An observational study in Apnoea and Prematurity, sponsored by King's College Hospital NHS Trust. Not yet recruiting. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by King's College Hospital NHS Trust · Observational
The aim of this study is to monitor the frequency of apnoeas (pauses in breathing) on various methods of non-invasive respiratory support that are detected by an automated machine-learning (ML) model based on diaphragmatic electromyography (dEMG), in infants born at less than 32 weeks of gestation.
Our hypothesis is that the ML algorithm will improve identification of apnoeic episodes and their classification to central or obstructive.
The study will measure outcomes including the number of apnoeic episodes during the monitoring period, their classification to central and obstructive apnoeas and the predictive ability of the machine-learning algorithm to correctly identify and classify these episodes compared to those documented in nursing charts. Correct classification of apnoeic episodes may help identify underlying causes that require specific intervention.
When the clinical team identifies an infant is eligible for enrolment to the study and following verbal assent of the attending neonatal consultant, a member of clinical staff will initially approach the parents/ legal guardians of eligible infants and if they agree, a researcher. The parents will be provided with an information sheet about the study. The researchers will answer questions and respond to any concerns in a face-to-face meeting. Written informed consent will be obtained.
Electrical activity of the diaphragm, airway pressure, flow and peripheral oxygen saturation levels will be recorded for a duration of eight hours. Transcutaneous diaphragm EMG (sEMG) will be monitored using three surface electrodes (3M Red Dot Foam monitoring electrode 2228, 3M, United Kingdom) that are placed on the infant's abdomen and sternum. The electrodes are connected to a small battery-operated measuring device (SERA, DEMCON; Makawi Medical Systems, the Netherlands) that amplifies and pre-processes the signals received from the electrodes. The pre-processed signals are sent via a Bluetooth connection to a receiving unit that performs higher level processing to derive the EMG signal and other measurements. These results are communicated via a wired connection to a bedside computer running SERA Graphical User Interface (GUI) software.
Airway pressure and flow signals will be measured by a flow sensor and pressure tube (Sensirion AG, Stäfa, Switzerland) that will be placed between the exit of the SLE6000/ SLE6000N ventilators (Inspiration Healthcare, Croydon, UK) and the tubing that is attached to the patient. This will ensure pressure and flow data are recorded simultaneously with the sEMG signal. These data will also be fed to the SERA measuring device.
An SpO2 cable (SLE uSpO2, Inspiration Healthcare, Croydon, UK) will be connected to the patient and the ventilator for continuous (second by second) recording of SpO2 levels. These data will be time synced using post processing.
Participants will also be connected to the standard bedside monitor (Phillips Intellivue MX750) for the whole duration of the study.
Surface EMG, pressure, flow and SpO2 data will be synchronised. Two researchers will identify all apnoeic episodes and classify them as central, obstructive or noise.
The ML algorithm will also be used to identify and classify apnoeic episodes that occurred during the study duration.
Comparisons will be made between the apnoeic episodes identified the researchers, the ML algorithm and the nursing staff electronic patient records. These records include classification of an episode as apnoea or desaturation or bradycardia, its duration and any actions taken.
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 78 observational studies indexed under Apnea.
Browse Apnea studies →King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants admitted and cared for at the Neonatal Intensive Care Unit at King's College Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Preterm infants \<32 weeks of gestation at birth and up to 36 weeks postmenstrual age, on non-invasive respiratory support including:
Exclusion Criteria:
Electrical activity of the diaphragm, airway pressure, flow and peripheral oxygen saturation levels will be recorded for a duration of eight hours. Transcutaneous diaphragm EMG (sEMG) will be monitored using three surface electrodes (3M Red Dot Foam monitoring electrode 2228, 3M, United Kingdom) that are placed on the infant's abdomen and sternum. The electrodes are connected to a small battery-operated measuring device (SERA, DEMCON; Makawi Medical Systems, the Netherlands) that amplifies and pre-processes the signals received from the electrodes. The pre-processed signals are sent via a Bluetooth connection to a receiving unit that performs higher level processing to derive the EMG signal and other measurements. These results are communicated via a wired connection to a bedside computer running SERA Graphical User Interface (GUI) software. Airway pressure and flow signals will be measured by a flow sensor and pressure tube (Sensirion AG, Stäfa, Switzerland) that will be placed betwe
Also known as: Airway pressure and flow measurements, Recording of peripheral oxygen saturation levels
Number of apnoeic episodes correctly identified by the automated machine learning model
Time frame: From enrollment to the end of monitoring at eight hours
The proportion of apnoeas correctly classified as central or obstructive by the automated machine learning model
Time frame: From enrollment to the end of monitoring at eight hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.
Of 35 observational studies under Apnea, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 38. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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