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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000157

Enrollment

Registered

2009-08-19

Start date

2009-04-21

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.3

Interventions

Group 1: Cross-over design: intervention A (24-hour manual oxygen control by nurses) will be followed by intervention B (24-hour PC-based automatic oxygen control). Group 2: Cross-over design: interve

Eligibility

Sex/Gender

All

Age

0 Days to 4 Months

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: cyanotic heart defect validated by echocardiography diaphragmatic hernia or other diaphragmatic defect

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary outcome variables are the frequency and duration of hypoxic and hyperoxic episodes.	—

Countries

Germany

Contacts

Public ContactAntonietta Hallenberger

Klinik für Kinder- und Jugendmedizin Universitätsklinikum Tübingen

antonietta.hallenberger@med.uni-tuebingen.de07071.29.84742

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026