BronchiolitisDEBIBNCT03298217
Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis
A study testing Measurement of the peak tidal inspiratory flow (PTIF) in people with Bronchiolitis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB). PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Measurement of the peak tidal inspiratory flow (PTIF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2017to 16 Jan 2019
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants up to 6 months old, with AVB according to conventional clinical criteria;
- Admitted to the department of Neonatal and Pediatric Intensive Care at Arnaud de Villeneuve University Hospital in Montpellier (France);
- Supported with HFNC, according to the department's protocol (2 < m-WCAS < 5);
- Not requiring immediate intubation for invasive ventilation;
- Signed parental consent.
Who cannot join
- Infant with heart disease, cystic fibrosis or neuromuscular disorder;
- Infant requiring ventilatory support with nasal continuous positive pressure (nCPAP) or with HFNC and without possibility of weaning, including for a few minutes;
- Intolerance of the spirometry mask.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study
This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).
PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.
Read the detailed description
HFNC allows the administration of a heated and humidified mixture of air and oxygen at high flows. This device has been widely adopted in pediatric intensive care units (PICUs) and for interhospital transport of critically ill children, as the system is easily set up and is well tolerated by patients. In the context of AVB, retrospective audits and observational studies have suggested promising outcomes on both physiological and clinical variables. However, in less than 6 months old infants with moderate to severe AVB, the failure rate with this device - defined as worsening of respiratory failure or the occurrence of discomfort or severe apnea - remains high, from 30% to 50% in key studies.
HFNC flow setting remains empiric, 2 L/kg/min being used by most teams. A potential explanation for this high failure rate is that the flow usually used is lower than the patient's inspiratory flow. The aim of this study is to determine peak tidal inspiratory flow (PTIF) values in infants up to 6 months old with moderate to severe AVB.
PTIF will be evaluated with a spirometer connected to a face mask during 20 cycles of spontaneous ventilation. The measurements will be performed within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care of Arnaud de Villeneuve University Hospital at Montpellier (France).
Statistical analysis Relation between the DIP and Silverman score, mWCAS, RR, LOS will be expressed with parametric and non-parametric correlation coefficients according to the distribution of the data.
- Conditions
- Bronchiolitis
- Being tested
- Measurement of the peak tidal inspiratory flow (PTIF)
- Keywords
- Inspiratory flow, High flow nasal cannula, spirometry, spirometry, physiologic study, Bronchiolitis patients sverity score mWCAS/ 3-5.
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of the peak tidal inspiratory flow (PTIF)Device
In patients with bronchiolitis sverity mWCAS / 3-5 :
Nasopharyngeal aspiration and comfortable placement of the infant upon admission; Clinical evaluation: respiratory rate, respiratory distress scores rating (Silverman and m-WCAS); If the patient is eligible: information and collection of parental consent; If signed parental consent obtained: progressive (on at least 10 min) withdrawal of HFNC support and maintenance if necessary of conventional oxygen therapy (maximum 1 L/min); Application of the spirometer for the recording of 20 consecutive spontaneous respiratory cycles for PTIF measurements; Respiratory support with HFNC; flow adapted to the need of the patients (equal to the measured PTIF).
| Study group | Role | What they receive |
|---|---|---|
| Bronchiolitis patients sverity | Other | In patients with bronchiolitis mWCAS / 3-5 : Measurement of the peak tidal inspiratory flow (PTIF) Receives: Device: Measurement of the peak tidal inspiratory flow (PTIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)
Measurement of peak or peak inspiratory flow will be performed by spirometry using a spirometer within 24 hours of patient admission. Evaluation will take place within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care among patients with moderate to severe AVB.
Description: Application of the spirometer for the recording of 20 consecutives spontaneous respiratory cycles for PTIF (l/kg/min) measurements.
Primary outcome: average (+/-SD) of 20 consecutives PTIF.
Measured: 1 day but within 24 hours of patient admission
Secondary outcomes (6)
Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
Measured: 1 day but within 24 hours of patient admission
Correlation between PTIF and Silverman score
Correlation between PTIF (l/kg/min) and Silverman score (0 to 10)
Measured: 1 day but within 24 hours of patient admission
Correlation between PTIF and modified Wood's clinical asthma score
Correlation between PTIF (l/kg/min) and modified Wood's clinical asthma score(m-WCAS) (0 to 10)
- Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)
- Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes, duration of hospitalization
Measured: 1 day but within 24 hours of patient admission
Correlation between PTIF and respiratory rate (FR)
Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)
Measured: 1 day but within 24 hours of patient admission
Correlation between PTIF and carbon dioxide (CO2)
Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes
Measured: 1 day
Duration of hospitalization
Duration of hospitalization
Measured: 1 day at the end of the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start21 Nov 2017
- Primary completion16 Jan 2019
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe MILESI, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298217
- Sponsor's protocol ID
- UF9868
- Acronym
- DEBIB
- Status last verified
- May 2026
- First submitted
- 19 Jul 2017
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Milesi C, Requirand A, Douillard A, Baleine J, Nogue E, Matecki S, Amedro P, Pons-Odena M, Cambonie G. Assessment of Peak Inspiratory Flow in Young Infants with Acute Viral Bronchiolitis: Physiological Basis for Initial Flow Setting in Patients Supported with High-Flow Nasal Cannula. J Pediatr. 2021 Apr;231:239-245.e1. doi: 10.1016/j.jpeds.2020.12.020. Epub 2020 Dec 15.
PubMed 33333115
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study
- ClinicalTrials.gov ID
- NCT03298217
- Acronym / sponsor ID
- DEBIB / UF9868
- Conditions
- Bronchiolitis
- Keywords
- Inspiratory flow, High flow nasal cannula, spirometry, spirometry, physiologic study, Bronchiolitis patients sverity score mWCAS/ 3-5.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 16 Jan 2019 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 2 Oct 2017 (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.
This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).
PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.
Detailed description
HFNC allows the administration of a heated and humidified mixture of air and oxygen at high flows. This device has been widely adopted in pediatric intensive care units (PICUs) and for interhospital transport of critically ill children, as the system is easily set up and is well tolerated by patients. In the context of AVB, retrospective audits and observational studies have suggested promising outcomes on both physiological and clinical variables. However, in less than 6 months old infants with moderate to severe AVB, the failure rate with this device - defined as worsening of respiratory failure or the occurrence of discomfort or severe apnea - remains high, from 30% to 50% in key studies.
HFNC flow setting remains empiric, 2 L/kg/min being used by most teams. A potential explanation for this high failure rate is that the flow usually used is lower than the patient's inspiratory flow. The aim of this study is to determine peak tidal inspiratory flow (PTIF) values in infants up to 6 months old with moderate to severe AVB.
PTIF will be evaluated with a spirometer connected to a face mask during 20 cycles of spontaneous ventilation. The measurements will be performed within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care of Arnaud de Villeneuve University Hospital at Montpellier (France).
Statistical analysis Relation between the DIP and Silverman score, mWCAS, RR, LOS will be expressed with parametric and non-parametric correlation coefficients according to the distribution of the data.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchiolitis patients sverity | Other | Device: Measurement of the peak tidal inspiratory flow (PTIF)In patients with bronchiolitis mWCAS / 3-5 : Measurement of the peak tidal inspiratory flow (PTIF) |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants up to 6 months old, with AVB according to conventional clinical criteria;
- Admitted to the department of Neonatal and Pediatric Intensive Care at Arnaud de Villeneuve University Hospital in Montpellier (France);
- Supported with HFNC, according to the department's protocol (2 < m-WCAS < 5);
- Not requiring immediate intubation for invasive ventilation;
- Signed parental consent.
Key exclusion criteria (3 listed)
- Infant with heart disease, cystic fibrosis or neuromuscular disorder;
- Infant requiring ventilatory support with nasal continuous positive pressure (nCPAP) or with HFNC and without possibility of weaning, including for a few minutes;
- Intolerance of the spirometry mask.
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 |
|---|---|---|
| Measurement of the peak tidal inspiratory flow (PTIF)In patients with bronchiolitis sverity mWCAS / 3-5 : Nasopharyngeal aspiration and comfortable placement of the infant upon admission; Clinical evaluation: respiratory rate, respiratory distress scores rating (Silverman and m-WCAS); If the patient is eligible: information and collection of parental consent; If signed parental consent obtained: progressive (on at least 10 min) withdrawal of HFNC support and maintenance if necessary of conventional oxygen therapy (maximum 1 L/min); Application of the spirometer for the recording of 20 consecutive spontaneous respiratory cycles for PTIF measurements; Respiratory support with HFNC; flow adapted to the need of the patients (equal to the measured PTIF). | Device | Bronchiolitis patients sverity |
Primary outcome
Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)
Time frame: 1 day but within 24 hours of patient admission
Measurement of peak or peak inspiratory flow will be performed by spirometry using a spirometer within 24 hours of patient admission. Evaluation will take place within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care among patients with moderate to severe AVB. Description: Application of the spirometer for the recording of 20 consecutives spontaneous respiratory cycles for PTIF (l/kg/min) measurements. Primary outcome: average (+/-SD) of 20 consecutives PTIF.
6 secondary outcomes
Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
Time frame: 1 day but within 24 hours of patient admission
Correlation between PTIF and Silverman score
Time frame: 1 day but within 24 hours of patient admission
Correlation between PTIF and modified Wood's clinical asthma score
Time frame: 1 day but within 24 hours of patient admission
Correlation between PTIF and respiratory rate (FR)
Time frame: 1 day but within 24 hours of patient admission
Correlation between PTIF and carbon dioxide (CO2)
Time frame: 1 day
Duration of hospitalization
Time frame: 1 day at the end of the hospitalization
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 2 Jun 2026.
- Results publication: PubMed 33333115Milesi C, Requirand A, Douillard A, Baleine J, Nogue E, Matecki S, Amedro P, Pons-Odena M, Cambonie G. Assessment of Peak Inspiratory Flow in Young Infants with Acute Viral Bronchiolitis: Physiological Basis for Initial Flow Setting in Patients Supported with High-Flow Nasal Cannula. J Pediatr. 2021 Apr;231:239-245.e1. doi: 10.1016/j.jpeds.2020.12.020. Epub 2020 Dec 15.
- Individual participant dataSharing planned: Undecided. NC
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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.
Christophe MILESI, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of the peak tidal inspiratory flow (PTIF) in people with Bronchiolitis, run by University Hospital, Montpellier at 1 site in France.
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 5 inclusion and 3 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 2 Jun 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 France. 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?
Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow) (time frame: 1 day but within 24 hours of patient admission). 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 NCT03298217, which also lists 1 linked publication.
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 2 Jun 2026.