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

New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates. A Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Intubation; Difficult or Failed; Preterm Infant; Term Infant
• Intervention / Treatment: Procedure: New intubation method; Procedure: Conventional intubation method

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 4 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of intubation attempts	Changes in the number of intubation attempts	During intubation process

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of intubation process in minutes	Changes in duration	During intubation process
Number of desaturations	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.	During intubation process
Total amount of time of desaturations	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.	During intubation process
Cerebral tissue oxygenation	Using near-infrared spectroscopy to monitor changes of the cerebral tissue oxygenation	5 minutes before intubation start till 10 minutes after successful intubation
Morbidity	Changes in morbidity	up to 2 years
Mortality	Changes in mortality	up to 2 years

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Nicholas Morris, MD, Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NOONA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No