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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06200519
Acronym
DiFuSE
Enrollment
216
Registered
2024-01-11
Start date
2024-02-12
Completion date
2026-07-01
Last updated
2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Gestational Diabetes, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn, Trisomy 21

Keywords

Diastolic function, Neonatal transition, Longitudinal, Tissue Doppler imaging, Speckle tracking echocardiography

Brief 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.

Interventions

None listed

Sponsors

University College Cork
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Birth at 35 weeks gestation or above * Informed consent obtained

Exclusion criteria

* Any apparent congenital anomalies * Any known chromosomal abnormalities (except Trisomy 21) * Any known congenital structural heart disease (except patent ductus arteriosus, atrial septal defect, patent foramen ovale or ventricular septal defect)

Design outcomes

Primary

MeasureTime frameDescription
Reference values for diastolic function parameters in neonatesDay 1 and Day 2 of lifeEstablish reference values for conventional and novel echocardiographic methods of assessing diastolic function in neonates and stratify them by different antenatal, intrapartum, maternal and neonatal factors to assess whether there is an association between these factors and cardiac function.
Persistence of diastolic function changes into infancy6 - 9 months of life, 12 - 18 months of lifeAssess whether the diastolic function changes noted in the first few days persist over time.

Countries

Ireland

Contacts

PRINCIPAL_INVESTIGATOREugene Dempsey

University College Cork

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026