Respiratory Distress Syndrome, NewbornHFPVNCT00556738
Intrapulmonary Percussive Ventilation (IPV) Versus Nasal Continuous Positive Airway Pressure Ventilation (nCPAP) in Transient Respiratory Distress of the Newborn
A study testing Nasal Continuous Positive Airway Pressure ventilation and Intrapulmonary Percussive Ventilation in people with Respiratory Distress Syndrome, Newborn, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Nasal Continuous Positive Airway Pressure ventilation and Intrapulmonary Percussive Ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2007to Dec 2009
- 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
- Caesarean newborn
- Gestational age ≥ 35 weeks
- Weight ≥ 2 kg
- SaO2 < 90% after 10 min of life
- Silverman score ≥ 5
- Treated less than 20 min after birth
- Social security affiliation (parents)
- Informed consent signed (parents)
Who cannot join
- Thoracic retraction
- Congenital intrathoracic malformations
- Meconium aspiration
- Early neonatal infections with hemodynamic troubles
- Severe neonatal asphyxia
- Polymalformative syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies
Read the detailed description
- Principal Objective: To show that IPV ventilation can decrease the duration of transient respiratory distress as well as the risk of complications.
- Secondary Objective: Comparison between the two groups regarding: Length of oxygen therapy, complications (pneumothorax, pulmonary infections), need for intensive care hospitalization
- Study design: Open, prospective randomized trial.
- Inclusion criteria: Neonates with gestational age ≥ 35 weeks and weight ≥ 2000g, caesarean section, respiratory distress syndrome (modified Silverman score > 5, SpO2 < 90%), management within 20 minutes after birth.
- Exclusion criteria: clinical thoracic retraction, congenital lung malformation, meconium aspiration, neonatal infection, other congenital malformations.
- Study plan: After the screening evaluation and written consent document, neonates will be randomized into two groups: nCPAP ventilation or IPV. During the 6 hours after randomization, clinical data will be monitored: cardiac and respiratory frequency (CF -RF), saturation (SaO2), oxygenotherapy, Silverman Score. Then, neonates will be supervised 3 days after normalization of the respiratory distress.
- Number of subjects: 100 (50 in each group)
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Nasal Continuous Positive Airway Pressure ventilation, Intrapulmonary Percussive Ventilation
- Keywords
- HFPV, neonatal respiratory distress
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Continuous Positive Airway Pressure ventilationProcedure or surgery
Nasal Continuous Positive Airway Pressure ventilation
Intrapulmonary Percussive VentilationProcedure or surgery
Intrapulmonary Percussive Ventilation
| Study group | Role | What they receive |
|---|---|---|
| nHFPV | Experimental | Intrapulmonary Percussive Ventilation Receives: Procedure: Intrapulmonary Percussive Ventilation |
| nCPAP | Active comparator | Nasal Continuous Positive Airway Pressure ventilation Receives: Procedure: Nasal Continuous Positive Airway Pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes
Measured: Within the first 6 hours after birth
Secondary outcomes (1)
Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy
Measured: Within the first 72 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionDec 2009
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 Respiratory Distress Syndrome, NewbornStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Investigators
- Clothilde Bertrand, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556738
- Sponsor's protocol ID
- CHUBX 2007/09
- Other IDs
- 2007-A00666-47
- Acronym
- HFPV
- Status last verified
- May 2010
- First submitted
- 9 Nov 2007
- Last updated
- 13 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dumas De La Roque E, Bertrand C, Tandonnet O, Rebola M, Roquand E, Renesme L, Elleau C. Nasal high frequency percussive ventilation versus nasal continuous positive airway pressure in transient tachypnea of the newborn: a pilot randomized controlled trial (NCT00556738). Pediatr Pulmonol. 2011 Mar;46(3):218-23. doi: 10.1002/ppul.21354. Epub 2010 Oct 20.
PubMed 20963833
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapulmonary Percussive Ventilation and Nasal Continuous Positive Airway Pressure Ventilation in Transient Respiratory Distress of the Newborn: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00556738
- Acronym / sponsor ID
- HFPV / CHUBX 2007/09
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- HFPV, neonatal respiratory distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Nov 2007 (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.
During caesarean section, transient respiratory distress which occurs frequently (3%) with possible complications are at present managed by non invasive nasal continuous positive airway pressure ventilation (nCPAP) associated with oxygen therapy. Intrapulmonary Percussive Ventilation (IPV) is a non-invasive ventilatory mode used in some intensive care units to treat some respiratory distress syndrome of the newborn with a good tolerance, but without evaluation in prospective studies
Detailed description
- Principal Objective: To show that IPV ventilation can decrease the duration of transient respiratory distress as well as the risk of complications.
- Secondary Objective: Comparison between the two groups regarding: Length of oxygen therapy, complications (pneumothorax, pulmonary infections), need for intensive care hospitalization
- Study design: Open, prospective randomized trial.
- Inclusion criteria: Neonates with gestational age ≥ 35 weeks and weight ≥ 2000g, caesarean section, respiratory distress syndrome (modified Silverman score > 5, SpO2 < 90%), management within 20 minutes after birth.
- Exclusion criteria: clinical thoracic retraction, congenital lung malformation, meconium aspiration, neonatal infection, other congenital malformations.
- Study plan: After the screening evaluation and written consent document, neonates will be randomized into two groups: nCPAP ventilation or IPV. During the 6 hours after randomization, clinical data will be monitored: cardiac and respiratory frequency (CF -RF), saturation (SaO2), oxygenotherapy, Silverman Score. Then, neonates will be supervised 3 days after normalization of the respiratory distress.
- Number of subjects: 100 (50 in each group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nHFPV | Experimental | Procedure: Intrapulmonary Percussive VentilationIntrapulmonary Percussive Ventilation |
| nCPAP | Active comparator | Procedure: Nasal Continuous Positive Airway Pressure ventilationNasal Continuous Positive Airway Pressure ventilation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Caesarean newborn
- Gestational age ≥ 35 weeks
- Weight ≥ 2 kg
- SaO2 < 90% after 10 min of life
- Silverman score ≥ 5
Key exclusion criteria (6 listed)
- Thoracic retraction
- Congenital intrathoracic malformations
- Meconium aspiration
- Early neonatal infections with hemodynamic troubles
- Severe neonatal asphyxia
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 Positive Airway Pressure ventilationNasal Continuous Positive Airway Pressure ventilation | Procedure or surgery | nCPAP |
| Intrapulmonary Percussive VentilationIntrapulmonary Percussive Ventilation | Procedure or surgery | nHFPV |
Primary outcome
Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes
Time frame: Within the first 6 hours after birth
1 secondary outcome
Number of pneumothorax, lung infections, transfer to intensive care service, time of oxygenotherapy
Time frame: Within the first 72 hours after birth
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 13 May 2010.
- Derived from this study: PubMed 20963833Dumas De La Roque E, Bertrand C, Tandonnet O, Rebola M, Roquand E, Renesme L, Elleau C. Nasal high frequency percussive ventilation versus nasal continuous positive airway pressure in transient tachypnea of the newborn: a pilot randomized controlled trial (NCT00556738). Pediatr Pulmonol. 2011 Mar;46(3):218-23. doi: 10.1002/ppul.21354. Epub 2010 Oct 20.
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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.
Clothilde Bertrand, Dr principal investigator
University Hospital, Bordeaux
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 Positive Airway Pressure ventilation and Intrapulmonary Percussive Ventilation in people with Respiratory Distress Syndrome, Newborn, 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 8 inclusion and 6 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 13 May 2010. 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?
Difference in time (min) required to normalize the respiratory distress (modified Silverman score = 0, no need for oxygen, RF < 50 bpm and SaO2 > 92%) between the two ventilatory modes (time frame: Within the first 6 hours after birth). 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 NCT00556738, 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 13 May 2010.