Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000157

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

CLAC

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.medizin.uni-tuebingen.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Preterm infants often need additional oxygen due to their immature lungs. However, additional oxygen could be harmful to lungs, eyes, and brain and should be adjusted appropriately. In preterm infants manual control of additional oxygen is often time-consuming and sometimes difficult. We, thus, developed a computer system for automatic oxygen control and tested this system in non-ventilated preterm infants with good results. Now, we would like to test the system in ventilated preterm infants in three different hospitals.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background: In preterm infants receiving supplemental oxygen, manual control of the inspired oxygen fraction is often time-consuming and inappropriate. We developed a system for automatic oxygen control and evaluated this system in non-invasive ventilated preterm infants.
Aims: To assess long-term performance and acceptance by personnel of the system in a multicenter setting.
Methods: Multicenter randomized controlled cross-over clinical trial. Following a run-in-phase, 24-hour-periods with automatic and routine manual oxygen control will be compared regarding the percentage of time with arterial oxygen saturation levels within target range.
Patients: 54 preterm infants receiving supplemental oxygen (FiO2 > 0.25) and invasive or non-invasive ventilation.
Statistical analysis: Analysis of variance and pair-wise post-hoc comparisons.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000157
  •   2009/08/19
  •   [---]*
  •   yes
  •   Approved
  •   7/2006, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1111-5698 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   P07.3 -  Other preterm infants
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   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).
  •   Cross-over design: intervention B (24-hour PC-based automatic oxygen control) will be followed by intervention A (24-hour manual oxygen control by nurses).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Supportive care
  •   Crossover
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

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

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/04/21
  •   54
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   0   Days
  •   4   Months
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung für Neonatologie Klinik für Kinder- und Jugendmedizin Universitätsklinikum Tübingen
    • Mr.  Prof. Dr. med.  Christian F.  Poets 
    • Calwerstr. 7
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Medizinische Biometrie, Epidemiologie und Informatik Universitätsmedizin der Johannes Gutenberg Universität Mainz
    • Mr.  Univ.-Prof. Dr. med.  Michael  Urschitz 
    • Obere Zahlbacher Str. 69
    • 55131  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Kinder- und Jugendmedizin Universitätsklinikum Tübingen
    • Ms.  Dr. med.  Antonietta  Hallenberger 
    • Calwerstr. 7
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Heinen + Löwenstein GmbH
    • Arzbacher Straße 80
    • 56130  Bad Ems
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting stopped after recruiting started
  •   2012/03/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Closed-Loop Automatic Oxygen Control (CLAC) in Preterm Infants: A Randomized Controlled Trial. Hallenberger A, Poets CF, Horn W, Seyfang A, Urschitz MS; CLAC Study Group. Pediatrics. 2014 Feb;133(2):e379-85. doi: 10.1542/peds.2013-1834. Epub 2014 Jan 27.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.