Clinical Trial

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

Study acronym: DiFuSE
Active, Not Recruiting
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.
Summary
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)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-01-08.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-03-02
Trial Details
NCT Number NCT06200519
Lead Sponsor University College Cork
Conditions Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn, Trisomy 21, Gestational Diabetes
Enrollment 216 participants
Start Date 2024-02-12
Primary Completion 2026-05 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2026-03-04