Hypoxia Intolerance in Preterm Individuals (PreAlti)

Jozef Stefan Institute

Status: Completed

Conditions: Hypoxia; Premature Birth

Treatments: Other: Normoxia; Other: Hypobaric hypoxia; Other: Normobaric hypoxia

Study type: Observational

Funder types: Other

Identifiers

NCT04739904

PreAlti

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• prematurely born (gestational age: ≤ 32 weeks; gestational weight ≤ 1500g)
• full-term born
• healthy individuals
• male

Exclusion criteria

• presence of any medical risk factors to exercise and/or exposure to altitude
• presence of any medical condition that would make the protocol unreasonably hazardous for the patient
• smokers
• exposure to altitude above 1000m in the last 2 months

Trial design

36 participants in 2 patient groups

Preterm born

Description:

Premature born but otherwise healthy adults exposed to normoxic, normobaric hypoxic and hypobaric hypoxic interventions.

Treatment:

Other: Normobaric hypoxia

Other: Hypobaric hypoxia

Other: Normoxia

Full-term control

Description:

Full-term born healthy adults exposed to normoxic, normobaric hypoxic and hypobaric hypoxic interventions.

Treatment:

Other: Normobaric hypoxia

Other: Hypobaric hypoxia

Other: Normoxia