Trials / Active Not Recruiting

Active Not RecruitingNCT06200519

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

A Longitudinal Observational Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography in Neonates Born at 35 Weeks Gestation or Above

Status: Active Not Recruiting
Phase: —
Study type: Observational
Enrollment: 216 (actual)

Sponsor: University College Cork · Academic / Other
Sex: All
Age: 6 Hours – 18 Hours
Healthy volunteers: Accepted

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)

Detailed description

Participants will have their first echo to assess diastolic function, using both conventional and novel echocardiographic measure, within the first 6 to 18 hours of life approximately (Day 1 scan) and this will be repeated at 30 to 42 hours of life (Day 2 scan). Both scans will involve a comprehensive structural assessment to confirm normal anatomy. All participants will be invited to return for follow-up targeted echocardiography assessments to evaluate function at approximately 6 - 9 months (Scan 3) and at approximately 12 - 18 months of life (Scan 4). At each of these visits, their weight, height, any interim hospital admissions, serious illnesses or medical issues and medications will be documented using a structured checklist format.

Conditions

Timeline

Start date: 2024-02-12
Primary completion: 2026-05-01
Completion: 2026-07-01
First posted: 2024-01-11
Last updated: 2026-03-04

Locations

1 site across 1 country: Ireland

Source: ClinicalTrials.gov record NCT06200519. Inclusion in this directory is not an endorsement.