Clinical Trials Directory

Trials / Completed

CompletedNCT04739904

Hypoxia Intolerance in Preterm Individuals

Mechanisms of Hypoxia (in)Tolerance in Prematurely Born Individuals

Status
Completed
Phase
Study type
Observational
Enrollment
36 (actual)
Sponsor
Jozef Stefan Institute · Academic / Other
Sex
Male
Age
18 Years – 30 Years
Healthy volunteers
Accepted

Summary

Reduced Hypoxic Ventilatory Response (HVR) and systemic O2 saturation subsequently leading to blunted aerobic capacity as well as decreased overall physical and cognitive performance are the main physiological challenges faced by prematurely born individuals in hypobaric hypoxia (i.e. during high altitude sojourn). While these phenomena have been described previously, the underlying mechanisms are currently unresolved. Given that the reduction in altitude-performance and its underlying mechanisms are not well understood, it is currently impossible to give evidence-based recommendation for altitude sojourns in this cohort. It is also of note, that even hypobaric hypoxia exposure during long-haul flights might be detrimental to well-being of pre-term born individuals. The present project aims to comprehensively investigate physiological responses to altitude/hypoxia during rest and exercise in prematurely born, but otherwise healthy adults. Specifically, the investigators aim to elucidate the underlying mechanisms of the altered resting and exercise cardiovascular, respiratory, cerebral and hematological responses to hypoxia in prematurely born individuals. The obtained results from this cohort will be compared to the data from a control groups consisting of healthy, age and aerobic capacity-matched individuals born at full-term. While acute hypoxic effects will be the focus of the project's first phase, the researchers will test the effect of prolonged terrestrial (real) or simulated (normobaric hypoxia) altitude exposures in the second part. This phase will, in addition to the insight into the prolonged altitude acclimatization modulation in prematurely born individuals, also enable the potential differences between the effects of normobaric (simulated) and hypobaric (terrestrial) hypoxia in this cohort to be investigated.

Conditions

Interventions

TypeNameDescription
OTHERNormoxia48 hours experimental protocol conducted at sea level
OTHERNormobaric hypoxia24 hours experimental protocol conducted in a normobaric hypoxic facility
OTHERHypobaric hypoxia72 hours experimental protocol conducted at terrestrial altitude

Timeline

Start date
2021-04-30
Primary completion
2022-03-31
Completion
2022-03-31
First posted
2021-02-05
Last updated
2024-08-15

Locations

3 sites across 2 countries: Slovenia, Switzerland

Source: ClinicalTrials.gov record NCT04739904. Inclusion in this directory is not an endorsement.