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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diastolic Dysfunction Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Mellitus Diabetes, Gestational Down Syndrome Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gestational Diabetes Glucose Metabolism Disorders Infant, Newborn, Diseases Infant, Premature, Diseases Intellectual Disability Lung Diseases Metabolic Diseases Neonatal Encephalopathy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Small for Gestational Age at Delivery Tachypnea Transient Tachypnea of the Newborn Trisomy 21 Urogenital Diseases

Age range

6 hour–18 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Maternity Hospital

Cork, T12 DC4A, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Reference values for diastolic function parameters in neonates

Time frame: Day 1 and Day 2 of life

Establish 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 infancy

Time frame: 6 - 9 months of life, 12 - 18 months of life

Assess whether the diastolic function changes noted in the first few days persist over time.

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Registry information

Official study title

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

Acronym: DiFuSE

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jan 11, 2024
Registry last updated: Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting