NAN-C
Research type
Research Study
Full title
Neurally Adjusted Ventilatory Assist for Neonates with Congenital Diaphragmatic Hernia
IRAS ID
319769
Contact name
Christopher Harris
Contact email
Sponsor organisation
The R&I Office
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Congenital diaphragmatic hernias (CDH) are a defect in the development of the diaphragm enabling abdominal contents to protrude into the thoracic cavity, impeding lung development. The defect is typically repaired surgically within the first few days of an infant's life. Following surgical repair, infants with CDH typically require ventilatory support of the lungs to ensure adequate oxygenation.
Traditionally, assist control (AC) ventilation has been used to support infants with CDH. AC is a pressure-control method of ventilation, which means it delivers a fixed amount of oxygen when the infant initiates a breath. Delivering fixed oxygen pressures can result in barotrauma, the consequences of which include long-term lung damage.
A more recent approach to ventilation, is a method termed non-invasive neurally adjusted ventilatory assist (NAVA). This method uses computer software to detect electrical signals produced by the diaphragm when an infant breathes and delivers a proportional volume of oxygen. Evidence suggests that NAVA may reduce physiological parameters associated with lung pressure and hence reduce the risk of iatrogenic lung injury. Whilst NAVA has been shown to be effective for infants with broncho-pulmonary dysplasia and in low birth-weight infants, limited studies have looked at its use for CDH. Studies that have investigated its use in CDH are limited by small sample size and their retrospective nature.
Within this study, we want to evaluate the effectiveness of NAVA for infants born at term with CDH. We will compare the amount of oxygen required and measures of lung pressure of infants ventilated with NAVA, compared to ACV. Newborns will be ventilated with NAVA and ACV for a period of 4-hours, The order in which infants receive each mode of ventilation will be random to ensure the study is fair.
REC name
West of Scotland REC 4
REC reference
23/WS/0070
Date of REC Opinion
26 May 2023
REC opinion
Further Information Favourable Opinion