Congenital Diaphragmatic HerniaCDH-ONVNCT02849054
CDH - Optimisation of Neonatal Ventilation
A study testing Measurement of PTPdi, TTV at 4ml/kg and TTV at 5ml/kg in people with Congenital Diaphragmatic Hernia, run by King's College London at 1 site in United Kingdom.
Trial summary
To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Measurement of PTPdi, TTV at 4ml/kg and TTV at 5ml/kg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to Dec 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at >34/40
Who cannot join
- neuromuscular blockade contraindications to NG/OG tube insertion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE59RS
Katie Hunt, MA, MBBS, 00442032999000 ext. 38492, katie.a.hunt@kcl.ac.uk
About this study
Official title: Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee
To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.
- Conditions
- Congenital Diaphragmatic Hernia
- Being tested
- Measurement of PTPdi, TTV at 4ml/kg, TTV at 5ml/kg, TTV at 6ml/kg
- 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.
Measurement of PTPdiDevice
Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
TTV at 4ml/kgDevice
Provision of targetted tidal volume of 4ml/kg
TTV at 5ml/kgDevice
Provision of targetted tidal volume of 5ml/kg
TTV at 6ml/kgDevice
Provision of targetted tidal volume of 6ml/kg
| Study group | Role | What they receive |
|---|---|---|
| 4, 5, 6ml/kg targetted tidal volume | Experimental | Randomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi Receives: Device: Measurement of PTPdi; Device: TTV at 4ml/kg; Device: TTV at 5ml/kg; Device: TTV at 6ml/kg |
| 4, 6, 5ml/kg targetted tidal volume | Experimental | Randomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi Receives: Device: Measurement of PTPdi; Device: TTV at 4ml/kg; Device: TTV at 5ml/kg; Device: TTV at 6ml/kg |
| 5, 4, 6ml/kg targetted tidal volume | Experimental | Randomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi Receives: Device: Measurement of PTPdi; Device: TTV at 4ml/kg; Device: TTV at 5ml/kg; Device: TTV at 6ml/kg |
| 5, 6, 4ml/kg targetted tidal volume | Experimental | Randomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi Receives: Device: Measurement of PTPdi; Device: TTV at 4ml/kg; Device: TTV at 5ml/kg; Device: TTV at 6ml/kg |
| 6, 5, 4ml/kg targetted tidal volume | Experimental | Randomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi Receives: Device: Measurement of PTPdi; Device: TTV at 4ml/kg; Device: TTV at 5ml/kg; Device: TTV at 6ml/kg |
| 6, 4, 5ml/kg targetted tidal volume | Experimental | Randomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi Receives: Device: Measurement of PTPdi; Device: TTV at 4ml/kg; Device: TTV at 5ml/kg; Device: TTV at 6ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume
PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Anne Greenough, MD, MBBS, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849054
- Sponsor's protocol ID
- KCH16-080
- Acronym
- CDH-ONV
- Status last verified
- Aug 2018
- First submitted
- 18 Jul 2016
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation of Neonatal Ventilation: Congenital Diaphragmatic Hernia - Determining the Appropriate Level of Volume Guarantee
- ClinicalTrials.gov ID
- NCT02849054
- Acronym / sponsor ID
- CDH-ONV / KCH16-080
- Conditions
- Congenital Diaphragmatic Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- Jun 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 29 Jul 2016 (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.
To determine the appropriate volume (size) of ventilator breath during volume-targetted ventilation for infants born with congenital diaphragmatic hernia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 4, 5, 6ml/kg targetted tidal volume | Experimental | Device: Measurement of PTPdi, Device: TTV at 4ml/kg, Device: TTV at 5ml/kg, Device: TTV at 6ml/kgRandomised to receive TTV at 4ml/kg, 5ml/kg, 6ml/kg. Measurement of PTPdi |
| 4, 6, 5ml/kg targetted tidal volume | Experimental | Device: Measurement of PTPdi, Device: TTV at 4ml/kg, Device: TTV at 5ml/kg, Device: TTV at 6ml/kgRandomised to receive TTV at 4ml/kg, 6ml/kg, 5ml/kg. Measurement of PTPdi |
| 5, 4, 6ml/kg targetted tidal volume | Experimental | Device: Measurement of PTPdi, Device: TTV at 4ml/kg, Device: TTV at 5ml/kg, Device: TTV at 6ml/kgRandomised to receive TTV at 5ml/kg, 4ml/kg, 6ml/kg. Measurement of PTPdi |
| 5, 6, 4ml/kg targetted tidal volume | Experimental | Device: Measurement of PTPdi, Device: TTV at 4ml/kg, Device: TTV at 5ml/kg, Device: TTV at 6ml/kgRandomised to receive TTV at 5ml/kg, 6ml/kg,4ml/kg. Measurement of PTPdi |
| 6, 5, 4ml/kg targetted tidal volume | Experimental | Device: Measurement of PTPdi, Device: TTV at 4ml/kg, Device: TTV at 5ml/kg, Device: TTV at 6ml/kgRandomised to receive TTV at 6ml/kg, 5ml/kg, 4ml/kg. Measurement of PTPdi |
| 6, 4, 5ml/kg targetted tidal volume | Experimental | Device: Measurement of PTPdi, Device: TTV at 4ml/kg, Device: TTV at 5ml/kg, Device: TTV at 6ml/kgRandomised to receive TTV at 6ml/kg, 4ml/kg, 5ml/kg. Measurement of PTPdi |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Congenital diaphragmatic hernia - post-operative Mechanically ventilated Born at >34/40
Key exclusion criteria (1 listed)
- neuromuscular blockade contraindications to NG/OG tube insertion
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 PTPdiInsertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi | Device | 4, 5, 6ml/kg targetted tidal volume, 4, 6, 5ml/kg targetted tidal volume, 5, 4, 6ml/kg targetted tidal volume, 5, 6, 4ml/kg targetted tidal volume, 6, 4, 5ml/kg targetted tidal volume, 6, 5, 4ml/kg targetted tidal volume |
| TTV at 4ml/kgProvision of targetted tidal volume of 4ml/kg | Device | 4, 5, 6ml/kg targetted tidal volume, 4, 6, 5ml/kg targetted tidal volume, 5, 4, 6ml/kg targetted tidal volume, 5, 6, 4ml/kg targetted tidal volume, 6, 4, 5ml/kg targetted tidal volume, 6, 5, 4ml/kg targetted tidal volume |
| TTV at 5ml/kgProvision of targetted tidal volume of 5ml/kg | Device | 4, 5, 6ml/kg targetted tidal volume, 4, 6, 5ml/kg targetted tidal volume, 5, 4, 6ml/kg targetted tidal volume, 5, 6, 4ml/kg targetted tidal volume, 6, 4, 5ml/kg targetted tidal volume, 6, 5, 4ml/kg targetted tidal volume |
| TTV at 6ml/kgProvision of targetted tidal volume of 6ml/kg | Device | 4, 5, 6ml/kg targetted tidal volume, 4, 6, 5ml/kg targetted tidal volume, 5, 4, 6ml/kg targetted tidal volume, 5, 6, 4ml/kg targetted tidal volume, 6, 4, 5ml/kg targetted tidal volume, 6, 5, 4ml/kg targetted tidal volume |
Primary outcome
Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume
Time frame: 3 hours
PTPdi will be measured at each level of tidal volume. The outcome measure is the change in PTPdi.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Anne Greenough, MD, MBBS principal investigator
King's College London
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 PTPdi, TTV at 4ml/kg and TTV at 5ml/kg in people with Congenital Diaphragmatic Hernia, run by King's College London at 1 site 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 1 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 29 Aug 2018. 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 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?
Contact Katie Hunt, MA, MBBS (00442032999000 ext. 38492, katie.a.hunt@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pressure Time Product of the diaphragm (PTPdi) at different levels of targetted tidal volume (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2018.