Clampaggio del cordone su base fisiologica nell'ernia diaframmatica congenita (PinC)
Clampaggio del cordone su base fisiologica rispetto al clampaggio immediato del cordone nei neonati nati con ernia diaframmatica congenita: uno studio multicentrico, randomizzato e controllato
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Melbourne, Australia
- Monash University
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Graz, Austria
- Medical University Graz
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Leuven, Belgio
- University Hospitals leuven
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Bonn, Germania
- Universitätskrankenhaus Bonn
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Mannheim, Germania
- Universitätsklinik Mannheim
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Rome, Italia
- Ospedale Pediatrico Bambino Gesu
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Nijmegen, Olanda
- Radboudumc University Medical Center
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Rotterdam, Olanda
- Erasmus MC University Medical Center - Sophia Children's Hospital
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Stockholm, Svezia
- Karolinska University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Nessun intervento: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Neonatal: mortality before discharge from the tertiary care hospital
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Ernia interna
- Malattie vascolari
- Malattia cardiovascolare
- Condizioni patologiche, anatomiche
- Malattie delle vie respiratorie
- Malattie polmonari
- Ernia
- Ipertensione
- Malattie e anomalie congenite, ereditarie e neonatali
- Condizioni patologiche, segni e sintomi
- Anomalie congenite
- Ipertensione, polmonare
- Ernie, diaframmatiche, congenite
- Ernia, diaframmatica
Altri numeri di identificazione dello studio
- PinC CDH trial
- NL7853 (Identificatore di registro: NTR)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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