Premature Birth, Respiratory Distress Syndrome, Ventilator Lung; Newborn
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTTitration procedure
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.
DIAGNOSTIC_TESTElectrical impedance tomography
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.
DIAGNOSTIC_TESTLung and diaphragm ultrasound
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.
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Preterm infants (\< 37 weeks GA) supported with non-invasive respiratory support for at least 24 hours. Non-invasive respiratory support can consist of non-invasive NAVA, nasal continuous positive airway pressure (nCPAP) or high flow nasal canula (flow \> 2 liters/min).The support can be given as primary respiratory support or as respiratory support after weaning from invasive ventilation (= after extubation). * Infants can only be enrolled after written and signed informed consent by the parents.
Exclusion criteria
* Infant born after a gestational age of 37 weeks or more. * Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia…)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of respiratory support | From birth until study completion, variating between 3 weeks and 3 months | Total number of days of invasive and non-invasive respiratory support |
| Rate of bronchopulmonary dysplasia (BPD) or death | From birth until gestational age of 36 weeks | Percentage of infants with BPD or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of invasive respiratory support (days) | From birth until study completion, variating between 3 weeks and 3 months | — |
| Duration of non-invasive respiratory support (days) | From birth until study completion, between 3 weeks and 3 months | — |
| Description of mode of non-invasive respiratory support | From birth until study completion, between 3 weeks and 3 months | Use of NIV-NAVA, CPAP, high flow nasal cannula, oxygen therapy |
| Use of surfactant and mode of administration | From birth until study completion, between 3 weeks and 3 months | — |
| Incidence of nosocomial infection | From birth until study completion, between 3 weeks and 3 months | — |
| Use of corticosteroids for the prevention or treatment of BPD | From birth until study completion, between 3 weeks and 3 months | Use of any corticosteroid (systemic or local) |
| Length of hospital stay | From birth until study completion, between 3 weeks and 3 months | Days of stay in the neonatal unit |
| Respiratory severity score (RSS) | From start of the weaning phase until respiratory support is stopped, up to 10 weeks | RSS will be measured during the weaning phase of non-invasive respiratory support |
| NIV-NAVA breakpoint | At inclusion (within 24 hours) | Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol |
| Lung ultrasound score | At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks | Lung ultrasound score will be scored at several time points |
| Diaphragm ultrasound | At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks | Measurement of diaphragm thickness with ultrasound |
| Silent Spaces | 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 | Parts (in % of global lung volume) of the lung that are not ventilated as measured with electrical impedance tomography (EIT) |
| Tidal volume (TV) | 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 | Percentage of TV per 'Region of Interest' (ROI) as measured with electrical impedance tomography (EIT) |
| Center of Ventilation (CoV) | 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 | As measured with electrical impedance tomography (EIT) |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORJulie Lefevere, MD
Universitair Ziekenhuis Brussel
STUDY_DIRECTORFilip Cools, PhD
Universitair Ziekenhuis Brussel
STUDY_CHAIRBrenda Van Delft, Nurse
Universitair Ziekenhuis Brussel
STUDY_CHAIRCaitlin Jansen, Student
Vrije Universiteit Brussel
STUDY_CHAIRLissa De Potter, MD
Universitair Ziekenhuis Brussel
Outcome results
None listed