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

Not yet recruiting

• Conditions: Neonatal Encephalopathy; Gestational Diabetes; Transient Tachypnea of the Newborn; Trisomy 21; Diastolic Dysfunction; Small for Gestational Age at Delivery

• Registration Number: NCT06200519
• Lead Sponsor: University College Cork

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.

Study Timeline

• Study First Submitted: 2023-12-21
• Status Verified: 2024-01
• Study Start: 2024-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-11
• Last Update Posted: 2024-01-11
• Primary Completion: 2026-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reference values for diastolic function parameters in neonates	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	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.

Trial Locations

Locations (1)

Cork University Maternity Hospital; 🇮🇪 Cork, Ireland