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Fysiologisk-basert ledningsklemming i medfødt diafragmabrokk (PinC)

22. september 2026 oppdatert av: Philip L.J. DeKoninck, Erasmus Medical Center

Fysiologisk-basert snorklemming versus umiddelbar snorklemming for spedbarn født med medfødt diafragmabrokk: et multisenter, randomisert kontrollert forsøk

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

144

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Melbourne, Australia
        • Monash University
  • Belgia
      • Leuven, Belgia
        • University Hospitals leuven
  • Italia
      • Rome, Italia
        • Ospedale Pediatrico Bambino Gesu
  • Nederland
      • Nijmegen, Nederland
        • Radboudumc University Medical Center
      • Rotterdam, Nederland
        • Erasmus MC University Medical Center - Sophia Children's Hospital
  • Sverige
      • Stockholm, Sverige
        • Karolinska University Hospital
  • Tyskland
      • Bonn, Tyskland
        • Universitätskrankenhaus Bonn
      • Mannheim, Tyskland
        • Universitätsklinik Mannheim
  • Østerrike
      • Graz, Østerrike
        • Medical University Graz

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 måneder og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: Physiological-based cord clamping

See 'Arm'
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with pulmonary hypertension diagnosed in the first 24 hours after birth.
Tidsramme: First 24 hours after birth

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:

  1. Right ventricular systolic pressure (RVSP) ≥2/3 systemic systolic pressure*
  2. Right ventricle (RV) dilatation/septal displacement or RV dysfunction +/- left ventricle (LV) dysfunction*
  3. Pre-post ductal SpO2 difference >10% for at least 15 consecutive minutes
  4. Oxygenation Index >20** *as found on first ultrasound in first 24 hours after birth; **highest value measured in first 24 hours after birth

The following echocardiographic parameters will be collected to objectify these criteria:

  • RV size
  • Pulmonary artery acceleration time (PAAT), right ventricular ejection time (RVET), PAAT:RVET ratio
  • Intraventricular septum configuration
  • LV systolic eccentricity index
  • Mean airway pressure
  • PaO2
  • FiO2
  • Preductal+postductal SpO2
First 24 hours after birth

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Neonatal: mortality before discharge from the tertiary care hospital
Tidsramme: From birth till discharge from the tertiary care hospital, through study completion an average of one year

Number of patients that died before discharge
From birth till discharge from the tertiary care hospital, through study completion an average of one year
Neonatal: presence of 3 or more criteria for pulmonary hypertension or extracorporeal membrane oxygenation within 24 hours after birth
Tidsramme: The first 24 hours after delivery

Number of patients with 3 or more criteria or ECMO
The first 24 hours after delivery
Neonatal: number of patients requiring ECMO therapy
Tidsramme: From admission to the ICU until the date of death or the date of discharge home, whichever came first

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
Neonatal: number of days of duration of supplemental oxygen need
Tidsramme: 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

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
Neonatal: number of days of duration of mechanical ventilation
Tidsramme: 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

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
Neonatal: duration of admission to the tertiary care hospital
Tidsramme: From admission to the ICU until the date of discharge to another ward or home, whichever came first

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
Maternal: number of patients with postpartum haemorrhage
Tidsramme: The first 24 hours after delivery

Postpartum haemorrhage is defined as estimated blood loss >1000 mL
The first 24 hours after delivery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Erasmus Medical Center

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. mai 2020

Primær fullføring (Faktiske)

1. januar 2026

Studiet fullført (Faktiske)

15. januar 2026

Datoer for studieregistrering

Først innsendt

14. april 2020

Først innsendt som oppfylte QC-kriteriene

30. april 2020

Først lagt ut (Faktiske)

5. mai 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PinC CDH trial
  • NL7853 (Registeridentifikator: NTR)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

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Nei

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