Aún no reclutaNCT07923604Registro de ClinicalTrials.gov

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

Apnea of Prematurity

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LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: No especificado - 4 meses
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 25 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Sin enmascaramiento

Sequence A: nCPAP then nCPAP-NAVA-Backup

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

Sequence B: nCPAP-NAVA-backup then nCPAP

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

nCPAP-NAVA-backup mode DEVICE

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 mode DEVICE

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Number of severe apnea episodes per 9-hour observation period

Plazo: 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

Medidas secundarias

Number of isolated oxygen desaturation episodes

Plazo: Per 9-hour observation period

SpO₂ \< 85% for ≥ 5 seconds, not associated with a severe apnea episode

Number of isolated bradycardia episodes