Nasal Intermittent Positive Pressure Ventilation in Premature Infants (NIPPV) (NIPPV)
Efficacy and Safety of NIPPV to Increase Survival Without Bronchopulmonary Dysplasia in Extremely Low Birth Weight Infants
The machines and oxygen used to help very premature babies breathe can have side-effects, such as bronchopulmonary dysplasia (BPD). Infants with BPD get more complications (a higher death rate, a longer time in intensive care and on assisted ventilation, more hospital readmissions in the first year of life, and more learning problems) than infants who do not develop BPD. Doctors try to remove the tube in the wind-pipe that links the baby to the breathing machine as soon as possible. However, small babies get tired, and still require help to breathe. One of the standard and common techniques to help them breathe without a tube in the wind-pipe is to use simple pressure support, nasal continuous positive airway pressure or nCPAP. This supports breathing a little, but it is often not enough to prevent the need to go back on the breathing machine.
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to babies through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy.
The main research question: After being weaned from the breathing machine, is NIPPV better than nCPAP in preventing BPD in premature babies weighing 999 grams or less at birth?
調査の概要
詳細な説明
The immature lung of extremely low birth weight (ELBW, < 1000 g) infants is easily damaged by the placement of an endotracheal tube to deliver mechanical ventilation and oxygen. This and the total time of mechanical ventilation contributes to bronchopulmonary dysplasia (BPD). Infants with BPD have an increased risk of later death or neuro-impairment. With the increasing survival of ELBW infants in the NICU, there has been a proportionate increase in the number of infants surviving with BPD.
Following invasive ventilation via an endotracheal tube (ETT), extubation to nasal Continuous Positive Airway Pressure (nCPAP)ventilation is the standard approach. Currently, 40% of infants who are extubated and given nCPAP support fail, and require re-intubation. Previous work suggests that a less invasive respiratory support such as Nasal Intermittent Positive Pressure Ventilation (NIPPV), without an endotracheal tube is less injurious to the lung. NIPPV may thereby reduce the duration of invasive ventilator support, and aid successful early extubation. We hypothesize that the use of NIPPV leads to a higher rate of survival without BPD than standard therapy with nCPAP.
This randomized clinical trial is appropriately powered to compare NIPPV with nCPAP to detect effects on clinically relevant long-term outcomes, such as death and BPD at 36 weeks. This is a multi-national, randomized, open clinical trial of two different standard methods of providing non-invasive respiratory support to 1000 extremely preterm infants weighing less than 1000 grams at birth.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Dublin、アイルランド
- National Maternity Hospital
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Dublin、アイルランド
- Coombe Women's Hospital
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Cork
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Wilton、Cork、アイルランド
- Cork University Maternity Hospital
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District of Columbia
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Washington、District of Columbia、アメリカ、20037
- The George Washington University Hospital
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Washington、District of Columbia、アメリカ、20007
- Georgetown University Children's Medical Center
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Massachusetts
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Boston、Massachusetts、アメリカ、02215
- Beth Israel Deaconess Medical Center (Bidmc)
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Boston、Massachusetts、アメリカ、02111
- Tufts University Medical Center
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New Jersey
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Voorhees、New Jersey、アメリカ、08043
- Virtua West Jersey Hospital
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New York
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Brooklyn、New York、アメリカ、11203
- Kings County Hospital
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Brooklyn、New York、アメリカ、11023
- SUNY Downstate Medical Center
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Brooklyn、New York、アメリカ、11355
- New York Hospital Queens
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Jamaica、New York、アメリカ、11432
- Queens Hospital Center
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New York、New York、アメリカ、11212
- Brookdale University Hospital & Medical Center
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Stony Brook、New York、アメリカ、11794-8111
- Stony Brook University Medical Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Philadelphia、Pennsylvania、アメリカ、19035
- Pennsylvania Hospital/U. of Pennsylvania
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Utah
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Salt Lake City、Utah、アメリカ、84158-1289
- University of Utah
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Leicester、イギリス、LE1 6TP
- University of Leicester
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London、イギリス、W2 1NY
- St. Mary's Hospital
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Northern Ireland
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Belfast、Northern Ireland、イギリス、BT12 6BB
- Royal Maternity Hospital
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Groningen、オランダ、9700 RB
- University Medical Center Groningen/Beatrix Children's Hosp
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Zwolle、オランダ、8000 GK
- Princess Amalia Dept of Pediatrics, Isala Clinics
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Feldkirch、オーストリア、6800
- LKH Feldkirch
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Doha、カタール
- Hamad Medical Corporation
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Manitoba
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Winnipeg、Manitoba、カナダ
- Winnipeg Health Sciences Centre
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Winnipeg、Manitoba、カナダ、R3E 0L8
- St. Boniface General Hospital/University of Manitoba
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Nova Scotia
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Halifax、Nova Scotia、カナダ
- IWK Health Centre
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Ontario
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Hamilton、Ontario、カナダ、L8S 4J9
- McMaster University
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Ottawa、Ontario、カナダ、K1H 8L1
- Children's Hospital of Eastern Ontario
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Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital General Campus
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Toronto、Ontario、カナダ
- Hospital for Sick Children
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ
- Royal University Hospital
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Singapore、シンガポール、229899
- KK Women's and Children's Hospital
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Stockholm、スウェーデン、S-171 76
- Karolinska University Hospital/Astrid Lingrenn's Children's Hospital
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Rocourt、ベルギー、B-4000
- CHC St. Vincent
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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 <1000 gm
- Gestational age <30 completed weeks
Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either:
- the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support;
- the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
Exclusion Criteria:
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
- Infants who are >28 days old and continue to require mechanical ventilation with an endotracheal tube
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 |
|---|---|
|
アクティブコンパレータ：A
Non-invasive respiratory support via nasal intermittent positive pressure ventilation
|
Deliver non-invasive respiratory support via ventilator with NIPPV device
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アクティブコンパレータ：B
Non-invasive respiratory support via nasal Continuous Positive Airway Pressure
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Deliver non-invasive respiratory support via ventilator with nCPAP device
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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 |
|---|---|
|
Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia
時間枠：36 weeks gestational age
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36 weeks gestational age
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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すべてが妊娠36週で死亡する原因となる
時間枠：妊娠36週
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妊娠36週
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未熟児網膜症
時間枠：退院
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退院
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All cause mortality before first discharge home
時間枠：first discharge home
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first discharge home
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ultrasonographic evidence of brain injury
時間枠：36 weeks gestional age
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36 weeks gestional age
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necrotizing enterocolitis
時間枠：36 weeks gestational age
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36 weeks gestational age
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growth
時間枠：discharge home
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discharge home
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time to establish full feeds
時間枠：discharge home
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discharge home
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nosocomial infections
時間枠：discharge home
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discharge home
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need for re-intubation
時間枠：36 weeks gestational age
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36 weeks gestational age
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time on supplemental oxygen
時間枠：discharge home
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discharge home
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duration of positive pressure respiratory support
時間枠：discharge home
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discharge home
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comparison of synchronized and non-synchronized NIPPV
時間枠：discharge home
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discharge home
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bronchopulmonary dysplasia
時間枠：36 weeks gestational age
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36 weeks gestational age
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air leak syndromes
時間枠：36 weeks gestational age
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36 weeks gestational age
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nasal trauma
時間枠：discharge home
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discharge home
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Haresh Kirpalani, MD, MSc、Hamilton Health Sciences Corporation
- スタディディレクター：Brigitte Lemyre, MD、Children's Hospital of Eastern Ontario
- スタディディレクター：Aaron Chiu, MD、St. Boniface Hospital
- スタディディレクター：David Millar, MD、Royal Maternity Hospital, Belfast
- スタディディレクター：Robin S Roberts, MTech、Hamilton Health Sciences/McMaster University
- スタディディレクター：Bradley Yoder, MD、University of Utah
- スタディディレクター：Peter H Dijk, MD, PhD、University Medical Centrum Groningen
出版物と役立つリンク
一般刊行物
- Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.
- Bamat NA, Guevara JP, Bryan M, Roberts RS, Yoder BA, Lemyre B, Chiu A, Millar D, Kirpalani H. Variation in Positive End-Expiratory Pressure Levels for Mechanically Ventilated Extremely Low Birth Weight Infants. J Pediatr. 2018 Mar;194:28-33.e5. doi: 10.1016/j.jpeds.2017.10.065. Epub 2017 Dec 22.
- Millar D, Lemyre B, Kirpalani H, Chiu A, Yoder BA, Roberts RS. A comparison of bilevel and ventilator-delivered non-invasive respiratory support. Arch Dis Child Fetal Neonatal Ed. 2016 Jan;101(1):F21-5. doi: 10.1136/archdischild-2014-308123. Epub 2015 Jul 10.
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
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。