Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
NCT ID: NCT05839340
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
18 participants
INTERVENTIONAL
2023-05-26
2024-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Neurally Adjusted Ventilatory Assist
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).
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.
Assist Control Ventilation (ACV)
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Minute
28 Days
ALL
No
Sponsors
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St George's, University of London
OTHER
King's College Hospital NHS Trust
OTHER
Responsible Party
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Anne Greenough
Professor of Neonatology and Clinical Respiratory Physiology
Locations
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Kings College Hospital
London, , United Kingdom
St. George's University Hospital
London, , United Kingdom
Countries
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References
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Poole G, Harris C, Shetty S, Dassios T, Jenkinson A, Greenough A. Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study. Trials. 2024 Jan 20;25(1):72. doi: 10.1186/s13063-023-07874-0.
Other Identifiers
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319769
Identifier Type: -
Identifier Source: org_study_id
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