nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Not applicable

Age range

Not specified - 4 months

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

25 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

University Hospital, Geneva

Study start

2026-12 Estimated

Primary completion

2028-12 Estimated

Study completion

2028-12 Estimated

First posted

Nov 6, 2026 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.