Apnea of Prematurity, Intermittent Hypoxemia
Conditions
Keywords
cerebral oxygenation, NIRS, near-infrared spectroscopy, bradycardia, hypoxemia, cerebral perfusion, cardiac output, apnea, desaturation, oxygen saturation target range
Brief summary
In this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either Sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. Cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. Primary outcome is time with arterial oxygen saturation \< 80%.
Interventions
DRUGOxygen
Adapt inspired oxygen to achieve desired SpO2 target range
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Days to 42 Days
Healthy volunteers
No
Inclusion criteria
* preterm infant \< 29 weeks gestation * at least 8 hypoxemic events during 8 hours * requires supplemental oxygen to achieve high SpO2 target range * parental consent given
Exclusion criteria
* congenital life-threatening malformation * fatal outcome expected * airway malformation * higher grade intraventricular bleeding (grade III or IV according to LA Papile) * posthaemorrhagic hydrocephalus * life-threatening disease at the time of study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration SpO2 < 80% | during 16 hours of measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial SpO2 as measured by pulse oxymetry | during 16 hours of measurement | Area under 80% |
| Heart rate as measured by ECG | during 16 hours of measurement | Area under 80/min |
| cerebral and visceral fractional oxygen extraction as measured by NIRS | during 16 hours of measurement | — |
| Cerebral tissue oxygen saturation as measured by NIRS | during 16 hours of measurement | Area under threshold |
| Number of hypoxemic and / or bradycardic events | during 16 hours of measurement | — |
| Visceral tissue oxygen saturation as measured by NIRS | during 16 hours of measurement | Area under threshold |
| Cardiac output as measured by Cardiovelocimetry | during 16 hours of measurement | — |
Countries
Germany
Contacts
Primary ContactManuel B Schmid, MD
Outcome results
None listed