Congenital Diaphragmatic HerniaNAN-CNCT05839340
Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
A study testing Neurally Adjusted Ventilatory Assist in people with Congenital Diaphragmatic Hernia, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
Trial summary
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Neurally Adjusted Ventilatory Assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 May 2023to 1 Jun 2024
- 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 minute to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born with congenital diaphragmatic hernia more than 34-weeks gestation
Who cannot join
- Receiving Nitric Oxide
- Requiring an FIO2 more than 80% to maintain SpO2: 85-95%.
- Severe chromosomal abnormality
- Severe cardiac anomalies requiring corrective surgery
- Renal anomalies
- Skeletal deformities suspected to impede thoracic or lung development
Show all 9Show fewer
- Severe central nervous system anomalies suspected to impede diaphragmatic signalling
- Use of neuromuscular blocking agents
- Contraindication to nasogastric tube insertion
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Kings College Hospital
London
St. George's University Hospital
London
About this study
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Our dual-centre randomised cross-over trial aims to investigate the efficacy of NIV-NAVA compared to ACV for supporting neonates with CDH.
Read the detailed description
Background:
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Evidence suggests that NAVA may reduce physiological parameters associated with lung pressure and hence reduce the risk of iatrogenic lung injury.
Aims:
Our aim is to compare the oxygenation index (OI) of neonates with CDH, ventilated with ACV and NIV-NAVA. The OI is calculated as the fractured of inspired oxygen x mean airway pressure x partial pressure of oxygen/100. The oxygenation index is used as a marker of hypoxic respiratory failure in infants with CDH and forms the basis of the criteria to administer nitric oxide.
Methods:
Our investigation is a dual-centre randomised cross-over trial. Infants will be identified and parents counselled in the first few days following delivery. Neonates that meet inclusion criteria will be randomised to receive either NIV-NAVA or ACV first, followed by the other method of ventilation. Infants will be stabilised on ACV one-hour prior to entering the trial. On entry into the trial, they will receive 4-hours of each ventilatory method with a 20-minute stabilisation break in between.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Neurally Adjusted Ventilatory Assist, Assist Control Ventilation
- Medical subject headings
- Hernias, Diaphragmatic, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurally Adjusted Ventilatory AssistDevice
Also called Assist Control Ventilation
NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen, to which proportion is set by the clinician as the NAVA level.
Assist Control VentilationDevice
ACV delivers fixed oxygen pressure set by the clinician at the start of each inspiratory breath.
| Study group | Role | What they receive |
|---|---|---|
| Neurally Adjusted Ventilatory Assist | Experimental | Infants will first be ventilated with NAVA for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with assist control ventilation (ACV). Receives: Device: Neurally Adjusted Ventilatory Assist; Device: Assist Control Ventilation |
| Assist Control Ventilation (ACV) | Experimental | Infants will first be ventilated with ACV for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with non-invasive neurally adjusted ventilatory assist. Receives: Device: Neurally Adjusted Ventilatory Assist; Device: Assist Control Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation Index (OI)
Oxygenation Index is calculated as MAP x FIO2 x PaO2/100. MAP is the mean airway pressure. FIO2 represents the concentration of inspired oxygen and PAO2 is the partial pressure of oxygen. The OI is a reliable indicator of lung function, previous research has shown its use in the prognostication of neonates with CDH.
Measured: Infants will receive each mode of ventilation for four hours. OI will be recorded every 5-minutes for the final 30-minutes of each ventilation period. The OI will be averaged over the 30-minute time frame. This average OI will then be compared.
Secondary outcomes (1)
Respiratory Severity Score (RSS)
The respiratory severity score is calculated as RSS = FIO2 x MAP. Where FIO2 represents the fraction of inspired oxygen and MAP is the mean airway pressure. In one multivariate analysis of 59 infants with CDH, RSS was an effective prognostic marker.
Measured: RSS will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start26 May 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
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 Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Model description
- Dual Centre Randomised Cross-Over Trial. Infants that meet inclusion criteria will be randomised to be ventilated with either NIV-NAVA or ACV for four hours, followed by the second mode of ventilation. There will be a 20-minute stabilisation period between ventilatory methods.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- St George's, University of London
- Responsible party
- Principal investigator, Anne Greenough, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839340
- Sponsor's protocol ID
- 319769
- Acronym
- NAN-C
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for individual participant data will be reviewed by the principal investigator. On request, data will be made available to other researchers 6-months following trial cessation. Parents will be consented to share their child's data for research purposes. All data will be anonymised on entry into the trial so no individual data point will be recognisable.
Publications
Poole G, Harris C, Shetty S, Dassios T, Jenkinson A, Greenough A. Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study. Trials. 2024 Jan 20;25(1):72. doi: 10.1186/s13063-023-07874-0.
PubMed 38245741
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias
- ClinicalTrials.gov ID
- NCT05839340
- Acronym / sponsor ID
- NAN-C / 319769
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- St George's, University of London
- Study start
- 26 May 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 3 May 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.
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Our dual-centre randomised cross-over trial aims to investigate the efficacy of NIV-NAVA compared to ACV for supporting neonates with CDH.
Detailed description
Background:
Congenital Diaphragmatic Hernias (CDH) are typically repaired surgically in the first few days of a neonate's life. Following surgical repair, infants usually require ventilatory support to ensure adequate oxygenation. Traditionally assist control ventilation (ACV) has been used to support neonates with CDH. Due to delivering a fixed pressure of oxygen, ACV has been associated with barotrauma and long-term lung damage. A more recent approach to ventilation is non-invasive neurally adjusted ventilatory assist (NIV-NAVA). NIV-NAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen. Evidence suggests that NAVA may reduce physiological parameters associated with lung pressure and hence reduce the risk of iatrogenic lung injury.
Aims:
Our aim is to compare the oxygenation index (OI) of neonates with CDH, ventilated with ACV and NIV-NAVA. The OI is calculated as the fractured of inspired oxygen x mean airway pressure x partial pressure of oxygen/100. The oxygenation index is used as a marker of hypoxic respiratory failure in infants with CDH and forms the basis of the criteria to administer nitric oxide.
Methods:
Our investigation is a dual-centre randomised cross-over trial. Infants will be identified and parents counselled in the first few days following delivery. Neonates that meet inclusion criteria will be randomised to receive either NIV-NAVA or ACV first, followed by the other method of ventilation. Infants will be stabilised on ACV one-hour prior to entering the trial. On entry into the trial, they will receive 4-hours of each ventilatory method with a 20-minute stabilisation break in between.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dual Centre Randomised Cross-Over Trial. Infants that meet inclusion criteria will be randomised to be ventilated with either NIV-NAVA or ACV for four hours, followed by the second mode of ventilation. There will be a 20-minute stabilisation period between ventilatory methods.
| Arm | Type | Receives |
|---|---|---|
| Neurally Adjusted Ventilatory Assist | Experimental | Device: Neurally Adjusted Ventilatory Assist, Device: Assist Control VentilationInfants will first be ventilated with NAVA for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with assist control ventilation (ACV). |
| Assist Control Ventilation (ACV) | Experimental | Device: Neurally Adjusted Ventilatory Assist, Device: Assist Control VentilationInfants will first be ventilated with ACV for four hours. Following this, they will undergo a 20-minute stabilisation period prior to ventilating with non-invasive neurally adjusted ventilatory assist. |
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants born with congenital diaphragmatic hernia more than 34-weeks gestation
Key exclusion criteria (9 listed)
- Receiving Nitric Oxide
- Requiring an FIO2 more than 80% to maintain SpO2: 85-95%.
- Severe chromosomal abnormality
- Severe cardiac anomalies requiring corrective surgery
- Renal anomalies
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 |
|---|---|---|
| Neurally Adjusted Ventilatory AssistAlso: Assist Control VentilationNAVA uses electrical signals of the diaphragm to deliver a proportional pressure of oxygen, to which proportion is set by the clinician as the NAVA level. | Device | Assist Control Ventilation (ACV), Neurally Adjusted Ventilatory Assist |
| Assist Control VentilationACV delivers fixed oxygen pressure set by the clinician at the start of each inspiratory breath. | Device | Assist Control Ventilation (ACV), Neurally Adjusted Ventilatory Assist |
Primary outcome
Oxygenation Index (OI)
Time frame: Infants will receive each mode of ventilation for four hours. OI will be recorded every 5-minutes for the final 30-minutes of each ventilation period. The OI will be averaged over the 30-minute time frame. This average OI will then be compared.
Oxygenation Index is calculated as MAP x FIO2 x PaO2/100. MAP is the mean airway pressure. FIO2 represents the concentration of inspired oxygen and PAO2 is the partial pressure of oxygen. The OI is a reliable indicator of lung function, previous research has shown its use in the prognostication of neonates with CDH.
1 secondary outcome
Respiratory Severity Score (RSS)
Time frame: RSS will be recorded every 5-minutes for the final 30-minutes that the infant is on each ventilation mode. This will be compared to their baseline 30-minutes pre-randomisation and between ventilation modes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 38245741Poole G, Harris C, Shetty S, Dassios T, Jenkinson A, Greenough A. Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study. Trials. 2024 Jan 20;25(1):72. doi: 10.1186/s13063-023-07874-0.
- Individual participant dataSharing planned: Yes. Requests for individual participant data will be reviewed by the principal investigator. On request, data will be made available to other researchers 6-months following trial cessation. Parents will be consented to share their child's data for research purposes. All data will be anonymised on entry into the trial so no individual data point will be recognisable.
Related trials for Congenital Diaphragmatic Hernia
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Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurally Adjusted Ventilatory Assist in people with Congenital Diaphragmatic Hernia, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
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?
Oxygenation Index (OI) (time frame: Infants will receive each mode of ventilation for four hours. OI will be recorded every 5-minutes for the final 30-minutes of each ventilation period. The OI will be averaged over the 30-minute time frame. This average OI will then be compared.). 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 NCT05839340, 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 1 Jun 2023.