Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants

July 13, 2022 updated by: St. Olavs Hospital

Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants: A Randomized Crossover Study

Strategies to prevent lung injury, facilitate lung development, and to support the preterm infant's capacity to breathe are decisive. Continuous positive airway pressure (CPAP) is the gold standard in non-invasive breathing support in preterm infants with a positive pressure that keeps the alveoli slightly inflated during expiration. Non-invasive neurally adjusted ventilator assist (NIV NAVA) is a novel method of breathing support and uses the electrical activity from the diaphragm to trigger the ventilator and synchronize with the breathing cycle. During NIV NAVA the preterm infant controls the onset of the inspiration, the respiratory rate, inspiratory time and peak pressure. This method has the potential to improve the positive pressure transmission to the infant's lower airways, accurate synchronization with the breathing pattern and be a comfortable breathing support system for the preterm infant.

The investigators will compare the effect on breathing effort in preterm infants during continuous positive airway pressure and non-invasive neurally adjusted ventilatory assist measured by electrical activity in the diaphragm, respiratory vital signs, systematic clinical scoring of breathing effort and comfort, and parent reported outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized cross-over study with AB/BA sequences. The infants will receive both interventions in 4 hours intervals, a 30 minutes period to change the breathing support and a 30 minutes wash out period between interventions. Initially positive end expiratory pressure are set to 5 cm H2O and can be adjusted up to 7 cm H2O if needed decided by the medical team for both interventions. The neurally adjusted level will be set to obtain average Edi peak < 15 microvolt. Back-up setting and apnea time in the ventilator assist intervention (NIV NAVA) will be individualized according to clinical parameters in each preterm infant.

Modification approved by ethical committee REK 2021, 6th of August:

After two hours in each intervention, the nurse responsible for the infant will perform the clinical scoring. In addition it will be investigated if there is a difference in respiratory vital signs during skin to skin care and in the incubator. During each intervention period, the preterm infants are placed on the parent's chest skin to skin for at least one hour.

A modified version of the scoring tool will be used, i.e. without the item of nasal flaring and expiratory grunting. The headgear for CPAP and NIV NAVA covers parts of the nose and makes nasal flaring difficult to observe.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Department of Pediatrics St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spontaneously breathing preterm infants 24 to 96 hours old
  • gestational age (GA) between week 28+0 and 31+6
  • preterm infants with GA < 28+0 with a postmenstrual age (PMA) > 28 weeks
  • at least 72 hours old treated with CPAP or NIV NAVA

Exclusion Criteria:

  • preterm infants with severe congenital malformation
  • need for vasopressors
  • preterm children in need of a specific respiratory support system due to medical reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CPAP
respiratory stressed infants getting Continuous positive airway pressure (CPAP)
Device: CPAP
Continuous positive airway pressure
Device: NIV NAVA
Non-invasive neurally adjusted ventilatory assist
Experimental: respiratory stressed infants getting NIV NAVA
respiratory stressed infants getting Non-invasive neurally adjusted ventilatory assist (NIV NAVA)
Device: CPAP
Continuous positive airway pressure
Device: NIV NAVA
Non-invasive neurally adjusted ventilatory assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrical activity of the diaphragm
Time Frame: 9 hours and 30 minutes
Electromyography signals from the diaphragm in 30 second intervals
9 hours and 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Silverman Andersen Respiratory Severity Score
Time Frame: Three minutes
The scoring tool consists of 5 categories and respiratory distress are graded from zero to two for each category. Respiratory distress gets worse the higher the total score gets.
Three minutes
Scoring blinded for the intervention
Time Frame: Three minutes video-recording
During each intervention, the infants will be video recorded for a blinded assessment.
Three minutes video-recording
COMFORTneo pain scale
Time Frame: Three minutes
Measuring pain and discomfort in a seven category scale graded from 1 - 5, where one is best and five is worse.
Three minutes
Parents opinion about the outcomes
Time Frame: Three minutes
Three questions about their opinion about the interventions in a 5 point Likert scale
Three minutes
Respiratory rate
Time Frame: 30 second intervals
Standard monitoring on IntelliVue monitor
30 second intervals
Heart rate
Time Frame: 30 second intervals
Standard monitoring on IntelliVue monitor
30 second intervals
Oxygen saturation
Time Frame: 30 second intervals
Standard monitoring on IntelliVue monitor
30 second intervals
number of apneic episodes ≥ 20 seconds
Time Frame: 9 hours and 30 seconds
Using trend function on the IntelliVue monitor
9 hours and 30 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Study Director: Elisabeth Selvaag, md, St Olavs Hospital, Barne- og ungdomsklinikk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58386

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study protocol Statistical analysis Informed consent form

IPD Sharing Time Frame

2022 and to 2027

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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