This is a prospective, observational cohort study. For the study part on noninvasive neurally adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants prospective data collection will be conducted by chart review and by downloading ventilatory data from the ventilator. A registration of respiratory severity score will be done by a caregiver during the weaning period. This consists of a visual assessment of the work of breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part of the study a titration procedure will be conducted, afterwards serial electrical impedance tomography and lung and diaphragm ultrasound measurements will be done.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The NAVA level will be reduced to 0,5 cmH2O/microvolt (µV) for 3 minutes as a starting point. Limit peak pressure will be set to 35 cmH2O (the maxi-mum pressure that can be delivered to the patient is cut off at 30 cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated. Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 2,5 cmH2O/µV.
This is a non-invasive technique consisting of the application of a non-adhesive single-use patient belt to monitor regional changes in lung aeration at the bedside.
Lung ultrasound is a non-invasive technique used to diagnose lung pathology and to monitor lung condition. This technique is part of the standard of care for preterm infants in our neonatal unit. Lung ultrasound scores are calculated at each time an ultrasound is performed. Ultrasound of the diaphragm consists of a short additional measurement of diaphragm thickness and thickening fraction and will be done at the same time of the lung ultrasound following a standardized procedure.
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
Total duration of respiratory support
Total number of days of invasive and non-invasive respiratory support
Time frame: From birth until study completion, variating between 3 weeks and 3 months
Rate of bronchopulmonary dysplasia (BPD) or death
Percentage of infants with BPD or death
Time frame: From birth until gestational age of 36 weeks
Duration of invasive respiratory support (days)
Time frame: From birth until study completion, variating between 3 weeks and 3 months
Duration of non-invasive respiratory support (days)
Time frame: From birth until study completion, between 3 weeks and 3 months
Description of mode of non-invasive respiratory support
Use of NIV-NAVA, CPAP, high flow nasal cannula, oxygen therapy
Time frame: From birth until study completion, between 3 weeks and 3 months
Use of surfactant and mode of administration
Time frame: From birth until study completion, between 3 weeks and 3 months
Incidence of nosocomial infection
Time frame: From birth until study completion, between 3 weeks and 3 months
Use of corticosteroids for the prevention or treatment of BPD
Use of any corticosteroid (systemic or local)
Time frame: From birth until study completion, between 3 weeks and 3 months
Length of hospital stay
Days of stay in the neonatal unit
Time frame: From birth until study completion, between 3 weeks and 3 months
Respiratory severity score (RSS)
RSS will be measured during the weaning phase of non-invasive respiratory support
Time frame: From start of the weaning phase until respiratory support is stopped, up to 10 weeks
NIV-NAVA breakpoint
Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol
Time frame: At inclusion (within 24 hours)
Lung ultrasound score
Lung ultrasound score will be scored at several time points
Time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
Diaphragm ultrasound
Measurement of diaphragm thickness with ultrasound
Time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
Silent Spaces
Parts (in % of global lung volume) of the lung that are not ventilated as measured with electrical impedance tomography (EIT)
Time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks
Tidal volume (TV)
Percentage of TV per 'Region of Interest' (ROI) as measured with electrical impedance tomography (EIT)
Time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks
Center of Ventilation (CoV)
As measured with electrical impedance tomography (EIT)
Time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.