nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks (NAVAPNEA)
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.
Randomized sequences to avoid order effects:
- Sequence A: nCPAP mode → nCPAP-NAVA-backup mode
- Sequence B: nCPAP-NAVA-backup mode →nCPAP mode
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Geneva, 스위스
- University hospital of Geneva
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연락하다:
- Dimitra Papasavva
- 이메일: dimitra.papasavva@hug.ch
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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. |
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. |
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실험적: 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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of severe apnea episodes per 9-hour observation period
기간: Per 9-hour observation period
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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 |
Per 9-hour observation period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of isolated oxygen desaturation episodes
기간: Per 9-hour observation period
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SpO₂ < 85% for ≥ 5 seconds, not associated with a severe apnea episode |
Per 9-hour observation period
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Number of isolated bradycardia episodes
기간: per 9-hour observation period
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HR < 100 bpm for ≥ 5 seconds, not associated with a severe apnea episode |
per 9-hour observation period
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Number of hyperoxia episodes (SpO₂ > 94% for ≥ 5 seconds)
기간: per 9-hour observation period
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per 9-hour observation period
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Percentage of time spent with SpO₂ < 85%
기간: per 9-hour observation period
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per 9-hour observation period
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Percentage of time spent with SpO₂ > 94%
기간: per 9-hour observation period
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per 9-hour observation period
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Percentage of time spent with HR < 100 bpm
기간: per 9-hour observation period
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per 9-hour observation period
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Number of apnea episodes requiring nurse intervention
기간: per 9-hour observation period
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tactile stimulation and/or increase in FiO₂ |
per 9-hour observation period
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Need for escalation of respiratory support during the observation period
기간: per 9-hour observation period
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Defined as requirement for transition to non-invasive ventilation mode or endotracheal intubation |
per 9-hour observation period
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Infant comfort assessed using the EDIN score (Échelle Douleur Inconfort Nouveau-Né)
기간: per 9-hour observation period
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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 |
per 9-hour observation period
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Gastrointestinal tolerance
기간: per 9-hour observation period
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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. |
per 9-hour observation period
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026-00663
- HumRes (기타 식별자: Human research in Switzerland)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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