Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm infants on non-invasive respiratory support | Other | All infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titration procedure | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration of respiratory support | Total number of days of invasive and non-invasive respiratory support | 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 | From birth until gestational age of 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Julie Lefevere, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Filip Cools, PhD | Universitair Ziekenhuis Brussel | Study Director |
| Brenda Van Delft, Nurse | Universitair Ziekenhuis Brussel | Study Chair |
| Caitlin Jansen, Student | Vrije Universiteit Brussel | Study Chair |
| Lissa De Potter, MD | Universitair Ziekenhuis Brussel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Jette | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17989387 | Background | Baraldi E, Filippone M. Chronic lung disease after premature birth. N Engl J Med. 2007 Nov 8;357(19):1946-55. doi: 10.1056/NEJMra067279. No abstract available. | |
| 30974433 | Background | Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11. |
Not provided
Not provided
Database on non-invasive ventilation has the potential to be shared but no concrete plan for sharing individual patient data is made.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D012128 | Respiratory Distress Syndrome |
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Electrical impedance tomography | Diagnostic Test | 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 and diaphragm ultrasound | Diagnostic Test | 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. |
|
| Description of mode of non-invasive respiratory support | Use of NIV-NAVA, CPAP, high flow nasal cannula, oxygen therapy | From birth until study completion, between 3 weeks and 3 months |
| 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 | Use of any corticosteroid (systemic or local) | From birth until study completion, between 3 weeks and 3 months |
| Length of hospital stay | Days of stay in the neonatal unit | 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 | 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 | At inclusion (within 24 hours) |
| Lung ultrasound score | Lung ultrasound score will be scored at several time points | 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 | 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) | 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) | 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) | 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 |
| 34533644 | Background | Lefevere J, Van Delft B, Vervoort M, Cools W, Cools F. Non-invasive neurally adjusted ventilatory assist in preterm infants with RDS: effect of changing NAVA levels. Eur J Pediatr. 2022 Feb;181(2):701-707. doi: 10.1007/s00431-021-04244-3. Epub 2021 Sep 17. |
| 30905442 | Background | Harada E, Kinoshita M, Iwata S, Saikusa M, Tsuda K, Shindou R, Sahashi T, Kato S, Yamada Y, Saitoh S, Iwata O. Visual function scale for identification of infants with low respiratory compliance. Pediatr Neonatol. 2019 Dec;60(6):611-616. doi: 10.1016/j.pedneo.2019.02.006. Epub 2019 Mar 2. |
| 33246967 | Background | Thomson J, Ruegger CM, Perkins EJ, Pereira-Fantini PM, Farrell O, Owen LS, Tingay DG. Regional ventilation characteristics during non-invasive respiratory support in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):370-375. doi: 10.1136/archdischild-2020-320449. Epub 2020 Nov 27. |
| 30127522 | Background | Raimondi F, Yousef N, Migliaro F, Capasso L, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2021 Sep;90(3):524-531. doi: 10.1038/s41390-018-0114-9. Epub 2018 Jul 20. |
| 32458563 | Background | Alonso-Ojembarrena A, Ruiz-Gonzalez E, Estepa-Pedregosa L, Armenteros-Lopez AI, Segado-Arenas A, Lubian-Lopez SP. Reproducibility and reference values of diaphragmatic shortening fraction for term and premature infants. Pediatr Pulmonol. 2020 Aug;55(8):1963-1968. doi: 10.1002/ppul.24866. Epub 2020 Jun 5. |
| D000091642 | Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |