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CEUS Evaluation of Hydrocephalus in Neonates and Infants

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Aug 1, 2027 → Sep 1, 2027
See other at-risk trials from Children's Hospital of Philadelphia

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Children's Hospital of Philadelphia to Children's Hospital of Philadelphia Show 6 more changesShow less
    • Start date: Aug 15, 2026 to Oct 15, 2026
    • Primary completion pushed from Aug 1, 2027 to Sep 1, 2027
    • Study completion pushed from Aug 1, 2028 to Sep 1, 2028
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site details revised
  2. Start date: Jul 15, 2026 to Aug 15, 2026v15
  3. Primary completion pushed from Aug 1, 2026 to Aug 1, 2027
    • Start date: May 5, 2026 to Jul 15, 2026
    • Study completion pushed from Aug 1, 2027 to Aug 1, 2028
    v14
  4. Start date: Mar 31, 2026 to May 5, 2026v13
  5. Start date: Feb 28, 2026 to Mar 31, 2026v12
Show 10 earlier versionsHide 10 earlier versions
  1. Start date: Jan 15, 2026 to Feb 28, 2026v11
  2. Start date: Dec 1, 2025 to Jan 15, 2026v10
  3. Start date: Oct 1, 2025 to Dec 1, 2025v9
  4. Start date: Sep 1, 2025 to Oct 1, 2025
    • Primary completion date: Jul 1, 2026 to Aug 1, 2026
    • Study completion date: Jul 1, 2027 to Aug 1, 2027
    v8
  5. Start date: Jul 1, 2025 to Sep 1, 2025
    • Site contact updated
    v7
  6. Start date: May 15, 2025 to Jul 1, 2025
    • Primary completion date: May 15, 2026 to Jul 1, 2026
    • Study completion date: May 15, 2027 to Jul 1, 2027
    v6
  7. Start date: Mar 30, 2025 to May 15, 2025
    • Primary completion date: Mar 30, 2026 to May 15, 2026
    • Study completion date: Mar 30, 2027 to May 15, 2027
    • Site contact updated
    v5
  8. Start date: Feb 15, 2025 to Mar 30, 2025
    • Primary completion date: Jan 21, 2026 to Mar 30, 2026
    • Study completion date: Jan 21, 2027 to Mar 30, 2027
    v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 21, 2025 to Feb 15, 2025
    • Site details revised
    v3
  10. Start date: Nov 14, 2024 to Jan 21, 2025v2 Show 5 more changesShow less
    • Primary completion date: Nov 14, 2025 to Jan 21, 2026
    • Study completion date: Nov 14, 2026 to Jan 21, 2027
    • Interventions: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (Drug) to Sulfur Hexafluoride Lipid Type A Microspheres 25 mg Injection Powder for Suspension [LUMASON] (Drug)
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study description expanded, about 3 words
  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.
Hydrocephalus affects up to 2 out of every 500 births and results in long-term disability in up to 78% of those affected. The standard treatment of hydrocephalus is cerebrospinal fluid (CSF) diversion via placement of an invasive ventricular shunt to relieve elevated intracranial pressure (ICP). The clinical decision for CSF diversion is based on the ventricular size and clinical symptoms which are not robust indicators of brain health in neonatal hydrocephalus. The purpose of this study is to assess the safety and feasibility of performing brain contrast-enhanced ultrasound (CEUS) in neonates and infants with diagnosed and/or suspected hydrocephalus.
Trial Details
NCT Number NCT06693752
Lead Sponsor Children's Hospital of Philadelphia
Conditions
(from sponsor)		 Hydrocephalus in Infants, Hydrocephalus Acquired
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov