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New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates (NOONA)

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ClinicalTrials.gov Identifier: NCT04089540
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:

This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and control groups during intubation.

Hypothesis

  • The new intubation method is safe
  • The new intubation method leads to a reduction in the number of intubation attempts
  • The new intubation method leads to a reduction of desaturations and bradycardia during intubation
  • In the long term, it could lead to a reduction in morbidity and mortality

Condition or disease Intervention/treatment Phase
Intubation; Difficult or Failed Preterm Infant Term Infant Procedure: New intubation method Procedure: Conventional intubation method Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates. A Pilot Study
Actual Study Start Date : October 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: Study group: New intubation method
In the new intubation method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). Therefore an oxygen flow is already administered via the tube during the intubation process.
Procedure: New intubation method
Control group: Conventional intubation
In the control group the respirator is connected to the tube and ventilation is started after the insertion of the tube into the trachea. Therefore there is no oxygen flow administered during the intubation process.
Procedure: Conventional intubation method



Primary Outcome Measures :
  1. Number of intubation attempts [ Time Frame: During intubation process ]
    Changes in the number of intubation attempts


Secondary Outcome Measures :
  1. Duration of intubation process in minutes [ Time Frame: During intubation process ]
    Changes in duration

  2. Number of desaturations [ Time Frame: During intubation process ]

    The number of desaturations below 80% SpO2

    The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.


  3. Total amount of time of desaturations [ Time Frame: During intubation process ]

    The total amount of time in seconds a patient spends below 80% SpO2.

    The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.


  4. Cerebral tissue oxygenation [ Time Frame: 5 minutes before intubation start till 10 minutes after successful intubation ]
    Using near-infrared spectroscopy to monitor changes of the cerebral tissue oxygenation

  5. Morbidity [ Time Frame: up to 2 years ]
    Changes in morbidity

  6. Mortality [ Time Frame: up to 2 years ]
    Changes in mortality



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
  • Fulfillment of indication for intubation

Exclusion Criteria:

- Malformation of the upper respiratory tract


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089540


Contacts
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Contact: Nicholas Morris, MD 0043 316 385 81126 nicholas.morris@medunigraz.at
Contact: Marlies Bruckner, MD 0043 316 385 30752 marlies.bruckner@medunigraz.at

Locations
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Austria
Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Nicholas Morris, MD    +43 316 385 81126    nicholas.morris@medunigraz.at   
Principal Investigator: Nicholas Morris, MD         
Sub-Investigator: Berndt Urlesberger, Professor         
Sub-Investigator: Gerhard Pichler, Assoz. Prof.         
Sub-Investigator: Marlies Bruckner, MD         
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Nicholas Morris, MD Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria

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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04089540     History of Changes
Other Study ID Numbers: NOONA
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No