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Physiological-based Cord Clamping in Congenital Diaphragmatic Hernia

Study acronym: PinC
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Jun 1, 2026 to Jan 1, 2026 · Enrollment target: estimated 140 to confirmed 144 · Study completion date changed from estimate of Jul 1, 2026 to Jan 15, 2026 · 4 more Show 7 more changesShow less
    • Primary completion date changed from estimate of Jun 1, 2026 to Jan 1, 2026
    • Enrollment target: estimated 140 to confirmed 144
    • Study completion date changed from estimate of Jul 1, 2026 to Jan 15, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Site details revised at 1 of 9 sites
    • Publications: details revised at 2 of 2 entries
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 9 of 9 sitesv12 Show 1 more changeShow less
    • Site details revised at 9 of 9 sites
  3. Primary completion date: Jun 1, 2025 to Jun 1, 2026 Completion date: Jul 1, 2025 to Jul 1, 2026 · Site contacts updated at 2 of 9 sitesv11 Show 2 more changesShow less
    • Completion date: Jul 1, 2025 to Jul 1, 2026
    • Site contacts updated at 2 of 9 sites
  4. Primary completion date: Jun 1, 2024 to Jun 1, 2025 Completion date: Jul 1, 2024 to Jul 1, 2025 · Site details revised at 5 of 9 sitesv10 Show 2 more changesShow less
    • Completion date: Jul 1, 2024 to Jul 1, 2025
    • Site details revised at 5 of 9 sites
  5. Primary completion date: Jun 1, 2023 to Jun 1, 2024 Study sites: 6 to 9 · Completion date: Jul 1, 2023 to Jul 1, 2024 · Secondary endpoints: 28 to 7v9 Show 3 more changesShow less
    • Study sites: 6 to 9
    • Completion date: Jul 1, 2023 to Jul 1, 2024
    • Secondary endpoints: 28 to 7

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 5 to 6v8
  2. Site details revised at 2 of 5 sitesv7
  3. Study sites: 3 to 5v6
  4. Study sites: 2 to 3v5
  5. Secondary endpoints: 9 to 28v4 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 1 of 2 sitesv3
  7. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 1, 2020 to May 11, 2020 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Jun 1, 2020 to May 11, 2020
    • Site details revised at 2 of 2 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04373902
Lead Sponsor Erasmus Medical Center
Conditions Hernias, Diaphragmatic, Congenital, Hernia; Diaphragm Defect, Congenital, Pulmonary Hypertension
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov