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

Study acronym: CORDMILK-FU
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 9 of 9 sites
    v13
  2. Primary completion date: Apr 30, 2027 to Aug 30, 2027
    • Study completion date: Jun 30, 2027 to Oct 30, 2027
    v12
  3. Study sites: 8 to 9v11
  4. Study completion date: Sep 30, 2027 to Jun 30, 2027v10
  5. Primary completion date: Dec 31, 2026 to Apr 30, 2027
    • Study completion date: Jun 30, 2027 to Sep 30, 2027
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Jun 16, 2026 to Dec 31, 2026
    • Study completion date: Aug 16, 2026 to Jun 30, 2027
    v8
  2. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Aug 14, 2025 to Jun 16, 2026
    • Study completion date: Aug 14, 2025 to Aug 16, 2026
    • Start date changed from estimate of Aug 15, 2022 to Oct 17, 2022
    • Site details revised at 8 of 8 sites
  3. Start date: Jul 1, 2022 to Aug 15, 2022
    • Primary and study completion dates: May 31, 2026 to Aug 14, 2025
    v6
  4. Start date: Feb 1, 2022 to Jul 1, 2022
    • Primary and study completion dates: Jan 31, 2026 to May 31, 2026
    • Study sites revised (8)
    • Collaborators revised (13)
    v5
  5. Secondary endpoints: details revised at 1 of 1 entryv4
  6. Enrollment target: 350 to 3442v3 Show 9 more changesShow less
    • Primary completion date: May 30, 2020 to Jan 31, 2026
    • Start date: Oct 1, 2018 to Feb 1, 2022
    • Study sites: 3 to 8
    • Study completion date: May 30, 2022 to Jan 31, 2026
    • Secondary endpoints: 2 to 1
    • Collaborators: 2 to 13
    • Eligibility criteria shortened, about 1 word
    • Study description expanded, about 2 words
    • Study title expanded, about 1 word
  7. Secondary endpoints: details revised at 1 of 2 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
An extension of the CORDMILK trial, the CORDMILK follow-up trial will evaluate the neurodevelopmental outcomes at 22-26 months age of term/late preterm infants who were non-vigorous at birth and received umbilical cord milking (UCM) or early cord clamping (ECC).
Trial Details
NCT Number NCT03682042
Lead Sponsor Nemours Children's Clinic
Collaborators: Sharp HealthCare, Thomas Jefferson University, University of California, San Diego, St. Louis University, KLE Academy of Higher Education and Research (Deemed- to- be-University), Jawaharlal Nehru Medical College (JNMC), Belagavi, India, Government Medical College, Nagpur, Daga Memorial Maternity and Children's Hospital, Nagpur, India, Mahatma Gandhi Institute of Medical Sciences, Karnataka Institute of Medical Sciences, Hubbali, India, 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
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