Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05839340
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-01
First Post:
2023-04-07
Brief Title:
Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAN-C
Brief Summary:
Congenital Diaphragmatic Hernias CDH are typically repaired surgically in the first few days of a neonates 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 neonates 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 oxygen100 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
Congenital Diaphragmatic Hernias CDH are typically repaired surgically in the first few days of a neonates 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 oxygen100 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None