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Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants? (N_SIMV)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Prof. Dr. Helmut Hummler, University of Ulm.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01664832
First Posted: August 14, 2012
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Dr. Helmut Hummler, University of Ulm
August 2, 2012
August 14, 2012
June 27, 2013
July 2012
September 2013   (Final data collection date for primary outcome measure)
phasic esophageal pressure deflection [ Time Frame: 4 hours ]
Same as current
Complete list of historical versions of study NCT01664832 on ClinicalTrials.gov Archive Site
  • Cerebral oxygen saturation [ Time Frame: 4 hours ]
  • Arterial oxygen saturation [ Time Frame: 4 hours ]
Same as current
Not Provided
Not Provided
 
Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?
Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?

The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).

Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.

In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.

Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Respiratory Distress Syndrome
Device: S-nIMV
Synchronization of nasal breaths to infant's own respiratory effort
  • Experimental: S-nIMV
    nIMV synchronized using abdominal pressure capsule sensor device
    Intervention: Device: S-nIMV
  • Placebo Comparator: nIMV
    non-synchronized nasal intermittent mandatory ventilation group
    Intervention: Device: S-nIMV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
18
Not Provided
September 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.

  • Gestational age <32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
  • Informed consent available.

Exclusion Criteria:

• Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01664832
ULMN_SIMV
No
Not Provided
Not Provided
Prof. Dr. Helmut Hummler, University of Ulm
Prof. Dr. Helmut Hummler
Not Provided
Principal Investigator: Hummler Helmut, Prof. Dr University of Ulm
University of Ulm
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP