Non-invasive Ventilation in Preterm Infants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Preterm infants on non-invasive respiratory support All infants on non-invasive respiratory support will be studied. Only infants on NIV-NAVA, will undergo an intervention. |
Diagnostic Test: Titration 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 Test: Electrical 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 Test: Lung 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.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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, variating between 3 weeks and 3 months]
- Description of mode of non-invasive respiratory support [From birth until study completion, variating between 3 weeks and 3 months]
Use of NIV-NAVA, CPAP, HHHFNC, oxygen therapy
- Use of surfactant and mode of administration [From birth until study completion, variating between 3 weeks and 3 months]
- Incidence of nosocomial infection [From birth until study completion, variating between 3 weeks and 3 months]
- Use of corticosteroids for the prevention or treatment of BPD [From birth until study completion, variating between 3 weeks and 3 months]
Use of any corticosteroid (systemic or local)
- Length of hospital stay [From birth until study completion, variating 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Preterm infants (< 37 weeks GA) supported with non-invasive respiratory support. 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).
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Infants can only be enrolled after written and signed informed consent by the parents.
Exclusion Criteria:
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Infant born after a gestational age of 37 weeks or more.
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Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia…)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitair Ziekenhuis Brussel | Jette | Brussel | Belgium | 1090 |
Sponsors and Collaborators
- Universitair Ziekenhuis Brussel
Investigators
- Principal Investigator: Julie Lefevere, MD, Universitair Ziekenhuis Brussel
- Study Director: Filip Cools, PhD, Universitair Ziekenhuis Brussel
- Study Chair: 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 Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- NIV study