An interventional study of nCPAP-NAVA-backup mode and nCPAP mode in Apnea of Prematurity, sponsored by University Hospital, Geneva. Not yet recruiting at 1 site in Switzerland. Open to participants aged Up to 4 Months. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University Hospital, Geneva · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to determine whether nasal continuous positive airway pressure (nCPAP) with neurally adjusted ventilatory assist (NAVA) backup ventilation (nCPAP-NAVA-backup mode) reduces the rate of severe apnea in extremely preterm infants ≤28 weeks' gestation compared with standard nasal continuous positive airway pressure (nCPAP mode). Severe apnea episodes is defined as breathing pause with oxygen levels ( SpO2) below 85% lasting at least 5 seconds and/or heart rate (HR) below 100 beats/minute lasting at least 5 seconds.
Each participant will receive both interventions in a randomized order, serving as their own control. The total duration of the intervention will be 24h. Each intervention period will last 12 hours. A washout period of 3 hours will be included between intervention periods to minimize potential carryover effects.
Randomized sequences to avoid order effects:
282 studies on the registry are indexed under Apnea; 54 are open to participants now.
This study's planned enrollment of 25 is below the median of 60 across 195 interventional studies indexed under Apnea.
Browse Apnea studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preterm infants randomized to receive 12 hours of standard nCPAP mode followed by 12 hours of nCPAP-NAVA-backup mode (total 24 hours) on a Servo-n ventilator. A 3-hour washout period at the start of each period is excluded from analysis.
Device: nCPAP-NAVA-backup mode · Device: nCPAP mode
Preterm infants randomized to receive 12 hours of nCPAP-NAVA-backup mode followed by 12 hours of standard nCPAP mode (total 24 hours) on a Servo-n ventilator. A 3-hour washout period at the start of each period is excluded from analysis.
Device: nCPAP-NAVA-backup mode · Device: nCPAP mode
Standard nasal CPAP delivered via a Servo-n ventilator, with continuous monitoring of the electrical activity of the diaphragm (Edi) through an Edi catheter that also serves as the feeding tube. When an apnea exceeds the preset apnea time, pressure-controlled backup ventilation is triggered automatically. Backup and PEEP settings follow unit standards, and PEEP is kept constant throughout the study. Duration: 12 hours.
Standard nasal CPAP delivered via nasal prongs or mask on the same Servo-n ventilator and circuit, with PEEP and FiO₂ managed according to standard clinical practice. Duration: 12 hours.
Number of severe apnea episodes per 9-hour observation period
Number of severe apnea episodes per 9-hour observation period, defined as an apnea associated with oxygen desaturation (SpO₂ \< 85%) lasting ≥ 5 seconds and/or bradycardia (Heart rate (HR) \< 100 bpm) lasting ≥ 5 seconds
Time frame: Per 9-hour observation period
Number of isolated oxygen desaturation episodes
SpO₂ \< 85% for ≥ 5 seconds, not associated with a severe apnea episode
Time frame: Per 9-hour observation period
Number of isolated bradycardia episodes
HR \< 100 bpm for ≥ 5 seconds, not associated with a severe apnea episode
Time frame: per 9-hour observation period
Number of hyperoxia episodes (SpO₂ > 94% for ≥ 5 seconds)
Time frame: per 9-hour observation period
Percentage of time spent with SpO₂ < 85%
Time frame: per 9-hour observation period
Percentage of time spent with SpO₂ > 94%
Time frame: per 9-hour observation period
Percentage of time spent with HR < 100 bpm
Time frame: per 9-hour observation period
Number of apnea episodes requiring nurse intervention
tactile stimulation and/or increase in FiO₂
Time frame: per 9-hour observation period
Need for escalation of respiratory support during the observation period
Defined as requirement for transition to non-invasive ventilation mode or endotracheal intubation
Time frame: per 9-hour observation period
Infant comfort assessed using the EDIN score (Échelle Douleur Inconfort Nouveau-Né)
EDIN will be recorded every 3 hours (0-15), yielding up to 3 measurements per 9-hour observation period. The mean EDIN score over each observation period will be used
Time frame: per 9-hour observation period
Gastrointestinal tolerance
Grade 1: good tolerance - enteral feeding maintained at prescribed volume with no significant gastric residuals ; Grade 2: moderate intolerance - enteral feeding volume reduced due to gastric residuals or clinical concern ;Grade 3: poor tolerance - enteral feeding discontinued with initiation of continuous gastric suctioning. The worst grade recorded during each 9-hour observation period will be used as the summary measure for analysis.
Time frame: per 9-hour observation period
PDFs hosted by the registry, ClinicalTrials.gov.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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