Pinzamiento del cordón con base fisiológica en la hernia diafragmática congénita (PinC)
Pinzamiento del cordón con base fisiológica versus pinzamiento inmediato del cordón para bebés nacidos con hernia diafragmática congénita: un ensayo controlado aleatorizado multicéntrico
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Bonn, Alemania
- Universitätskrankenhaus Bonn
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Mannheim, Alemania
- Universitätsklinik Mannheim
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Melbourne, Australia
- Monash University
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Graz, Austria
- Medical University Graz
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Leuven, Bélgica
- University Hospitals leuven
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Rome, Italia
- Ospedale Pediatrico Bambino Gesu
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Nijmegen, Países Bajos
- Radboudumc University Medical Center
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Rotterdam, Países Bajos
- Erasmus MC University Medical Center - Sophia Children's Hospital
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Stockholm, Suecia
- Karolinska University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Neonatal: mortality before discharge from the tertiary care hospital
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Hernia interna
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Condiciones Patológicas, Anatómicas
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Hernia
- Hipertensión
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Condiciones Patológicas, Signos y Síntomas
- Anomalías congénitas
- Hipertensión Pulmonar
- Hernias Diafragmáticas Congénitas
- Hernia Diafragmática
Otros números de identificación del estudio
- PinC CDH trial
- NL7853 (Identificador de registro: NTR)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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