Avoiding Hypotension in Preterm Neonates (AHIP)
Avoiding Hypotension in Preterm Neonates (AHIP) - A Randomised Controlled Study on Near Infrared Spectroscopy Monitoring of Peripheral-muscle and Cerebral Oxygenation With Defined Interventions Versus Routine Monitoring and Treatment in Preterm Neonates
Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number of hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared spectroscopy in combination with predefined interventions and secondly to explore the potential impact on cerebral injury and mortality.
Hypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation ratio investigators will reduce hypotensive episodes and use of catecholamines which will reduce cerebral injury and mortality.
Methods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300) will be measured for 24h starting <6 hours postpartum. When cTOI/pTOI ratio increases >5% within a 6h period, predefined interventions will be performed.
Primary outcome parameter will be duration of hypotensive episodes and use of catecholamines during the first 48h after birth. Secondary outcome parameters will be cerebral injury and mortality.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Styria
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Graz、Styria、オーストリア、8036
- Dep. of Pediatrics, Medical University of Graz
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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:
- preterm neonates
- decision to conduct full life support
- written informed consent
- age <6 hours
- no use of catecholamines before start of NIRS measurements
Exclusion Criteria:
- no decision to conduct full life support
- no written informed consent
- age >6 hours
- use of catecholamines before start of NIRS measurements
- congenital malformation
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：防止
- 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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実験的：NIRS visible and predefined interventions
NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases >5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.
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NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases >5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.
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他の：NIRS not visible and treatment as usual
NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual')
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NIRS not visible and the patients will be treated according to routine
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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 |
時間枠 |
|---|---|
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Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours
時間枠：48 hours
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48 hours
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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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Cerebral injury by cerebral ultrasound
時間枠：up to 16 weeks
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From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.
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up to 16 weeks
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Mortality
時間枠：up to 16 weeks
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up to 16 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neonatal morbidities
時間枠：up to 16 weeks
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From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.
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up to 16 weeks
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Heart rate
時間枠：48 hours
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48 hours
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Blood pressure
時間枠：48 hours
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48 hours
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Arterial oxygen saturation
時間枠：48 hours
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48 hours
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協力者と研究者
捜査官
- 主任研究者：Gerhard Pichler, MD、Dep. of Pediatrics, Medical University of Graz
出版物と役立つリンク
一般刊行物
- Hoeller N, Baik-Schneditz N, Schwaberger B, Mileder L, Urlesberger B, Pichler G. Cerebral and peripheral muscle oxygenation and perfusion: Course in moderate and late preterm neonates during the first day after birth. Physiol Int. 2020 Jul 17;107(2):267-279. doi: 10.1556/2060.2020.00028.
- Pichler G, Holler N, Baik-Schneditz N, Schwaberger B, Mileder L, Stadler J, Avian A, Pansy J, Urlesberger B. Avoiding Arterial Hypotension in Preterm Neonates (AHIP)-A Single Center Randomised Controlled Study Investigating Simultaneous Near Infrared Spectroscopy Measurements of Cerebral and Peripheral Regional Tissue Oxygenation and Dedicated Interventions. Front Pediatr. 2018 Feb 1;6:15. doi: 10.3389/fped.2018.00015. eCollection 2018.
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
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