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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333563
• Other study ID #: 58386
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2022
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Hours to 96 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• CPAP
Continuous positive airway pressure
• NIV NAVA
Non-invasive neurally adjusted ventilatory assist

Locations

Country	Name	City	State
Norway	Department of Pediatrics St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrical activity of the diaphragm	Electromyography signals from the diaphragm in 30 second intervals	9 hours and 30 minutes
Secondary	Silverman Andersen Respiratory Severity Score	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
Secondary	Scoring blinded for the intervention	During each intervention, the infants will be video recorded for a blinded assessment.	Three minutes video-recording
Secondary	COMFORTneo pain scale	Measuring pain and discomfort in a seven category scale graded from 1 - 5, where one is best and five is worse.	Three minutes
Secondary	Parents opinion about the outcomes	Three questions about their opinion about the interventions in a 5 point Likert scale	Three minutes
Secondary	Respiratory rate	Standard monitoring on IntelliVue monitor	30 second intervals
Secondary	Heart rate	Standard monitoring on IntelliVue monitor	30 second intervals
Secondary	Oxygen saturation	Standard monitoring on IntelliVue monitor	30 second intervals
Secondary	number of apneic episodes = 20 seconds	Using trend function on the IntelliVue monitor	9 hours and 30 seconds