Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

April 14, 2016 updated by: Manuel Schmid, University of Ulm
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%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89075
        • Recruiting
        • University Medical Center, Ulm University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 weeks to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration SpO2 < 80%
Time Frame: during 16 hours of measurement
during 16 hours of measurement

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULMNEONIRS05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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