Back to resultsInfluence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
Primary Purpose
Intermittent Hypoxemia, Apnea of Prematurity
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Hypoxemia focused on measuring cerebral oxygenation, NIRS, near-infrared spectroscopy, bradycardia, hypoxemia, cerebral perfusion, cardiac output, apnea, desaturation, oxygen saturation target range
Eligibility 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
Sites / Locations
- University Medical Center, Ulm UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low target range
High target range
Arm Description
Low oxygen saturation target range: SpO2 85-89%
High oxygen saturation target range: SpO2 91-95%
Outcomes
Primary Outcome Measures
Duration SpO2 < 80%
Secondary Outcome Measures
Cerebral tissue oxygen saturation as measured by NIRS
Area under threshold
Arterial SpO2 as measured by pulse oxymetry
Area under 80%
Heart rate as measured by ECG
Area under 80/min
cerebral and visceral fractional oxygen extraction as measured by NIRS
Cardiac output as measured by Cardiovelocimetry
Number of hypoxemic and / or bradycardic events
Visceral tissue oxygen saturation as measured by NIRS
Area under threshold
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02743988
Brief Title
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
Official Title
Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Hypoxemia, Apnea of Prematurity
Keywords
cerebral oxygenation, NIRS, near-infrared spectroscopy, bradycardia, hypoxemia, cerebral perfusion, cardiac output, apnea, desaturation, oxygen saturation target range
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low target range
Arm Type
Experimental
Arm Description
Low oxygen saturation target range: SpO2 85-89%
Arm Title
High target range
Arm Type
Active Comparator
Arm Description
High oxygen saturation target range: SpO2 91-95%
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
Adapt inspired oxygen to achieve desired SpO2 target range
Primary Outcome Measure Information:
Title
Duration SpO2 < 80%
Time Frame
during 16 hours of measurement
Secondary Outcome Measure Information:
Title
Cerebral tissue oxygen saturation as measured by NIRS
Description
Area under threshold
Time Frame
during 16 hours of measurement
Title
Arterial SpO2 as measured by pulse oxymetry
Description
Area under 80%
Time Frame
during 16 hours of measurement
Title
Heart rate as measured by ECG
Description
Area under 80/min
Time Frame
during 16 hours of measurement
Title
cerebral and visceral fractional oxygen extraction as measured by NIRS
Time Frame
during 16 hours of measurement
Title
Cardiac output as measured by Cardiovelocimetry
Time Frame
during 16 hours of measurement
Title
Number of hypoxemic and / or bradycardic events
Time Frame
during 16 hours of measurement
Title
Visceral tissue oxygen saturation as measured by NIRS
Description
Area under threshold
Time Frame
during 16 hours of measurement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Days
Maximum Age & Unit of Time
42 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel B Schmid, MD
Phone
+41762515201
Email
manuel.schmid@uni-ulm.de
Facility Information:
Facility Name
University Medical Center, Ulm University
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel B Schmid
Phone
+49 731 500
Ext
57218
Email
manuel.schmid@uni-ulm.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants
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