Infant, Newborn, DiseaseEMGNCT02878993
Predicting Infant Extubation Using Diaphragm Surface Electromyography
An observational study of Infant, Newborn, Disease, run by King's College London at 1 site in United Kingdom.
Trial summary
This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.) Read more about this study
- Who is it for?
- Ages 0 days to 12 months
- Conditions the study is for
- Infant, Newborn, Disease
- What is being tested?
- Recording of diaphragm EMG
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Aug 2018
- Phase
- Observational
- 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 0 days to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants mechanically ventilated on NICU without major congenital abnormalities
Who may be able to join
- intubated and mechanically ventilated on NICU
Who cannot join
- major congenital abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)
Read the detailed description
This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)
- Conditions
- Infant, Newborn, Disease
- Being tested
- Recording of diaphragm EMG
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of diaphragm EMGDevice
Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography
| Study group | Role | What they receive |
|---|---|---|
| Intubated infants | Recording of diaphragm EMG Receives: Device: Recording of diaphragm EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of diaphragm EMG
Magnitude of diaphragm EMG
Measured: One hour
Ratio of diaphragm EMG to tidal volume
Ratio of diaphragm EMG to tidal volume
Measured: One hour
Secondary outcomes (1)
Extubation success
Extubation success is define as remaining free of invasive mechanical ventilation. Whether the above measures of diaphragm EMG can predict such success will be investigated
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMay 2018
- Study completionAug 2018
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 Infant, Newborn, DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
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, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878993
- Sponsor's protocol ID
- KCH16-100
- Other IDs
- 16/LO/1281, 205807
- Acronym
- EMG
- Status last verified
- Mar 2018
- First submitted
- 22 Aug 2016
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hunt KA, Hunt I, Ali K, Dassios T, Greenough A. Prediction of extubation success using the diaphragmatic electromyograph results in ventilated neonates. J Perinat Med. 2020 Jul 28;48(6):609-614. doi: 10.1515/jpm-2020-0129.
PubMed 32598319
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Infant Extubation Using Diaphragm Surface Electromyography
- ClinicalTrials.gov ID
- NCT02878993
- Acronym / sponsor ID
- EMG / KCH16-100
- Conditions
- Infant, Newborn, Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- Aug 2016
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 25 Aug 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.
This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)
Detailed description
This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubated infants | – | Device: Recording of diaphragm EMGRecording of diaphragm EMG |
Who may qualify
- Ages
- 0 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants mechanically ventilated on NICU without major congenital abnormalities
Key inclusion criteria (1 listed)
- intubated and mechanically ventilated on NICU
Key exclusion criteria (1 listed)
- major congenital abnormalities
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 |
|---|---|---|
| Recording of diaphragm EMGRecording of diaphragm EMG prior to extubation using surface diaphragm electromyography | Device | Intubated infants |
Primary outcome
Magnitude of diaphragm EMG
Time frame: One hour
Magnitude of diaphragm EMG
Ratio of diaphragm EMG to tidal volume
Time frame: One hour
Ratio of diaphragm EMG to tidal volume
1 secondary outcome
Extubation success
Time frame: 48 hours
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 2 Nov 2020.
- Background: PubMed 32598319Hunt KA, Hunt I, Ali K, Dassios T, Greenough A. Prediction of extubation success using the diaphragmatic electromyograph results in ventilated neonates. J Perinat Med. 2020 Jul 28;48(6):609-614. doi: 10.1515/jpm-2020-0129.
- Individual participant dataSharing planned: No
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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 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?
An observational study of Infant, Newborn, Disease, 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: finished, as of the sponsor's last update on 2 Nov 2020. 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?
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?
Magnitude of diaphragm EMG (time frame: One hour). The study lists 2 primary outcomes in all. 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 NCT02878993, 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 2 Nov 2020.