Premature BirthNCT05987800

Non-invasive Ventilation in Preterm Infants

A study testing Titration procedure, Electrical impedance tomography and Lung and diaphragm ultrasound in people with Premature Birth and Respiratory Distress Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Premature Birth, Respiratory Distress Syndrome, Ventilator Lung; Newborn
What is being tested?: Titration procedure, Electrical impedance tomography and Lung and diaphragm ultrasound
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteBelgium
Study dates: 1 Feb 2023to 30 Sep 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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…)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090

Other trials in Belgium

About this study

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
Being tested: Titration procedure, Electrical impedance tomography, Lung and diaphragm ultrasound
Medical subject headings: Premature Birth, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Titration procedureDiagnostic 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.
Electrical impedance tomographyDiagnostic 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.
Lung and diaphragm ultrasoundDiagnostic 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.

Study groups in NCT05987800
Study group	Role	What they receive
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. Receives: Diagnostic Test: Titration procedure; Diagnostic Test: Electrical impedance tomography; Diagnostic Test: Lung and diaphragm ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Total duration of respiratory support
Total number of days of invasive and non-invasive respiratory support
Measured: 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
Measured: From birth until gestational age of 36 weeks

Secondary outcomes (14)

Duration of invasive respiratory support (days)
Measured: From birth until study completion, variating between 3 weeks and 3 months
Duration of non-invasive respiratory support (days)
Measured: From birth until study completion, between 3 weeks and 3 months
Description of mode of non-invasive respiratory support
Use of NIV-NAVA, CPAP, high flow nasal cannula, oxygen therapy
Measured: From birth until study completion, between 3 weeks and 3 months
Use of surfactant and mode of administration
Measured: From birth until study completion, between 3 weeks and 3 months
Incidence of nosocomial infection
Measured: From birth until study completion, between 3 weeks and 3 months
Use of corticosteroids for the prevention or treatment of BPD
Use of any corticosteroid (systemic or local)
Measured: From birth until study completion, between 3 weeks and 3 months
Length of hospital stay
Days of stay in the neonatal unit
Measured: From birth until study completion, between 3 weeks and 3 months
Respiratory severity score (RSS)
RSS will be measured during the weaning phase of non-invasive respiratory support
Measured: From start of the weaning phase until respiratory support is stopped, up to 10 weeks
NIV-NAVA breakpoint
Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol
Measured: At inclusion (within 24 hours)
Lung ultrasound score
Lung ultrasound score will be scored at several time points
Measured: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
Diaphragm ultrasound
Measurement of diaphragm thickness with ultrasound
Measured: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
Silent Spaces
Parts (in % of global lung volume) of the lung that are not ventilated as measured with electrical impedance tomography (EIT)
Measured: 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
Tidal volume (TV)
Percentage of TV per 'Region of Interest' (ROI) as measured with electrical impedance tomography (EIT)
Measured: 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
Center of Ventilation (CoV)
As measured with electrical impedance tomography (EIT)
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202330 Sep 2025

First posted14 Aug 2023
Study start1 Feb 2023
Primary completion3 Jun 2025
Study completion30 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Premature BirthStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05987800
Sponsor's protocol ID: NIV study
Status last verified: May 2026
First submitted: 2 Nov 2022
Last updated: 12 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Database on non-invasive ventilation has the potential to be shared but no concrete plan for sharing individual patient data is made.

Publications

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.
PubMed 17989387
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.
PubMed 30974433
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.
PubMed 34533644
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.
PubMed 30905442
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.
PubMed 33246967
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.
PubMed 30127522
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.
PubMed 32458563

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
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Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruitingObservational study
Effects of Transitional Circulation in ELBW Infants
Neonatal Prematurity, Hypotension

All Premature Birth trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Ventilation in Preterm Infants
ClinicalTrials.gov ID: NCT05987800
Acronym / sponsor ID: NIV study
Conditions: Premature Birth, Respiratory Distress Syndrome, Ventilator Lung; Newborn
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Universitair Ziekenhuis BrusselUniversity, hospital or other
Study start: 1 Feb 2023 (actual)
Primary completion: 3 Jun 2025 (actual)
Study completion: 30 Sep 2025 (actual)
First posted: 14 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Preterm infants on non-invasive respiratory support	Other	Diagnostic Test: Titration procedure, Diagnostic Test: Electrical impedance tomography, Diagnostic Test: Lung and diaphragm ultrasoundAll infants on non-invasive respiratory support will be studied. Only infants on less than 32 weeks of gestation at birth, will undergo an intervention.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (2 listed)

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…)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Titration procedureThe 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	Preterm infants on non-invasive respiratory support
Electrical impedance tomographyThis 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	Preterm infants on non-invasive respiratory support
Lung and diaphragm ultrasoundLung 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.	Diagnostic test	Preterm infants on non-invasive respiratory support

Primary outcome

Total duration of respiratory support
Time frame: 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
Time frame: From birth until gestational age of 36 weeks
Percentage of infants with BPD or death

14 secondary outcomes

Duration of invasive respiratory support (days)
Time frame: From birth until study completion, variating between 3 weeks and 3 months
Duration of non-invasive respiratory support (days)
Time frame: From birth until study completion, between 3 weeks and 3 months
Description of mode of non-invasive respiratory support
Time frame: From birth until study completion, between 3 weeks and 3 months
Use of surfactant and mode of administration
Time frame: From birth until study completion, between 3 weeks and 3 months
Incidence of nosocomial infection
Time frame: From birth until study completion, between 3 weeks and 3 months
Use of corticosteroids for the prevention or treatment of BPD
Time frame: From birth until study completion, between 3 weeks and 3 months
Length of hospital stay
Time frame: From birth until study completion, between 3 weeks and 3 months
Respiratory severity score (RSS)
Time frame: From start of the weaning phase until respiratory support is stopped, up to 10 weeks
NIV-NAVA breakpoint
Time frame: At inclusion (within 24 hours)
Lung ultrasound score
Time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
Diaphragm ultrasound
Time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
Silent Spaces
Time frame: 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
Tidal volume (TV)
Time frame: 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
Center of Ventilation (CoV)
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Background: PubMed 17989387Baraldi 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.
Background: PubMed 30974433Sweet 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.
Background: PubMed 34533644Lefevere 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.
Background: PubMed 30905442Harada 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.
Background: PubMed 33246967Thomson 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.
Background: PubMed 30127522Raimondi 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.
Background: PubMed 32458563Alonso-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.
Individual participant dataSharing planned: No. Database on non-invasive ventilation has the potential to be shared but no concrete plan for sharing individual patient data is made.

Related trials for Premature Birth

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Preterm, Preterm Infant Development
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julie Lefevere, MD principal investigator

Universitair Ziekenhuis Brussel

Filip Cools, PhD study director

Universitair Ziekenhuis Brussel

Brenda Van Delft, Nurse study chair

Universitair Ziekenhuis Brussel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total duration of respiratory support (time frame: From birth until study completion, variating between 3 weeks and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05987800, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.