Clinical trial NCT05839340: Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
Official title: Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: St George's, University of London
First posted: 2023-05-03
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Dual Centre Randomised Cross-Over Trial. Infants that meet inclusion criteria will be randomised to be ventilated with either NIV-NAVA or ACV for four hours, followed by the second mode of ventilation. There will be a 20-minute stabilisation period between ventilatory methods.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygenation Index (OI)
timeFrame: 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 outcomes:
measure: Respiratory Severity Score (RSS)
timeFrame: 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.
Other outcomes:
measure: Mean Airway Pressure (MAP)
timeFrame: 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.
measure: Fraction of Inspired Oxygen (FIO2)
timeFrame: 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.
measure: Peak Inspiratory Pressure (PIP)
timeFrame: 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.
measure: Morphine Equivalent Use
timeFrame: 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.
measure: Midazolam Equivalent Use
timeFrame: 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
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St. George's University Hospital
Study officials:
References: