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Influence of Oxygen Target Range on Intermittent Hypoxemia in Preterm Infants

NCT02743988 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-04-19

No results posted yet for this study

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%.

Conditions

  • Intermittent Hypoxemia
  • Apnea of Prematurity

Interventions

DRUG

Oxygen

Adapt inspired oxygen to achieve desired SpO2 target range

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Days
Max Age
42 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-04-30
Completion
2017-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02743988 on ClinicalTrials.gov