Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias (NAN-C)

King's College Hospital NHS Trust

Status: Active, not recruiting

Conditions: Congenital Diaphragmatic Hernia

Treatments: Device: Neurally Adjusted Ventilatory Assist; Device: Assist Control Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT05839340

319769

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 1 minute to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Neurally Adjusted Ventilatory Assist

Experimental group

Description:

Infants will first be ventilated with NAVA for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with assist control ventilation (ACV).

Treatment:

Device: Assist Control Ventilation

Device: Neurally Adjusted Ventilatory Assist

Assist Control Ventilation (ACV)

Experimental group

Description:

Infants will first be ventilated with ACV for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with non-invasive neurally adjusted ventilatory assist.

Treatment:

Device: Assist Control Ventilation

Device: Neurally Adjusted Ventilatory Assist