徐脈を伴う新生児の無呼吸を予測するための応用 (APNeA)
徐脈を伴う新生児の無呼吸を予測するための適用（無呼吸研究）
This purpose of this study is to reduce or stop apneas and bradycardias in pre-term infants, before they occur using gentle stimulation.
調査の概要
詳細な説明
This will be a randomized cross-over trial that will use additional ECG leads connected to a novel device and laptop to determine the accuracy and efficacy of an algorithm to predict, detect, and interrupt episodes of bradycardia for two 4-hour periods. There will be a 4-hour period without vibro-tactile stimulation and a 4-hour period with vibro-tactile stimulation when episodes are predicted or detected.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rachel L. Benz, Clinical Research Nurse Manager, MSN
- 電話番号：205-934-2184
- メール：rlbenz@uabmc.edu
研究連絡先のバックアップ
- 名前：Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- 電話番号：205-934-0095
- メール：karmstead@uabmc.edu
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35209
- 募集
- University of Alabama at Birmingham
-
コンタクト：
- Kimberly M. Armstead Clinical Research Coordinator III, B.S.
- 電話番号：205-934-0095
- メール：karmstead@uabmc.edu
-
コンタクト：
- Rachel L Benz Clinical Research Nurse Manager, MSN
- 電話番号：205-934-2184
- メール：rlbenz@uabmc.edu
-
主任研究者：
- Colm P. Travers, M.D.
-
-
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:
- Documented episodes of apnea with bradycardia over the previous 24 hours.
- Off ventilatory support/NCPAP for > 48 hours prior to study entry
- Gestational age < 32 0/7 weeks' gestation at birth
- Parents/legal guardians have provided consent for enrollment
Exclusion Criteria:
- a major malformation or a neuromuscular condition that affects respiration or causes apnea, or terminal illness or decision to withhold or limit support.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Virbrotactile stimulation
Four hours of vibrotactile stimulation via a closed loop device if an apnea or bradycardia episode is predicted or detected. |
Vibro-Tactile stimulation when bradycardia is predicted or predicted. |
|
偽コンパレータ：Control
Four hours of no vibrotactile stimulation via the closed loop device if an apnea or bradycardia episode is predicted or detected. |
Sham closed-loop vibrotactile stimulator |
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 |
|---|---|---|
|
Bradycardia <100 beats per minute ≥ 10 seconds
時間枠：4-hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate less than 100 of ≥ 10 seconds) in either study arm during the study period. |
4-hours on either intervention.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Bradycardia <60 beats per minute ≥ 5 seconds
時間枠：4 hours in either intervention.
|
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 5 seconds) in either study arm during the study period. |
4 hours in either intervention.
|
|
Bradycardia <60 beats per minute ≥ 10 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <60 beats per minute ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Bradycardia <80 beats per minute ≥ 5 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Bradycardia <80 beats per minute ≥ 10 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of bradycardia (heart rate <80 beats per minute ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Proportion of time with Bradycardia < 100 beats per minute
時間枠：4 hours on either intervention.
|
The total proportion of time with bradycardia during the study period on either intervention with a heartrate of <100 beats per minute. |
4 hours on either intervention.
|
|
Hypoxemia <85% for ≥ 5 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <85% for ≥ 10 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <85% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <90% for ≥ 5 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <90% for ≥ 10 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <90% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <80% for ≥ 5 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 5 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Hypoxemia <80% for ≥ 10 seconds
時間枠：4 hours on either intervention.
|
The frequency of episodes of hypoxemia (oxygen saturations <80% for ≥ 10 seconds) in either study arm during the study period. |
4 hours on either intervention.
|
|
Proportion of time with hypoxemia < 90%
時間枠：4 hours on either intervention.
|
The total proportion of time with oxygen saturations <90% during the study period on either intervention. |
4 hours on either intervention.
|
|
Bradycardia prediction time
時間枠：4 hours on either intervention.
|
The number of seconds ahead of routine patient monitors at which the device algorithm predicted bradycardia in either group. |
4 hours on either intervention.
|
|
Bradycardia prediction accuracy
時間枠：4 hours on sham control.
|
The area under the curve for the true prediction rate over the false alarm rate in the control group. |
4 hours on sham control.
|
|
Proportion of time with hypoxemia < 85%
時間枠：4 hours on either intervention.
|
The total proportion of time with oxygen saturations <85% during the study period on either intervention. |
4 hours on either intervention.
|
協力者と研究者
捜査官
- 主任研究者：Colm P. Travers Associate Professor of Pediatrics, M.D.、University of Alabama at Birmingham
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- 300008477
- UAB (その他の識別子：UAB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Deidentified individual participant data will be made available upon publication through a data use agreement to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to cptravers@uabmc.edu.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
米国で製造され、米国から輸出された製品。
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