Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

Study Overview
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Brief Summary
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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%.

Official Title
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Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

Conditions
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Intermittent Hypoxemia, Apnea of Prematurity

Intervention / Treatment
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* Drug: Oxygen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Days
Maximum Age: 42 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low target range<br>Low oxygen saturation target range: SpO2 85-89% | Drug: Oxygen<br>* Adapt inspired oxygen to achieve desired SpO2 target range<br>|
| Active Comparator: High target range<br>High oxygen saturation target range: SpO2 91-95% | Drug: Oxygen<br>* Adapt inspired oxygen to achieve desired SpO2 target range<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration SpO2 < 80% |  | during 16 hours of measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral tissue oxygen saturation as measured by NIRS | Area under threshold | during 16 hours of measurement | 
| Arterial SpO2 as measured by pulse oxymetry | Area under 80% | during 16 hours of measurement | 
| Heart rate as measured by ECG | Area under 80/min | during 16 hours of measurement | 
| cerebral and visceral fractional oxygen extraction as measured by NIRS |  | during 16 hours of measurement | 
| Cardiac output as measured by Cardiovelocimetry |  | during 16 hours of measurement | 
| Number of hypoxemic and / or bradycardic events |  | during 16 hours of measurement | 
| Visceral tissue oxygen saturation as measured by NIRS | Area under threshold | during 16 hours of measurement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral oxygenation, NIRS, near-infrared spectroscopy, bradycardia, hypoxemia, cerebral perfusion, cardiac output, apnea, desaturation, oxygen saturation target range