Apnea of PrematurityNAVAPNEANCT07923604
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
A study testing nCPAP-NAVA-backup mode and nCPAP mode in people with Apnea of Prematurity, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- nCPAP-NAVA-backup mode and nCPAP mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Born at ≤28 weeks gestational age
- Currently receiving nCPAP mode as part of routine care
- Receiving caffeine citrate at a maintenance dose of 10 mg/kg/day
- An average of ≥1 severe apnea per hour over a 6-hour period (apnea associated with SpO₂<85% during ≥ 5 seconds and/or HR <100 bpm during ≥ 5 seconds) or an average of >2 severe apnea per hour over a 2-hour period
- Written informed consent obtained from the legal representatives before inclusion.
Who cannot join
- Major congenital anomalies (e.g., congenital diaphragmatic hernia, significant cardiac malformations)
- Known genetic syndrome affecting respiratory function
- Immediate indication for endotracheal intubation or noninvasive ventilation (NIV)
- Parental refusal or withdrawal of consent
- Previous inclusion in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University hospital of Geneva
Geneva
Dimitra Papasavva, dimitra.papasavva@hug.ch
About this study
Official title: Effect of nCPAP-NAVA-backup Mode Versus Standard nCPAP Mode on the Reduction of Severe Apnea in Preterm Infants ≤ 28 Weeks - a Crossover Trial
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.
Read more
Randomized sequences to avoid order effects:
- Sequence A: nCPAP mode → nCPAP-NAVA-backup mode
- Sequence B: nCPAP-NAVA-backup mode →nCPAP mode
- Conditions
- Apnea of Prematurity
- Being tested
- nCPAP-NAVA-backup mode, nCPAP mode
- Keywords
- Apnea, nCPAP, nCPAP-NAVA-Backup, Prematurity, Desaturation, Bradycardia, NAVAPNEA, NAVA, Back-up
- Medical subject headings
- Apnea, Premature Birth, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCPAP-NAVA-backup modeDevice
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.
nCPAP modeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: nCPAP then nCPAP-NAVA-Backup | Experimental | 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. Receives: Device: nCPAP-NAVA-backup mode; Device: nCPAP mode |
| Sequence B: nCPAP-NAVA-backup then nCPAP | Experimental | 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. Receives: Device: nCPAP-NAVA-backup mode; Device: nCPAP mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Per 9-hour observation period
Secondary outcomes (10)
Number of isolated oxygen desaturation episodes
SpO₂ < 85% for ≥ 5 seconds, not associated with a severe apnea episode
Measured: Per 9-hour observation period
Number of isolated bradycardia episodes
HR < 100 bpm for ≥ 5 seconds, not associated with a severe apnea episode
Measured: per 9-hour observation period
Number of hyperoxia episodes (SpO₂ > 94% for ≥ 5 seconds)
Measured: per 9-hour observation period
Percentage of time spent with SpO₂ < 85%
Measured: per 9-hour observation period
Percentage of time spent with SpO₂ > 94%
Measured: per 9-hour observation period
Percentage of time spent with HR < 100 bpm
Measured: per 9-hour observation period
Number of apnea episodes requiring nurse intervention
tactile stimulation and/or increase in FiO₂
Measured: 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
Measured: 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
Measured: 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.
Measured: per 9-hour observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Each infant will receive both interventions (nCPAP mode and nCPAP-NAVA-backup mode) in a randomized order, serving as their own control (crossover). 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: * Sequence A: nCPAP mode → nCPAP-NAVA-backup mode * Sequence B: nCPAP-NAVA-backup mode →nCPAP mode
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitra Papasavva, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923604
- Sponsor's protocol ID
- 2026-00663
- Other IDs
- HumRes
- Acronym
- NAVAPNEA
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of nCPAP-NAVA-backup Mode Versus Standard nCPAP Mode on the Reduction of Severe Apnea in Preterm Infants ≤ 28 Weeks - a Crossover Trial
- ClinicalTrials.gov ID
- NCT07923604
- Acronym / sponsor ID
- NAVAPNEA / 2026-00663
- Conditions
- Apnea of Prematurity
- Keywords
- Apnea, nCPAP, nCPAP-NAVA-Backup, Prematurity, Desaturation, Bradycardia, NAVAPNEA, NAVA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Nov 2026 (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.
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:
- Sequence A: nCPAP mode → nCPAP-NAVA-backup mode
- Sequence B: nCPAP-NAVA-backup mode →nCPAP mode
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each infant will receive both interventions (nCPAP mode and nCPAP-NAVA-backup mode) in a randomized order, serving as their own control (crossover). 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: * Sequence A: nCPAP mode → nCPAP-NAVA-backup mode * Sequence B: nCPAP-NAVA-backup mode →nCPAP mode
| Arm | Type | Receives |
|---|---|---|
| Sequence A: nCPAP then nCPAP-NAVA-Backup | Experimental | Device: nCPAP-NAVA-backup mode, Device: nCPAP modePreterm 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. |
| Sequence B: nCPAP-NAVA-backup then nCPAP | Experimental | Device: nCPAP-NAVA-backup mode, Device: nCPAP modePreterm 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Born at ≤28 weeks gestational age
- Currently receiving nCPAP mode as part of routine care
- Receiving caffeine citrate at a maintenance dose of 10 mg/kg/day
- An average of ≥1 severe apnea per hour over a 6-hour period (apnea associated with SpO₂<85% during ≥ 5 seconds and/or HR <100 bpm during ≥ 5 seconds) or an average of >2 severe apnea per hour over a 2-hour period
- Written informed consent obtained from the legal representatives before inclusion.
Key exclusion criteria (5 listed)
- Major congenital anomalies (e.g., congenital diaphragmatic hernia, significant cardiac malformations)
- Known genetic syndrome affecting respiratory function
- Immediate indication for endotracheal intubation or noninvasive ventilation (NIV)
- Parental refusal or withdrawal of consent
- Previous inclusion in the study
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 |
|---|---|---|
| nCPAP-NAVA-backup modeStandard 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. | Device | Sequence A: nCPAP then nCPAP-NAVA-Backup, Sequence B: nCPAP-NAVA-backup then nCPAP |
| nCPAP modeStandard 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. | Device | Sequence A: nCPAP then nCPAP-NAVA-Backup, Sequence B: nCPAP-NAVA-backup then nCPAP |
Primary outcome
Number of severe apnea episodes per 9-hour observation period
Time frame: 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
10 secondary outcomes
Number of isolated oxygen desaturation episodes
Time frame: Per 9-hour observation period
Number of isolated bradycardia episodes
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
Time frame: per 9-hour observation period
Need for escalation of respiratory support during the observation period
Time frame: per 9-hour observation period
Infant comfort assessed using the EDIN score (Échelle Douleur Inconfort Nouveau-Né)
Time frame: per 9-hour observation period
Gastrointestinal tolerance
Time frame: per 9-hour observation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
Related trials for Apnea of Prematurity
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates
Neonatal Resuscitation, Apnea Neonatal
RecruitingObservational study
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age
Premature Birth, Asthma in Children
Not yet recruitingObservational study
Automated Apnoea Detection in Preterms on Non-invasive Ventilation
Apnoea, Prematurity
Not yet recruiting
MICropsampling for CAffeine in PREMature Newborns
Apnea of Prematurity
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCPAP-NAVA-backup mode and nCPAP mode in people with Apnea of Prematurity, run by University Hospital, Geneva at 1 site in Switzerland.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of severe apnea episodes per 9-hour observation period (time frame: Per 9-hour observation period). 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 6 Nov 2026.