating resting and exercise cardio-respiratory responses during exposure to hypoxia in individuals born prematurely and individuals born at full term of two different age groups: Kids (10-14 yrs) and Adults (18-22 yrs).Additional study will be performed on a preterm adult cohort (15 participants) that will investigate potential differences between hypobaric and normobaric hypoxia as outlined in the following section.
Full description
The study protocol in each age group will comprise two visits to the laboratory testing sessions in a randomized order. On one occasion the participants will perform a resting hypoxia test and a graded exercise test to voluntary exhaustion in normoxic condition ((NORM; fraction of inspired oxygen (FiO2)=0.209, placebo). On a second visit the participants will perform a hypoxia sensitivity test and a graded exercise test to voluntary exhaustion in hypoxic condition (HYPO; FiO2=0.120 corresponding to terrestrial altitude of approx. 4000 m). Indirect calorimetry, near infrared spectroscopy and ECG measurements will be performed throughout all tests. During both testing sessions the participants will also undergo anthropometry measurements and pulmonary function testing. The outline of the research visits is presented in the bellow figure:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Healthy male individuals
PRETERM group; gestational age: ≤ 32 weeks; gestational weight ≤ 1500 g
CONTROL group: full term born individuals ≤ 38 weeks
Exclusion criteria
Medication required that may interfere with the interpretation of the results
Chronically illnesses
Hormonal therapy
Recent sub-standard nutritional status
Family history of respiratiory, cardio-vascular, renal or hematological disease History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcaemia, uric acidaemia, lipidaemia or hyperhomocystinaemia
History of mental illness
Smoker within six months prior to the start of the study
Abuse of drugs, medicine or alcohol
Participation in another study up to two months before study onset
No signed consent form before the onset of the experiment
Blood donors in the past three months before the onset of the experiment
Vegetarian and Vegans
Migraines
History of vestibular disorders
Claustrophobia
Primary purpose
Allocation
Interventional model
Masking
37 participants in 2 patient groups, including a placebo group
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Central trial contact
Tadej Debevec, PhD; Damjan Osredkar, MD, PhD
Data sourced from clinicaltrials.gov
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