CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Normoxia +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04739904
NCT04739904N/ACompleted

Mechanisms of Hypoxia (in)Tolerance in Prematurely Born Individuals

Jozef Stefan Institute·observational·Posted Feb 5, 2021·Updated Aug 15, 2024

In Brief

An observational study evaluating Normoxia, Normobaric hypoxia, and 1 other intervention for Premature Birth and Hypoxia. Completed, enrolled 36 participants across 3 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSlovenia, Switzerland

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 5, 2021
Enrollment StartApr 30, 2021
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.4 years ago

Interventions

Normoxiaother

48 hours experimental protocol conducted at sea level

Normobaric hypoxiaother

24 hours experimental protocol conducted in a normobaric hypoxic facility

Hypobaric hypoxiaother

72 hours experimental protocol conducted at terrestrial altitude