Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
Nasal High-frequency Oscillatory Ventilation (NHFOV) vs Nasal Continuous Positive Airway Pressure(NCPAP) for Ventilated Newborn Infants With BPD: a Randomized Controlled Trial
調査の概要
状態
介入・治療
詳細な説明
Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.
We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Chen(陈) Long, MD, PhD
- 電話番号:+8613883559467
- メール:neuroclong@126.com
研究場所
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-
Chongqing
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Chongqing、Chongqing、中国、400014
- 募集
- Chen(陈)
-
コンタクト:
- Chen(陈) Long, MD,PhD
- 電話番号:+8613883559467
- メール:neuroclong@126.com
-
-
参加基準
適格基準
就学可能な年齢
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:
Eligibility requirements for neonates:
- The gestational age is less than 32 weeks
- The preterm neonates are diagnosed with BPD and need invasive ventilation
- Extubation and subsequent noninvasive ventilation is ready to be carried out
Exclusion Criteria:
one of the following conditions is needed:
- there were no intraventricular hemorrhage(IVH) grades 3 or 4
- major congenital anomalies
- parents' decision not to participate
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:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
|
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
|
|
アクティブコンパレータ:NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
|
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
re-intubation rate
時間枠:seven days after extubation
|
the newborn infants with ventilated BPD is reintubated after extubation
|
seven days after extubation
|
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death
時間枠:seven days after extubation
|
the newborn infants with BPD die
|
seven days after extubation
|
|
the level of carbon dioxide
時間枠:seven days after extubation
|
the level of carbon dioxide is measure after extubation between groups
|
seven days after extubation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
necrotizing entercolitis(NEC)
時間枠:seven days after extubation
|
the newborn infants with BPD is diagnosed with NEC
|
seven days after extubation
|
|
intraventricular hemorrhage(IVH)
時間枠:seven days after extubation
|
the newborn infants with BPD is diagnosed with NEC
|
seven days after extubation
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。