Non-invasive Ventilation in Preterm Infants

NCT05987800 | Active Not Recruiting

• 1 other identifier: NIV study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Respiratory Distress Syndrome; Ventilator Lung; Newborn

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (14)

• 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

• Description of mode of non-invasive respiratory support

  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

Study Arms (1)

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.

Diagnostic Test: Titration procedure; Diagnostic Test: Electrical impedance tomography; Diagnostic Test: Lung and diaphragm ultrasound

Interventions

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.

Preterm infants on non-invasive respiratory support

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.

Preterm infants on non-invasive respiratory support

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.

Preterm infants on non-invasive respiratory support

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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…)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (7)

• 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.

  PMID: 17989387 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.

  PMID: 30974433 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.

  PMID: 34533644 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.

  PMID: 30905442 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.

  PMID: 33246967 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.

  PMID: 30127522 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.

  PMID: 32458563 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: August 14, 2023
• Study Start: February 1, 2023
• Primary Completion: June 3, 2025
• Study Completion: September 30, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)