CLINICAL LONG-TERM EVALUATION OF AN AUTOMATIC CONTROL OF THE INSPIRED OXYGEN FRACTION IN VENTILATED PRETERM INFANTS

Not Applicable

• Conditions: P07.3; Other preterm infants

• Registration Number: DRKS00000157
• Lead Sponsor: Abteilung für NeonatologieKlinik für Kinder- und JugendmedizinUniversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-19
• Study Completion: 2012-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

preterm birth (gestational age <37+0/7 weeks)
invasive ventilation or CPAP
at least 0.25 FiO2
informed parental consent

Exclusion Criteria

cyanotic heart defect validated by echocardiography
diaphragmatic hernia or other diaphragmatic defect

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome variable is the percentage of time within a predefined target range of the puls oximetry-derived haemoglobin oxygen saturation. The target range depends on the study center.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome variables are the frequency and duration of hypoxic and hyperoxic episodes.