Non-invasive Ventilation in Preterm Infants

Premature Birth Clinical Trial

Official title:

Non-invasive Ventilation in Preterm Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987800
• Other study ID #: NIV study
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: Julie Lefevere, MD
• Phone: 024777721
• Email: julie.lefevere[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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…)

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Ventilator Lung; Newborn

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.
• 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.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Rate of bronchopulmonary dysplasia (BPD) or death	Percentage of infants with BPD or death	From birth until gestational age of 36 weeks
Secondary	Duration of invasive respiratory support (days)		From birth until study completion, variating between 3 weeks and 3 months
Secondary	Duration of non-invasive respiratory support (days)		From birth until study completion, between 3 weeks and 3 months
Secondary	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
Secondary	Use of surfactant and mode of administration		From birth until study completion, between 3 weeks and 3 months
Secondary	Incidence of nosocomial infection		From birth until study completion, between 3 weeks and 3 months
Secondary	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
Secondary	Length of hospital stay	Days of stay in the neonatal unit	From birth until study completion, between 3 weeks and 3 months
Secondary	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
Secondary	NIV-NAVA breakpoint	Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol	At inclusion (within 24 hours)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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