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

NCT01942473 | Completed

• 1 other identifier: FiO2_Ulm
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Infant; RDS

Outcome Measures

Primary Outcomes (1)

• Cerebral tissue oxygen saturation

  mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed

  48 hours

Secondary Outcomes (3)

• number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%)

  48 hours

• time within a defined target range of cerebral oxygen saturation (59% - 81%)

  48 hours

• workload for the medical staff related to number of adjustments of FiO2

  48 hours

Study Arms (2)

Automated FiO2 control

EXPERIMENTAL

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.

Device: Automated FiO2 Control

Manual Adjustment

PLACEBO COMPARATOR

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.

Interventions

Automated FiO2 Control DEVICE

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

Automated FiO2 control

Eligibility Criteria

• Age: 96 Hours - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Children's Hospital University of Ulm

Ulm, 89070, Germany

Location

Related Publications (1)

• 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.

  PMID: 25454938 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Markus Waitz, MD

  Children's Hospital, University of Ulm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Division of Neonatology and Pediatric Critical Care

Study Record Dates

• First Submitted: August 3, 2012
• First Posted: September 16, 2013
• Study Start: August 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: April 1, 2014
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

DE (1)