先天性横隔膜ヘルニアにおける生理学的コードクランプ (PinC)
先天性横隔膜ヘルニアで生まれた乳児に対する生理学的ベースの臍帯クランプと即時臍帯クランプ：多施設無作為対照試験
Pulmonary hypertension is a major determinant of postnatal survival in infants with a congenital diaphragmatic hernia (CDH). The current care during the perinatal stabilisation period in infants born with this rare birth defect might contribute to the development of pulmonary hypertension after birth - in particular umbilical cord clamping before lung aeration. An ovine model of diaphragmatic hernia demonstrated that cord clamping after lung aeration, called physiological-based cord clamping (PBCC), avoided the initial high pressures in the lung vasculature while maintaining adequate blood flow, thereby avoiding vascular remodelling and aggravation of pulmonary hypertension. The investigators aim to investigate if the implementation of PBCC in the perinatal stabilisation period of infants born with a CDH could reduce the incidence of pulmonary hypertension in the first 24 hours after birth.
The investigators will perform a multicentre, randomised controlled trial in infants with an isolated CDH. Before birth, infants will be randomised to either PBCC or immediate cord clamping, stratified by treatment centre and severity of pulmonary hypoplasia on antenatal ultrasound. For performing PBCC a purpose-designed resuscitation module (the Concord Birth Trolley) will be used.
調査の概要
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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Rome、イタリア
- Ospedale Pediatrico Bambino Gesu
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Nijmegen、オランダ
- Radboudumc University Medical Center
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Rotterdam、オランダ
- Erasmus MC University Medical Center - Sophia Children's Hospital
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Melbourne、オーストラリア
- Monash University
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Graz、オーストリア
- Medical University Graz
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Stockholm、スウェーデン
- Karolinska University Hospital
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Bonn、ドイツ
- Universitätskrankenhaus Bonn
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Mannheim、ドイツ
- Universitätsklinik Mannheim
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Leuven、ベルギー
- University Hospitals leuven
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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:
- Left-sided CDH
- Isolated CDH: no associated structural or genetic abnormalities that are diagnosed before birth
- Gestational age at delivery ≥35.0 weeks
- Parental written informed consent
Exclusion Criteria:
- Right-sided or bilateral CDH
- Gestational age at delivery <35.0 weeks
- Maternal contraindications: anterior placenta praevia, placental abruption
- High urgency caesarean section, with intended interval to delivery <15 min
- Cases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension
- Twin pregnancies in which the infant diagnosed with a CDH is born first
- Multiple birth >2 (triplets or higher order)
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：Physiological-based cord clamping
In PBCC, the Concord will be placed next to the bed of the mother and all equipment will be checked before the second stage of labour has started. The infant will be placed on the platform of the Concord immediately after birth, avoiding any traction or pressure on the cord and avoiding heat loss by radiation heating. The umbilical cord will not be clamped until the infant is considered respiratory stable, which is defined as the presence of a heart rate >100 bpm and preductal oxygen saturation >85%, while using an fraction of inspired oxygen (FiO2) of <0.5. The minimum and maximum times of cord clamping are three and ten minutes after birth, respectively. Oxytocin administration will be postponed until after cord clamping if there are no obstetric concerns. At any time, the attending neonatologist and obstetrician can decide that PBCC should not be performed or be interrupted. In that case, the infant can be placed on the standard resuscitation table for (further) stabilisation. |
See 'Arm' |
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介入なし：Immediate cord clamping
In the immediate cord clamping group, the cord will be clamped immediately after birth. The infant will then be transferred to the standard neonatal resuscitation table. After cord clamping, all infants will be managed according to the standardised neonatal management protocol for infants with a CDH, which is a consensus of current clinical guidelines by the CDH EURO consortium. |
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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Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
時間枠：First 24 hours after birth
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Pulmonary hypertension is present if at least 2 of the following 4 criteria are present or if the infant requires extracorporeal membrane oxygenation (ECMO) in the first 24 hours after birth:
The following echocardiographic parameters will be collected to objectify these criteria:
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First 24 hours after birth
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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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Neonatal: mortality before discharge from the tertiary care hospital
時間枠：From birth till discharge from the tertiary care hospital, through study completion an average of one year
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Number of patients that died before discharge |
From birth till discharge from the tertiary care hospital, through study completion an average of one year
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Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
時間枠：The first 24 hours after delivery
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Number of patients with 3 or more criteria or ECMO |
The first 24 hours after delivery
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Neonatal: number of patients requiring ECMO therapy
時間枠：From admission to the ICU until the date of death or the date of discharge home, whichever came first
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Number of patients requiring ECMO therapy |
From admission to the ICU until the date of death or the date of discharge home, whichever came first
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Neonatal: number of days of duration of supplemental oxygen need
時間枠：From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Number of days of duration of supplemental oxygen need |
From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Neonatal: number of days of duration of mechanical ventilation
時間枠：From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Number of days of duration of mechanical ventilation |
From admission to the ICU until the date of discharge to another ward or home, whichever came first,through study completion an average of one year
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Neonatal: duration of admission to the tertiary care hospital
時間枠：From admission to the ICU until the date of discharge to another ward or home, whichever came first
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Number of days of admission to the tertiary care hospital |
From admission to the ICU until the date of discharge to another ward or home, whichever came first
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Maternal: number of patients with postpartum haemorrhage
時間枠：The first 24 hours after delivery
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Postpartum haemorrhage is defined as estimated blood loss >1000 mL |
The first 24 hours after delivery
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Horn-Oudshoorn EJJ, Knol R, Vermeulen MJ, Te Pas AB, Hooper SB, Cochius-den Otter SCM, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Reiss IKM, DeKoninck PLJ. Physiological-based cord clamping versus immediate cord clamping for infants born with a congenital diaphragmatic hernia (PinC): study protocol for a multicentre, randomised controlled trial. BMJ Open. 2022 Mar 18;12(3):e054808. doi: 10.1136/bmjopen-2021-054808.
- Horn-Oudshoorn EJJ, Vermeulen MJ, Knol R, Bout-Rebel R, Te Pas AB, Hooper SB, Otter SCMC, Wijnen RMH, Crossley KJ, Rafat N, Schaible T, de Boode WP, Debeer A, Urlesberger B, Roberts CT, Kipfmueller F, Capolupo I, Burgos CM, Hansen BE, Reiss IKM, DeKoninck PLJ. Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan. Trials. 2024 Mar 20;25(1):198. doi: 10.1186/s13063-024-08027-7.
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 (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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- PinC CDH trial
- NL7853 (レジストリ識別子：NTR)
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?
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
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