Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Ulm

Criteria

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