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Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography

Study acronym: DiFuSE
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 4, 2026 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 400 to confirmed 216
    • Start date changed from estimate of Jan 2024 to Feb 12, 2024
    • Site contact updated
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function. The main question it aims to answer are: * What are the normal reference ranges for parameters of diastolic cardiac function in neonates? * How are these influenced by maternal, intrapartum and neonatal factors? * Do the diastolic changes noted during the first two days of life persist into infancy? Participants will have four echocardiographic assessments in total: * Two during the first 48 hours of life (prior to discharge home) * Two during infancy (as an outpatient)
Trial Details
NCT Number NCT06200519
Lead Sponsor University College Cork
Conditions
(from sponsor)		 Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn, Trisomy 21, Gestational Diabetes
Related terms Diabetes, Gestational, Down Syndrome, Transient Tachypnea of the Newborn
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov