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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Helmut Hummler, University of Ulm
ClinicalTrials.gov Identifier:
NCT01664832
First received: August 2, 2012
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Respiratory Distress Syndrome
Device: S-nIMV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • phasic esophageal pressure deflection [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cerebral oxygen saturation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Arterial oxygen saturation [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: July 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-nIMV
nIMV synchronized using abdominal pressure capsule sensor device
Device: S-nIMV
Synchronization of nasal breaths to infant's own respiratory effort
Placebo Comparator: nIMV
non-synchronized nasal intermittent mandatory ventilation group
Device: S-nIMV
Synchronization of nasal breaths to infant's own respiratory effort

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664832

Contacts
Contact: Helmut Hummle, Prof. Dr. 0731-500-57168 helmut.hummler@uniklinik-ulm.de
Contact: Li Huang, Master 015776891592 hhuangli@hotmail.com

Locations
Germany
Children's Hospital University of Ulm Recruiting
Ulm, Baden-Wüttemberg, Germany, 89075
Principal Investigator: Helmut Hummler, Prof. Dr         
Sponsors and Collaborators
Prof. Dr. Helmut Hummler
Investigators
Principal Investigator: Hummler Helmut, Prof. Dr University of Ulm
  More Information

No publications provided

Responsible Party: Prof. Dr. Helmut Hummler, University of Ulm
ClinicalTrials.gov Identifier: NCT01664832     History of Changes
Other Study ID Numbers: ULMN_SIMV
Study First Received: August 2, 2012
Last Updated: June 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Ulm:
Premature Infants
snychronized ventilation
non-invasive ventilation
RDS

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 29, 2014