Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias

Congenital Diaphragmatic Hernia Clinical Trial

— NAN-C  

Official title:

Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05839340
• Other study ID #: 319769
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Our dual-centre randomised cross-over trial aims to investigate the efficacy of NIV-NAVA compared to ACV for supporting neonates with CDH.

Description:

Background:

Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Evidence suggests that NAVA may reduce physiological parameters associated with lung pressure and hence reduce the risk of iatrogenic lung injury.

Aims:

Our aim is to compare the oxygenation index (OI) of neonates with CDH, ventilated with ACV and NIV-NAVA. The OI is calculated as the fractured of inspired oxygen x mean airway pressure x partial pressure of oxygen/100. The oxygenation index is used as a marker of hypoxic respiratory failure in infants with CDH and forms the basis of the criteria to administer nitric oxide.

Methods:

Our investigation is a dual-centre randomised cross-over trial. Infants will be identified and parents counselled in the first few days following delivery. Neonates that meet inclusion criteria will be randomised to receive either NIV-NAVA or ACV first, followed by the other method of ventilation. Infants will be stabilised on ACV one-hour prior to entering the trial. On entry into the trial, they will receive 4-hours of each ventilatory method with a 20-minute stabilisation break in between.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 28 Days

Eligibility

Inclusion Criteria:

• Infants born with congenital diaphragmatic hernia more than 34-weeks gestation

Exclusion Criteria:

• Receiving Nitric Oxide

• Requiring an FIO2 more than 80% to maintain SpO2: 85-95%.

• Severe chromosomal abnormality

• Severe cardiac anomalies requiring corrective surgery

• Renal anomalies

• Skeletal deformities suspected to impede thoracic or lung development

• Severe central nervous system anomalies suspected to impede diaphragmatic signalling

• Use of neuromuscular blocking agents

• Contraindication to nasogastric tube insertion

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic
• Hernias, Diaphragmatic, Congenital

Intervention

Device:
• Neurally Adjusted Ventilatory Assist
NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen, to which proportion is set by the clinician as the NAVA level.
• Assist Control Ventilation
ACV delivers fixed oxygen pressure set by the clinician at the start of each inspiratory breath.

Locations

Country	Name	City	State
United Kingdom	Kings College Hospital	London
United Kingdom	St. George's University Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Airway Pressure (MAP)	The MAP is mean pressure the lungs are exposed to during inspiration and expiration. Mean airway pressure is one of the main determinants of oxygenation.	MAP will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Other	Fraction of Inspired Oxygen (FIO2)	The FIO2 is the concentration of oxygen delivered expressed as a percentage.	FIO2 will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Other	Peak Inspiratory Pressure (PIP)	Peak Inspiratory Pressure is defined as the pressure reached at the end of inspiration.	PIP will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Other	Morphine Equivalent Use	Analgesic medication will be used with a basal-bolus regimen with the option for as required analgesia based on perceived pain and agitation.	The cumulative total of morphine used during the four-hour period on each ventilation mode will be calculated. This will be compared between ventilation modes.
Other	Midazolam Equivalent Use	Cumulative midazolam use on each ventilatory method will be calculated.	The cumulative total of midazolam, or equivalent benzodiezapine, used during the four-hour period on each ventilation mode will be calculated. This will be compared between ventilation modes
Primary	Oxygenation Index (OI)	Oxygenation Index is calculated as MAP x FIO2 x PaO2/100. MAP is the mean airway pressure. FIO2 represents the concentration of inspired oxygen and PAO2 is the partial pressure of oxygen. The OI is a reliable indicator of lung function, previous research has shown its use in the prognostication of neonates with CDH.	Infants will receive each mode of ventilation for four hours. OI will be recorded every 5-minutes for the final 30-minutes of each ventilation period. The OI will be averaged over the 30-minute time frame. This average OI will then be compared.
Secondary	Respiratory Severity Score (RSS)	The respiratory severity score is calculated as RSS = FIO2 x MAP. Where FIO2 represents the fraction of inspired oxygen and MAP is the mean airway pressure. In one multivariate analysis of 59 infants with CDH, RSS was an effective prognostic marker.	RSS will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.