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

Gestational Diabetes Clinical Trial

Official 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

Status Not yet recruiting

Clinical Trial 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)

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Diseases
• Diabetes, Gestational
• Diastolic Dysfunction
• Down Syndrome
• Gestational Diabetes
• Neonatal Encephalopathy
• Small for Gestational Age at Delivery
• Tachypnea
• Transient Tachypnea of the Newborn
• Trisomy 21

• NCT number: NCT06200519
• Study type: Observational
• Source: University College Cork
• Contact: Eugene Dempsey
• Phone: +353214920525
• Email: g.dempsey@ucc.ie
• Status: Not yet recruiting
• Start date: January 2024
• Completion date: July 2026