Neonatal Respiratory DistressTONIPEPNCT02030691
Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress
A study testing Nasal continuous airway positive pressure (nCPAP) and Nasal high frequency percussive ventilation (nHFPV) in people with Neonatal Respiratory Distress, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages Up to 30 minutes
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- Nasal continuous airway positive pressure (nCPAP) and Nasal high frequency percussive ventilation (nHFPV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to 7 Nov 2016
- 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 30 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn neonate.
- Delivered by vaginal delivery or caesarean section.
- Gestational age greater than or equal to 33 weeks of gestation.
- Birth weight > 1kg.
- Respiratory distress with a Silverman score greater than or equal to 4 after 10 minutes of life.
- Signed parental informed consent.
Who cannot join
- Meconium aspiration syndrome.
- Congenital anomalies such as heart anomalies, congenital cystic adenomatoid malformation, diaphragmatic hernia…
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Néonatalogie - Maternité - Hôpital Pellegrin
Bordeaux, Bordeaux, 33076
About this study
Official title: Tolerance of Nasal High Frequency Percussive Ventilation Versus Nasal CPAP in Neonatal Respiratory Distress in Term and Preterm (> 33 Weeks of Gestation) Neonates
Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.
We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).
Read the detailed description
The objective is to compare nHFPV versus nCPAP tolerance for providing PEEP in newborn respiratory distress.
High frequency percussive ventilation (HFPV) is a pressure limited, time-cycled, high-frequency mode of ventilation that delivers subphysiologic tidal volumes at rapid rates and that can be used via an endotracheal tube, a nasal probe or a face mask. In burned children, it has been shown to provide the same or improved oxygenation and ventilation at lower peak pressure when compared with conventional ventilation. In neonates, HFPV has been described in hyaline membrane disease and acute respiratory failure ventilation with improvement in oxygenation, significant decrease in PaCO2 and no change in central hemodynamics and we recently shown that nasal HFPV is more effective than nasal continuous positive airway pressure in transient tachypnea of the newborn. This stud is a cross-over clinical trial. For each patient enrolled, the 2 respiratory devices (nHFPV and nCPAP) were used one after the other for 15 minutes each. Randomization determines which device to use in first (group A nCPAP then nHFPV, group B (nHFPV then nCPAP). During the experiment, rSO2c is continuously recorded by NIRS, and oxygenation and capnia are monitored in a non invasive way by transcutaneous oxygen saturation and transcutaneous capnia measurement. Ventilators' setting (PEEP, FiO2) will be modified to achieve oxygen and capnia targets (SpO2 > 90%, and under 95% if FiO2>0.21, Capnia between 5 to 7 kPa). Duration of patient follow up is 30 minutes. After these 30 minutes, if PEEP is always needed, patients undergo nCPAP. If needed during the experiment, patients can receive mechanical ventilation (the criteria for mechanical ventilation are the same as those used in clinical practice).
- Conditions
- Neonatal Respiratory Distress
- Being tested
- Nasal continuous airway positive pressure (nCPAP), Nasal high frequency percussive ventilation (nHFPV)
- Keywords
- Neonatal respiratory distress, nHFPV, nCPAP, cerebral tissue oxygenation, NIRS
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal continuous airway positive pressure (nCPAP)Device
Nasal high frequency percussive ventilation (nHFPV)Device
| Study group | Role | What they receive |
|---|---|---|
| nCPAP - nHFPV | Experimental | Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required. Receives: Device: Nasal continuous airway positive pressure (nCPAP); Device: Nasal high frequency percussive ventilation (nHFPV) |
| nHFPV - nCPAP | Experimental | Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required. Receives: Device: Nasal continuous airway positive pressure (nCPAP); Device: Nasal high frequency percussive ventilation (nHFPV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of cerebral tissue oxygenation (rSO2c) by near infrared spectroscopy (NIRS). We compared the mean of the variation of rSO2c during the last 5 minutes for each device (nHFPV and nCPAP).
Measured: 30 minutes after the inclusion
Secondary outcomes (1)
Measurement of transcutaneous capnia and oxygen saturation; variation of heart rate, breath rate and blood pressure; ventilators' setting (PEEP, FiO2).
Measured: 30 minutes after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startMay 2014
- Primary completion7 Nov 2016
- Study completion7 Nov 2016
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 Neonatal Respiratory DistressStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent RENESME, MD, Principal investigator, University Hospital Bordeaux, FranceAntoine BENARD, MD, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030691
- Sponsor's protocol ID
- CHUBX 2013/10
- Other IDs
- 2013-A01399-36
- Acronym
- TONIPEP
- Status last verified
- Jul 2017
- First submitted
- 7 Jan 2014
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Renesme L, Dumas de la Roque E, Germain C, Chevrier A, Rebola M, Cramaregeas S, Benard A, Elleau C, Tandonnet O. Nasal high-frequency percussive ventilation vs nasal continuous positive airway pressure in newborn infants respiratory distress: A cross over clinical trial. Pediatr Pulmonol. 2020 Oct;55(10):2617-2623. doi: 10.1002/ppul.24935. Epub 2020 Jul 10.
PubMed 32609946
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Nasal High Frequency Percussive Ventilation Versus Nasal CPAP in Neonatal Respiratory Distress in Term and Preterm (> 33 Weeks of Gestation) Neonates
- ClinicalTrials.gov ID
- NCT02030691
- Acronym / sponsor ID
- TONIPEP / CHUBX 2013/10
- Conditions
- Neonatal Respiratory Distress
- Keywords
- Neonatal respiratory distress, nHFPV, nCPAP, cerebral tissue oxygenation, NIRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 7 Nov 2016 (actual)
- Study completion
- 7 Nov 2016 (actual)
- First posted
- 8 Jan 2014 (estimated)
- 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.
Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.
We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).
Detailed description
The objective is to compare nHFPV versus nCPAP tolerance for providing PEEP in newborn respiratory distress.
High frequency percussive ventilation (HFPV) is a pressure limited, time-cycled, high-frequency mode of ventilation that delivers subphysiologic tidal volumes at rapid rates and that can be used via an endotracheal tube, a nasal probe or a face mask. In burned children, it has been shown to provide the same or improved oxygenation and ventilation at lower peak pressure when compared with conventional ventilation. In neonates, HFPV has been described in hyaline membrane disease and acute respiratory failure ventilation with improvement in oxygenation, significant decrease in PaCO2 and no change in central hemodynamics and we recently shown that nasal HFPV is more effective than nasal continuous positive airway pressure in transient tachypnea of the newborn. This stud is a cross-over clinical trial. For each patient enrolled, the 2 respiratory devices (nHFPV and nCPAP) were used one after the other for 15 minutes each. Randomization determines which device to use in first (group A nCPAP then nHFPV, group B (nHFPV then nCPAP). During the experiment, rSO2c is continuously recorded by NIRS, and oxygenation and capnia are monitored in a non invasive way by transcutaneous oxygen saturation and transcutaneous capnia measurement. Ventilators' setting (PEEP, FiO2) will be modified to achieve oxygen and capnia targets (SpO2 > 90%, and under 95% if FiO2>0.21, Capnia between 5 to 7 kPa). Duration of patient follow up is 30 minutes. After these 30 minutes, if PEEP is always needed, patients undergo nCPAP. If needed during the experiment, patients can receive mechanical ventilation (the criteria for mechanical ventilation are the same as those used in clinical practice).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nCPAP - nHFPV | Experimental | Device: Nasal continuous airway positive pressure (nCPAP), Device: Nasal high frequency percussive ventilation (nHFPV)Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required. |
| nHFPV - nCPAP | Experimental | Device: Nasal continuous airway positive pressure (nCPAP), Device: Nasal high frequency percussive ventilation (nHFPV)Eligible patient received after randomization nCPAP or nHFPV for 15 minutes then after the 15 minutes, they received the seconde non invasive device for 15 minutes. Study end 30 minutes after randomization or before if mechanical ventilation is required. |
Who may qualify
- Ages
- Up to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Inborn neonate.
- Delivered by vaginal delivery or caesarean section.
- Gestational age greater than or equal to 33 weeks of gestation.
- Birth weight > 1kg.
- Respiratory distress with a Silverman score greater than or equal to 4 after 10 minutes of life.
Key exclusion criteria (2 listed)
- Meconium aspiration syndrome.
- Congenital anomalies such as heart anomalies, congenital cystic adenomatoid malformation, 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 |
|---|---|---|
| Nasal continuous airway positive pressure (nCPAP) | Device | nCPAP - nHFPV, nHFPV - nCPAP |
| Nasal high frequency percussive ventilation (nHFPV) | Device | nCPAP - nHFPV, nHFPV - nCPAP |
Primary outcome
Measurement of cerebral tissue oxygenation (rSO2c) by near infrared spectroscopy (NIRS). We compared the mean of the variation of rSO2c during the last 5 minutes for each device (nHFPV and nCPAP).
Time frame: 30 minutes after the inclusion
1 secondary outcome
Measurement of transcutaneous capnia and oxygen saturation; variation of heart rate, breath rate and blood pressure; ventilators' setting (PEEP, FiO2).
Time frame: 30 minutes after the inclusion
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 18 Jun 2026.
- Results publication: PubMed 32609946Renesme L, Dumas de la Roque E, Germain C, Chevrier A, Rebola M, Cramaregeas S, Benard A, Elleau C, Tandonnet O. Nasal high-frequency percussive ventilation vs nasal continuous positive airway pressure in newborn infants respiratory distress: A cross over clinical trial. Pediatr Pulmonol. 2020 Oct;55(10):2617-2623. doi: 10.1002/ppul.24935. Epub 2020 Jul 10.
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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.
Laurent RENESME, MD principal investigator
University Hospital Bordeaux, France
Antoine BENARD, MD study chair
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal continuous airway positive pressure (nCPAP) and Nasal high frequency percussive ventilation (nHFPV) in people with Neonatal Respiratory Distress, run by University Hospital, Bordeaux 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 6 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 18 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 cerebral tissue oxygenation (rSO2c) by near infrared spectroscopy (NIRS). We compared the mean of the variation of rSO2c during the last 5 minutes for each device (nHFPV and nCPAP). (time frame: 30 minutes after the inclusion). 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 NCT02030691, 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 18 Jun 2026.