Serial Brain MRI in Hospitalized Preterm Infants

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 1, 2026 → Sep 1, 2027
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Record History

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  1. Primary completion pushed from Sep 1, 2026 to Sep 1, 2027 Show 6 more changesShow less
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Interventions: Reference/ Standard of care (Other), SENSE-plus: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program… to Reference/ Standard of care (Other), SENSE-plus: The Supporting and Enhancing NICU Sensory Experiences 2nd Edition (SENSE II) program…
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
    • Publications: details revised at 8 of 8 entries
  2. Re-verified, no change to tracked fieldsv4
  3. Study completion date: Sep 14, 2028 to Sep 14, 2029v3
  4. Primary completion date: Sep 14, 2024 to Sep 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Sep 14, 2027 to Sep 14, 2028
    • Site details revised
    v2
  5. Study First Submitted
  • 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 purpose of this research study is to use serial magnetic resonance imaging (MRI) to define the timing and factors associated with brain injury as well as the pattern of brain growth of very preterm infants during hospitalization in the neonatal intensive care unit (NICU). In addition, the goal is to utilize early MRI to risk-stratify preterm infants and tailor rehabilitative interventions according to risk in order to explore associations between NICU rehabilitative intervention and short- and long-term outcomes of preterm infants.
Trial Details
NCT Number NCT06052865
Lead Sponsor Brigham and Women's Hospital
Collaborators: POM Wonderful LLC
Conditions
(from sponsor)		 Preterm Birth Complication
Related terms Brain Injuries, Premature Birth
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov