Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

Not Applicable

• Conditions: Intermittent Hypoxemia; Apnea of Prematurity
• Interventions: Drug: Oxygen

• Registration Number: NCT02743988
• Lead Sponsor: University of Ulm

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-04
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-14
• Last Update Submitted: 2016-04-14
• Study First Posted: 2016-04-19
• Last Update Posted: 2016-04-19
• Primary Completion: 2017-04
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High target range	Oxygen	High oxygen saturation target range: SpO2 91-95%
Low target range	Oxygen	Low oxygen saturation target range: SpO2 85-89%

Primary Outcome Measures

Name	Time	Method
Duration SpO2 < 80%	during 16 hours of measurement

Secondary Outcome Measures

Name	Time	Method
Cerebral tissue oxygen saturation as measured by NIRS	during 16 hours of measurement	Area under threshold
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
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	during 16 hours of measurement	Area under threshold

Trial Locations

Locations (1)

University Medical Center, Ulm University; 🇩🇪 Ulm, Baden-Württemberg, Germany