Hernia, DIaphragmatic, CongenitalNAVA-DIAPHNCT03250793
Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in NAVA and in Conventional Ventilation.
A study testing Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer in people with Hernia, DIaphragmatic, Congenital, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Hernia, DIaphragmatic, Congenital
- What is being tested?
- Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 20 Aug 2018to 20 Jan 2021
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Neonate admitted to neonatal intensive care beyond 34 weeks of amenorrhea
- With a diagnosis of congenital diaphragmatic hernia having undergone a repair surgery.
- Necessary invasive ventilatory support by conventional ventilation
- Informed and signed consent of parents (and / or holders of parental authority)
Who cannot join
- Refusal of parents (and / or holders of parental authority) to participate in the study
- Contra-indication to the use of an oro or naso-gastric tube (oesophageal surgery)
- Child at risk of poor tolerance to the placement of the oesophageal pressure transducer (history of discomfort when placing a tube, weight <1500g)
- Central or neuromuscular neurological pathology which may affect respiratory control
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
Bron, 69500
About this study
Official title: Physiologic Pilot Study: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in Post-surgical Period Alternatively in Conventional Ventilation (Pressure Controlled) and in NAVA (Neurally Adjusted Ventilatory Assist) Ventilation.
Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a synchronized proportional assisted ventilation. This technique has already been used in the newborn, especially premature and has shown many benefits. Only one study in the literature shows its feasibility in newborns with CDH. This technique seems interesting in the context of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating the clinical benefits, it seems important to describe the effects on the respiratory physiology, in particular on work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is an innovative physiologic pilot study with the objective to describe work of breathing in neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation using an esophageal transducer. It will provide the clinician with a physiological justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of these patients. This study is a prerequisite for the realization of studies demonstrating the clinical benefit of NAVA ventilation on reduction of duration of ventilation and more generally on morbidity and mortality in the population of neonate with CDH.
- Conditions
- Hernia, DIaphragmatic, Congenital
- Being tested
- Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
- Keywords
- Hernia, DIaphragmatic, Congenital, Respiration, Artificial, physiologic pilot study, NAVA, Neurally Adjusted Ventilatory Assist, esophageal transducer, Work of Breathing
- Medical subject headings
- Hernia, Diaphragmatic, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducerDevice
While the patient is under respiratory assistance on the SERVO-I respirator, he will be included in the study and one esophageal transducer of 2,3 mm of diameter will be inserted through the mouth / nose in addition to NAVA's naso / Oro-Gastric tube( Edi Catheter, 6Fr, 49 cm, PHT free 5 pcs / pkg or Catheter Edi, 6Fr, 50 cm, PHT free 5 pcs / pkg). Measurements will be performed using the esophageal transducer under two conditions: 2 hours in conventional ventilation (pressure controlled), 2 hours in NAVA ventilation and then again 2 hours in conventional ventilation (PC) for a total duration of 6 hours.The parameters of conventional ventilation will be left free at the choice of the neonatologist and will be identical between the two periods of conventional ventilation. The initial NAVA level will be defined by the neonatologist using pre-visualization curves. All signals will be recorded via an amplification and acquisition system. Values will be averaged over 100 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Neonate with congenital diaphragmatic hernia | Experimental | Neonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation Receives: Device: Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
Measured: in post-surgical period during 6 hours
Secondary outcomes (30)
Patient-ventilator synchronization in NAVA
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Measured: through study completion, an average of 1 year
Patient-ventilator synchronization in conventional ventilation
Comparison of the asynchrony indexes between the 2 modes (Number of asynchronies / Number of respiratory cycles)
Measured: through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in NAVA
Intrinsic PEEP average over 100 cycles
Measured: through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
Intrinsic PEEP average over 100 cycles
Measured: through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: mean pressure in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: tidal volume in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: FiO2 in NAVA
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: mean pressure in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: tidal volume in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Ventilation parameters: FiO2 in conventional ventilation
Evolution of the following parameters: peak inspiratory pressure, mean pressure, tidal volume, Ti / Ttot ration, FiO2
Measured: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Measured: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Measured: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Measured: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation
Averages of the esophageal and diaphragmatic swings over 100 cycles in each period. Esophageal and diaphragmatic swings are physiological parameters obtained by the esophageal transducer which expressed muscle strength.
Measured: through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in NAVA
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in NAVA
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in NAVA
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in conventional ventilation
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in conventional ventilation
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in conventional ventilation
Evolution of clinical parameters (respiratory rate, heart rate, blood pressure) at the beginning and end of each period
Measured: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in NAVA
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Measured: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in NAVA
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Measured: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Measured: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation
Evolution of oxygenation parameters (SpO2) and transcutaneous CO2 (pCO2) during each period. SpO2 and pCO2 are measured continuously; average and median will be valued in each period of the study. No blood test will be required.
Measured: through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
Measured: through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation
Evaluation of comfort (COMFORT-BEHAVIOR scale) at the beginning and at the end of each period.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start20 Aug 2018
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
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 Hernia, DIaphragmatic, CongenitalStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lélia Dreyfus, MD, Principal investigator, Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250793
- Sponsor's protocol ID
- 69HCL17_0429
- Other IDs
- 2017-A02270-53
- Acronym
- NAVA-DIAPH
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2017
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dreyfus L, Butin M, Plaisant F, Claris O, Baudin F. Respiratory physiology during NAVA ventilation in neonates born with a congenital diaphragmatic hernia: The "NAVA-diaph" pilot study. Pediatr Pulmonol. 2023 May;58(5):1542-1550. doi: 10.1002/ppul.26357. Epub 2023 Mar 1.
PubMed 36807570
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Pilot Study: Work of Breathing Description in Neonates With Congenital Diaphragmatic Hernia in Post-surgical Period Alternatively in Conventional Ventilation (Pressure Controlled) and in NAVA (Neurally Adjusted Ventilatory Assist) Ventilation.
- ClinicalTrials.gov ID
- NCT03250793
- Acronym / sponsor ID
- NAVA-DIAPH / 69HCL17_0429
- Conditions
- Hernia, DIaphragmatic, Congenital
- Keywords
- Hernia, DIaphragmatic, Congenital, Respiration, Artificial, physiologic pilot study, NAVA, Neurally Adjusted Ventilatory Assist, esophageal transducer, Work of Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 16 Aug 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.
Congenital diaphragmatic hernia (CDH) is a congenital malformation associated with significant mortality and respiratory morbidity, particularly related to prolonged mechanical ventilation. NAVA (Neurally Adjusted Ventilatory Assist) is a recent technique that uses the recognition of the electrical activity of the patient's diaphragm (Edi) and delivers a synchronized proportional assisted ventilation. This technique has already been used in the newborn, especially premature and has shown many benefits. Only one study in the literature shows its feasibility in newborns with CDH. This technique seems interesting in the context of CDH because it would limit baro-trauma and improve synchronization. Before demonstrating the clinical benefits, it seems important to describe the effects on the respiratory physiology, in particular on work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer. Our study is an innovative physiologic pilot study with the objective to describe work of breathing in neonates with CDH in post-surgical period in NAVA ventilation and in conventional ventilation using an esophageal transducer. It will provide the clinician with a physiological justification for the use of NAVA to rapidly improve the respiratory muscular dynamics of these patients. This study is a prerequisite for the realization of studies demonstrating the clinical benefit of NAVA ventilation on reduction of duration of ventilation and more generally on morbidity and mortality in the population of neonate with CDH.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonate with congenital diaphragmatic hernia | Experimental | Device: Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducerNeonates with congenital diaphragmatic hernia in post-surgical period under mechanical ventilation during weaning of mechanical ventilation |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Neonate admitted to neonatal intensive care beyond 34 weeks of amenorrhea
- With a diagnosis of congenital diaphragmatic hernia having undergone a repair surgery.
- Necessary invasive ventilatory support by conventional ventilation
- Informed and signed consent of parents (and / or holders of parental authority)
Key exclusion criteria (4 listed)
- Refusal of parents (and / or holders of parental authority) to participate in the study
- Contra-indication to the use of an oro or naso-gastric tube (oesophageal surgery)
- Child at risk of poor tolerance to the placement of the oesophageal pressure transducer (history of discomfort when placing a tube, weight <1500g)
- Central or neuromuscular neurological pathology which may affect respiratory control
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 |
|---|---|---|
| Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducerWhile the patient is under respiratory assistance on the SERVO-I respirator, he will be included in the study and one esophageal transducer of 2,3 mm of diameter will be inserted through the mouth / nose in addition to NAVA's naso / Oro-Gastric tube( Edi Catheter, 6Fr, 49 cm, PHT free 5 pcs / pkg or Catheter Edi, 6Fr, 50 cm, PHT free 5 pcs / pkg). Measurements will be performed using the esophageal transducer under two conditions: 2 hours in conventional ventilation (pressure controlled), 2 hours in NAVA ventilation and then again 2 hours in conventional ventilation (PC) for a total duration of 6 hours.The parameters of conventional ventilation will be left free at the choice of the neonatologist and will be identical between the two periods of conventional ventilation. The initial NAVA level will be defined by the neonatologist using pre-visualization curves. All signals will be recorded via an amplification and acquisition system. Values will be averaged over 100 cycles. | Device | Neonate with congenital diaphragmatic hernia |
Primary outcome
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation
Time frame: in post-surgical period during 6 hours
Work of breathing is estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer
30 secondary outcomes
Patient-ventilator synchronization in NAVA
Time frame: through study completion, an average of 1 year
Patient-ventilator synchronization in conventional ventilation
Time frame: through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in NAVA
Time frame: through study completion, an average of 1 year
Dynamic hyperinflation (intrinsic PEEP) in conventional ventilation.
Time frame: through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in NAVA
Time frame: through study completion, an average of 1 year
Ventilation parameters: mean pressure in NAVA
Time frame: through study completion, an average of 1 year
Ventilation parameters: tidal volume in NAVA
Time frame: through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in NAVA
Time frame: through study completion, an average of 1 year
Ventilation parameters: FiO2 in NAVA
Time frame: through study completion, an average of 1 year
Ventilation parameters: peak inspiratory pressure in conventional ventilation
Time frame: through study completion, an average of 1 year
Ventilation parameters: mean pressure in conventional ventilation
Time frame: through study completion, an average of 1 year
Ventilation parameters: tidal volume in conventional ventilation
Time frame: through study completion, an average of 1 year
Ventilation parameters: Ti / Ttot ratio in conventional ventilation
Time frame: through study completion, an average of 1 year
Ventilation parameters: FiO2 in conventional ventilation
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in NAVA
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in NAVA
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: esophageal swing in conventional ventilation
Time frame: through study completion, an average of 1 year
Physiological parameters indirectly evaluating work of breathing: diaphragmatic swing in conventional ventilation
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in NAVA
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in NAVA
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in NAVA
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: respiratory rate in conventional ventilation
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: heart rate in conventional ventilation
Time frame: through study completion, an average of 1 year
Clinical parameters of neonates: blood pressure in conventional ventilation
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in NAVA
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in NAVA
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous pCO2 in conventional ventilation
Time frame: through study completion, an average of 1 year
Gas exchange: measurement of transcutaneous SaO2 in conventional ventilation
Time frame: through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in NAVA
Time frame: through study completion, an average of 1 year
Neonate comfort scores: COMFORT-BEHAVIOR score in conventional ventilation
Time frame: through study completion, an average of 1 year
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 4 Sep 2025.
- Results publication: PubMed 36807570Dreyfus L, Butin M, Plaisant F, Claris O, Baudin F. Respiratory physiology during NAVA ventilation in neonates born with a congenital diaphragmatic hernia: The "NAVA-diaph" pilot study. Pediatr Pulmonol. 2023 May;58(5):1542-1550. doi: 10.1002/ppul.26357. Epub 2023 Mar 1.
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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.
Lélia Dreyfus, MD principal investigator
Service de Réanimation Néonatale- Hôpital Femme Mère Enfant- Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer in people with Hernia, DIaphragmatic, Congenital, run by Hospices Civils de Lyon 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 4 inclusion and 4 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 4 Sep 2025. 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?
Work of breathing averaged over 100 consecutive cycles in NAVA ventilation and conventional ventilation (time frame: in post-surgical period during 6 hours). 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 NCT03250793, 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 4 Sep 2025.