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NCT07923604
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Conditions: Apnea of Prematurity
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: University Hospital, Geneva
Location: University hospital of Geneva Geneva
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 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
Eligibility Criteria
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\
Source: ClinicalTrials.gov (NCT07923604). StuddyBuddy aggregates publicly available trial information.