Clinical trial NCT05987800: Non-invasive Ventilation in Preterm Infants
Official title: Non-invasive Ventilation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Respiratory Distress Syndrome
Ventilator Lung; Newborn
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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...)

Primary outcomes:
measure: Total duration of respiratory support
timeFrame: From birth until study completion, variating between 3 weeks and 3 months
measure: Rate of bronchopulmonary dysplasia (BPD) or death
timeFrame: From birth until gestational age of 36 weeks
Secondary outcomes:
measure: Duration of invasive respiratory support (days)
timeFrame: From birth until study completion, variating between 3 weeks and 3 months
measure: Duration of non-invasive respiratory support (days)
timeFrame: From birth until study completion, between 3 weeks and 3 months
measure: Description of mode of non-invasive respiratory support
timeFrame: From birth until study completion, between 3 weeks and 3 months
measure: Use of surfactant and mode of administration
timeFrame: From birth until study completion, between 3 weeks and 3 months
measure: Incidence of nosocomial infection
timeFrame: From birth until study completion, between 3 weeks and 3 months
measure: Use of corticosteroids for the prevention or treatment of BPD
timeFrame: From birth until study completion, between 3 weeks and 3 months
measure: Length of hospital stay
timeFrame: From birth until study completion, between 3 weeks and 3 months
measure: Respiratory severity score (RSS)
timeFrame: From start of the weaning phase until respiratory support is stopped, up to 10 weeks
measure: NIV-NAVA breakpoint
timeFrame: At inclusion (within 24 hours)
measure: Lung ultrasound score
timeFrame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
measure: Diaphragm ultrasound
timeFrame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
measure: Silent Spaces
timeFrame: 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
measure: Tidal volume (TV)
timeFrame: 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
measure: Center of Ventilation (CoV)
timeFrame: 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
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Julie Lefevere, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Filip Cools, PhD
role: STUDY_DIRECTOR
affiliation: Universitair Ziekenhuis Brussel
name: Brenda Van Delft, Nurse
role: STUDY_CHAIR
affiliation: Vrije Universiteit Brussel
name: Caitlin Jansen, Student
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel
name: Lissa De Potter, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
citation: 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.