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Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries

Study acronym: CORDMILK
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study completion pushed from Jun 28, 2026 to Oct 31, 2026v13
  2. Minor Study completion date: Feb 28, 2026 to Jun 28, 2026v12
  3. Minor Study completion date: Nov 30, 2025 to Feb 28, 2026v11
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 31, 2025 to Sep 1, 2025
    • Study completion date: Aug 31, 2025 to Nov 30, 2025
    • Site details revised at 9 of 9 sites
    v10
  5. Minor Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Primary and study completion dates: Jun 16, 2025 to Aug 31, 2025v8
  2. Notable Primary and study completion dates: Jun 16, 2024 to Jun 16, 2025
    • Study sites: 8 to 9
    • Secondary endpoints: 3 to 1
    v7
  3. Minor Re-verified, no change to tracked fieldsv6
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Aug 14, 2023 to Jun 16, 2024
    • Start date changed from estimate of Aug 15, 2022 to Oct 17, 2022
    • Site details revised at 8 of 8 sites
    v5
  5. Notable Start date: Jul 1, 2022 to Aug 15, 2022
    • Primary and study completion dates: May 31, 2023 to Aug 14, 2023
    v4
  6. Notable Start date: Feb 1, 2022 to Jul 1, 2022
    • Primary and study completion dates: Jan 31, 2023 to May 31, 2023
    • Study sites revised (8)
    • Collaborators: 12 to 14
    v3
  7. Notable Phase: Phase 3 to Not applicablev2 Show 10 more changesShow less
    • Enrollment target: 1400 to 3442
    • Primary completion date: May 30, 2020 to Jan 31, 2023
    • Start date: Oct 1, 2018 to Feb 1, 2022
    • Study sites: 3 to 8
    • Study completion date: May 30, 2022 to Jan 31, 2023
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description expanded, about 170 words
    • Collaborators: 2 to 12
    • Study title revised
    • Eligibility criteria shortened, about 4 words
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators will conduct a study on non-vigorous infants at birth to determine if umbilical cord milking (UCM) results in lower rate of moderate to severe hypoxic ischemic encephalopathy (HIE) or death than early clamping and for infants who are non-vigorous at birth and need immediate resuscitation.
Trial Details
NCT Number NCT03657394
Lead Sponsor Nemours Children's Clinic
Collaborators: Sharp HealthCare, Thomas Jefferson University, University of San Diego, St. Louis University, Jawaharlal Nehru Medical College, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences, Karnataka Institue of Medical Sciences, Hubbali, India, Jawaharlal Institute of Postgraduate Medical Education & Research, All India Institute of Medical Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Indira Gandhi Government Medical College & Hospital, Nagpur, India, Pimpri Chinchwad Municipal Corporation's Post-Graduate Institute, Yashwantrao Chavan Memorial Hospital, Pune, India, Government Medical College, Nagpur
Conditions
(from sponsor)
Hypoxic-Ischemic Encephalopathy, Birth Asphyxia
Related terms Asphyxia Neonatorum, Fetofetal Transfusion, Hypoxia-Ischemia, Brain
Enrollment 3,442 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov