Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP
Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.
調査の概要
状態
詳細な説明
Respiratory distress and the need for respiratory support continues to be a common problem for preterm infants. Presence of the breathing tube and duration of respirator provided breaths have been shown to be associated with increased risk for secondary lung injury and subsequent development of chronic lung disease of prematurity. Early application of noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an effective, non-invasive, mode of respiratory support in preterm infants and to be associated with a lower incidence of chronic lung disease. A recently published large randomized multicenter study concluded that, among infants born at 28 weeks and longer gestation, heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with breathing problems.
This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. In this study, infants will remain on the assigned treatment of either NCPAP or HHHFNC until they require more support as provided by a respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided by their attending physician. The infant's respiratory support will be managed according to his/her attending doctor as per accepted standards of care. A pulmonary function test will be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC support, followed-up by once weekly lung function measurements post respiratory support while infants are breathing only room air until discharge.
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
- Pennsylvania Hospital
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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:
- Birth weight greater than or equal to 1000 grams.
- Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
Candidate for non-invasive respiratory support as a result of:
- An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
- An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
- Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.
Exclusion Criteria:
- Birth weight less than 1000 grams.
- Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
- Active air leak syndrome.
- Subjects will not be eligible if they are not considered viable.
- Infants with abnormalities of the upper and lower airways
- Infants with significant abdominal or respiratory malformations .
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:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の:HHHFNC
Treatment of respiratory distress by Heated Humidified High Flow Nasal Cannula (HHHFNC). Escalation of the ventilatory support per protocol and the attending physician. |
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on HHHFNC and weekly when weaned off until 40 weeks post conceptional age or discharge.
Recording of the level and the type of respiratory support and all cross over respiratory support devices.
Recording of all growth parameters, neonatal morbidities and therapies.
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他の:NCPAP
Treatment of respiratory distress by nasal continuous positive airway pressure (NCPAP). Escalation of the ventilatory support per protocol and the attending physician. |
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on NCPAP and weekly when weaned off until 40 weeks post conceptional age or discharge.
Recording of the level and the type of respiratory support and all cross over respiratory support devices.
Recording of all growth parameters, neonatal morbidities and therapies.
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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 |
|---|---|---|
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Pulmonary mechanics and chest wall asynchrony measures.
時間枠:2 years
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Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP.
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2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Duration of respiratory support or oxygen use up to the time of discharge from the NICU.
時間枠:2 years
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The total number of days while infants are on any type of respiratory support or oxygen use prior to discharge in preterm infants treated with HHHFNC compared to NCPAP during their hospital stay.
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2 years
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The incidence of potential adverse outcomes associated with HHHFNC or NCPAP.
時間枠:2 years
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The number and percentage of infants in each group with adverse effects such as facial and upper airways injury associated with the use of HHHFNC or NCPAP.
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2 years
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Time needed to establish full enteral feeds
時間枠:2 years
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The total number of days needed to establish full enteral feeds in preterm infants treated with HHHFNC as compared to preterm infants treated with NCPAP.
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2 years
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協力者と研究者
捜査官
- 主任研究者:Soraya Abbasi, MD、University of Pennsylvania
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 12-009882
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