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Effects of Automated Adjustment of FiO2 on Cerebral and Arterial Oxygenation in Preterm Infants

NCT ID: NCT01942473

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Preterm Infant RDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Automated FiO2 control

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.

Group Type EXPERIMENTAL

Automated FiO2 Control

Intervention Type DEVICE

Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.

Manual Adjustment

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.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Automated FiO2 Control

Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

96 Hours

Maximum Eligible Age

30 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Helmut Hummler

Chief Division of Neonatology and Pediatric Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Waitz, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, University of Ulm

Locations

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Children's Hospital University of Ulm

Ulm, , Germany

Site Status

Countries

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Germany

References

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Waitz M, Schmid MB, Fuchs H, Mendler MR, Dreyhaupt J, Hummler HD. Effects of automated adjustment of the inspired oxygen on fluctuations of arterial and regional cerebral tissue oxygenation in preterm infants with frequent desaturations. J Pediatr. 2015 Feb;166(2):240-4.e1. doi: 10.1016/j.jpeds.2014.10.007. Epub 2014 Nov 18.

Reference Type DERIVED
PMID: 25454938 (View on PubMed)

Other Identifiers

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FiO2_Ulm

Identifier Type: -

Identifier Source: org_study_id