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
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究場所
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-
-
Geneva、スイス
- University hospital of Geneva
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コンタクト：
- Dimitra Papasavva
- メール：dimitra.papasavva@hug.ch
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-
参加基準
適格基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of severe apnea episodes per 9-hour observation period
時間枠：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 |
Per 9-hour observation period
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of isolated oxygen desaturation episodes
時間枠：Per 9-hour observation period
|
SpO₂ < 85% for ≥ 5 seconds, not associated with a severe apnea episode |
Per 9-hour observation period
|
|
Number of isolated bradycardia episodes
時間枠：per 9-hour observation period
|
HR < 100 bpm for ≥ 5 seconds, not associated with a severe apnea episode |
per 9-hour observation period
|
|
Number of hyperoxia episodes (SpO₂ > 94% for ≥ 5 seconds)
時間枠：per 9-hour observation period
|
per 9-hour observation period
|
|
|
Percentage of time spent with SpO₂ < 85%
時間枠：per 9-hour observation period
|
per 9-hour observation period
|
|
|
Percentage of time spent with SpO₂ > 94%
時間枠：per 9-hour observation period
|
per 9-hour observation period
|
|
|
Percentage of time spent with HR < 100 bpm
時間枠：per 9-hour observation period
|
per 9-hour observation period
|
|
|
Number of apnea episodes requiring nurse intervention
時間枠：per 9-hour observation period
|
tactile stimulation and/or increase in FiO₂ |
per 9-hour observation period
|
|
Need for escalation of respiratory support during the observation period
時間枠：per 9-hour observation period
|
Defined as requirement for transition to non-invasive ventilation mode or endotracheal intubation |
per 9-hour observation period
|
|
Infant comfort assessed using the EDIN score (Échelle Douleur Inconfort Nouveau-Né)
時間枠：per 9-hour observation period
|
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
|
|
Gastrointestinal tolerance
時間枠：per 9-hour observation period
|
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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 2026-00663
- HumRes (その他の識別子：Human research in Switzerland)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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