Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants (FiO2-Contr)

University of Ulm

Status: Completed

Conditions: Preterm Infant; RDS

Treatments: Device: Automated FiO2 Control

Study type: Interventional

Funder types: Other

Identifiers

NCT01942473

FiO2_Ulm

Details and patient eligibility

About

In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.

Full description

Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).

Enrollment: 17 patients

Sex: All

Ages: 96 hours to 30 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• postmenstrual age <30 wks GA at study time
• on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV)
• at least 4 desaturations (SpO2 <80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)

Exclusion criteria

• postnatal age <96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH)
• congenital cyanotic heart disease
• no decision for full treatment support
• Average FiO2 during the last 24h bevor the active study phase >0.60
• Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...)
• Clinically clear evidence for seizures
• Ongoing Sepsis (CRP > 10mg/l, or positive blood culture, requirement of catecholamines)
• Need of blood-transfusion during study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 2 patient groups, including a placebo group

Automated FiO2 control

Experimental group

Description:

Infants will be changed to a specific ventilator device approved for clinical use in neonates in Germany (Avea, Carefusion 234 GmbH Hoechberg, Germany), which is capable to automatically adjust the FiO2 based on readings of an incorporated SpO2 monitoring device. Infants will be allowed to adjust for at least 2h using the ventilator settings as chosen by the clinical team responsible. Thereafter, data will be recorded for 24h experimental time.

Treatment:

Device: Automated FiO2 Control

Manual Adjustment

Placebo Comparator group

Description:

Infants will be exposed to the first study phase (clinical routine or automated FiO2 adjustment) for 24 h and then will be switched to the alternate mode (automated FiO2 adjustment or clinical routine) for another 24 h.