Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
120 participants
INTERVENTIONAL
2023-02-01
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Preterm infants on non-invasive respiratory support
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Infants can only be enrolled after written and signed informed consent by the parents.
Exclusion Criteria
* Infants with major congenital malformations or chromosomal abnormalities (eg trisomy 18, congenital diaphragmatic hernia…)
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Julie Lefevere, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Filip Cools, PhD
Role: STUDY_DIRECTOR
Universitair Ziekenhuis Brussel
Brenda Van Delft, Nurse
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel
Caitlin Jansen, Student
Role: STUDY_CHAIR
Vrije Universiteit Brussel
Lissa De Potter, MD
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel
Locations
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Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NIV study
Identifier Type: -
Identifier Source: org_study_id
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