Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age (CORSAD)
A Randomised Controlled Trial of Delivery Room Intubation Rates Comparing a New System and T-piece Resuscitation System for Initial Stabilisation of Infants Born <28 Weeks
Trial purpose: For infants born <28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)?
Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born <28 weeks.
調査の概要
状態
詳細な説明
The study is a two arm randomised comparison of two systems (T-piece device and the new system) for respiratory support after delivery of an infant born less than 28 weeks gestational age (GA). This multicentre trial will start at Karolinska University Hospital and other sites can join throughout the study period. The trial is academic with the coordinating investigator as sponsor. No company funding will be considered.
The new device has been designed for neonatal resuscitation and CE-marked for this intended use. The device is operated/handled in a similar way to existing devices and can provide support according to resuscitation guidelines.
During spontaneous breathing the continuous positive airway pressure (CPAP) provided with the new system is more pressure stable and has low imposed work of breathing. The benefits of decreased imposed work of breathing during resuscitation have not previously been investigated. The new system has the option of using prongs as the patient interface. Prongs have shown promising results in trials and have theoretical benefits. We hypothesis that the combined use of prongs and low imposed work of breathing could reduce the number of infants that need mechanical ventilation.
Screening for eligibility and consent will be performed on mothers with threatening delivery of an extremely premature infant (<28 weeks gestational age). There is no lower gestational age limit but patients should not be included if there is a decision to intubate prior to delivery or treatment limitations.
After a patient has been enrolled the randomisation will be on hold until delivery is imminent. Randomisation will be stratified on centre, gestational age and antenatal steroid treatment. The interventions cannot be blinded.
The management of respiratory support is according to international guidelines and a detailed description is provided in the clinical management appendix. The intervention is respiratory support for the first 10-30 minutes of life and will begin after birth when the infant is transferred to the resuscitation team. The intervention ends 1) when an infant is intubated (primary outcome), 2) after a minimum of 10 minutes support, with the randomized system, the patient is stable and breathing adequately, 3) at 30 minutes when the respiratory support can continue as decided by the clinicians (cross-over not allowed).
Apart from the system used for respiratory support all patients will receive standard care. No assessments or investigations of the trial subjects are planned. Data will be reported by the resuscitation team and collected from records.
The primary outcome is delivery room intubation or death. The secondary outcomes include time to intubation, use of surfactant, use of positive pressure ventilation, respiratory support at 72 hours and temperature on intensive care admission. Safety variables include pneumothorax, intraventricular haemorrhage and problems with ventilation and equipment.
All analysis will be on intention to treat and p<0.05 considered statistically significant. The primary outcome variable (delivery room intubation or death) will represent a 2x2 cross table and analysed with Pearson chi-square test. The secondary outcomes include Kaplan Meier analysis of time to intubation and comparisons of means for continuous variables. There are no predetermined subgroups. Subgroup analysis will be used to describe the population and to generate hypotheses.
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
-
-
-
Reykjavík、アイスランド、101
- Department of neonatology, University Hospital of Iceland
-
-
-
-
-
Linköping、スウェーデン、58185
- University Hospital Linköping, Department of Pediatrics
-
Stockholm、スウェーデン、171 76
- Karolinska University Hospital, Neonatology department
-
-
-
-
-
Stavanger、ノルウェー、4011
- Stavanger University Hospital, Department of Pediatrics
-
-
-
-
-
Poznan、ポーランド、60-535
- Department of Neonatology, Poznan University of Medical Sciences
-
-
-
-
-
Vilnius、リトアニア、LT-08406
- Neonatal Unit, Vilnius University Hospital Santaros Klinikos
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Born <28 weeks gestational age at a university hospital
- Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given
Exclusion Criteria:
- Decision on treatment limitations before randomisation
- Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
- Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
- Known neuromuscular disease
- No study neonatologist available
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：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：Reference Device: T-piece System
|
Infants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol).
Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
他の名前：
|
|
アクティブコンパレータ：Investigational Device: The New System
|
Infants will receive support by the new system (manufactured by Inspiration Healthcare, UK).
Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
他の名前：
|
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 |
|---|---|---|
|
Delivery room intubation or death
時間枠：0-30 minutes
|
The primary outcome is delivery room intubation or death.
Death has to be included in the primary outcome since patients that die may not always be intubated.
The variable is a dichotomous outcome and reported by the resuscitation team.
|
0-30 minutes
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to primary outcome (intubation or death)
時間枠：up to 72 hours of age
|
The time (minutes:hours) that a patient reach primary outcome.
Data reported by resuscitation team or collected at patient record review of the first three days of life.
This is a safety endpoint.
|
up to 72 hours of age
|
|
Death
時間枠：up to 72 hours of age
|
The time (minutes:hours) that a patient died.
Data reported by resuscitation team or collected at patient record review of the first three days of life.
This is a safety endpoint.
|
up to 72 hours of age
|
|
Intra ventricular haemorrhage grade III or more
時間枠：up to 72 hours of age
|
The number of patients with an intra ventricular hemorrhage grade III or more.
Data collected at patient record review of the first three days of life.
This is a safety endpoint.
|
up to 72 hours of age
|
|
Airleaks and pneumothorax
時間枠：up to 72 hours of age
|
The number of patients with airleaks or pneumothorax during resuscitation or the first 72 hours of life.
Data reported by resuscitation team or collected at patient record review of the first three days of life.
This is a safety endpoint.
|
up to 72 hours of age
|
|
Failed ventilation
時間枠：0-30 minutes
|
The number of patients with failed ventilation during resuscitation.
Data reported by resuscitation team.
This is a safety endpoint.
|
0-30 minutes
|
|
Device problems or malfunction
時間枠：0-30 minutes
|
The instances that there was a problem with the randomized intervention.
Data reported by resuscitation team.
This is a safety endpoint.
Device problems or malfunction activates the adverse events handling protocol.
|
0-30 minutes
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Surfactant use in delivery room (DR) and neonatal intensive care unit (NICU)
時間枠：up to 72 hours of age
|
The number of patients, method used and the number of doses that a patient received in the DR and NICU.
Data reported by resuscitation team or collected at patient record review of the first three days of life.
|
up to 72 hours of age
|
|
The use of positive pressure ventilation (PPV) in delivery room
時間枠：0-30 minutes
|
The number of patients that needed PPV during resuscitation.
Data reported by resuscitation team.
|
0-30 minutes
|
|
Use of sustained inflation (not recommended)
時間枠：0-30 minutes
|
The number of patients that were treated with a sustained inflation during resuscitation.
This is not recommended and a violation of protocol.
Data reported by resuscitation team.
|
0-30 minutes
|
|
Reason for DR intubation
時間枠：0-30 minutes
|
The main reason for intubating patients in the DR during resuscitation.
Data reported by resuscitation team.
|
0-30 minutes
|
|
Response to resuscitation measured by APGAR at 1, 5 and 10 minutes
時間枠：1-10 minutes
|
The initial status of the patient and response to resuscitation measured by APGAR-scores (0-2 points on the five standard criteria).
Data reported by resuscitation team.
|
1-10 minutes
|
|
Inspired oxygen level, oxygen saturation (SpO2) and level of CPAP support at 5 and 10 minutes
時間枠：5-10 minutes
|
The initial status of the patient and response to resuscitation measured by need for oxygen (%), SpO2 (%) and the level of CPAP support (cm H2O).
Data reported by resuscitation team.
|
5-10 minutes
|
|
Patient temperature on NICU admission
時間枠：10-180 minutes
|
The temperature of the patients when they arrive to NICU (°C).
Data collected at patient record review of the first three days of life.
|
10-180 minutes
|
|
Reason for NICU intubation
時間枠：up to 72 hours of age
|
The main reason for intubating patients in the NICU.
Data collected at patient record review of the first three days of life.
|
up to 72 hours of age
|
|
Mechanical ventilation at any time <72 h
時間枠：up to 72 hours of age
|
The number of patients that has received mechanical ventilation at any time <72 hours.
Data collected at patient record review of the first three days of life.
|
up to 72 hours of age
|
|
Mechanical ventilation or mode of non-invasive support at 72 h
時間枠：at 72 hours of age
|
The number of patients that had mechanical ventilation or non-invasive support at three days of age (including type of support).
Data collected at patient record review of the first three days of life.
|
at 72 hours of age
|
|
Decisions on treatment limitations during resuscitation
時間枠：0-30 minutes
|
The number of patients that had any decision on limitations of treatment during resuscitation.
Data reported by resuscitation team.
|
0-30 minutes
|
|
Withdrawal or withholding treatment
時間枠：up to 72 hours of age
|
The number of patients that had any decision on withdrawal or withholding treatment in the DR or NICU.
Data collected at patient record review of the first three days of life.
|
up to 72 hours of age
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Baldvin Jonsson, MD, PhD、Karolinska Institutet
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (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。