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

January 8, 2024 updated by: Dr. Gene Dempsey, University College Cork

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

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)

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
      • Cork, Ireland, T12 DC4A
        • Cork University Maternity Hospital
        • Contact:
          • Gene Dempsey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All neonates greater than or equal to 35 weeks gestational age at birth and who meet the inclusion and exclusion criteria in Table 1 below will be considered for inclusion. Informed consent will be obtained from the parent prior to inclusion.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Neonates born at 35 weeks gestation and above

Stratification of population for recruitment and data analysis

  1. Gestational age in weeks
  2. Birth weight and centile
  3. Small for gestational age (birth weight <10th centile post-natal)
  4. Large for gestational age (birth weight >90th centile post-natal)
  5. Evidence of antenatal Doppler abnormalities
  6. Maternal gestational diabetes mellitus or pre-existing diabetes mellitus
  7. Maternal pre-eclampsia
  8. Signs of maternal chorioamnionitis
  9. Mode of delivery
  10. Transient Tachypnea of Newborn
  11. Pregnancy conceived by assisted reproductive technologies
  12. Maternal medication use
  13. Suspected or confirmed Trisomy 21
  14. Gestational age at birth 35-36+6 gestation group
  15. Feeding type
  16. Mild neonatal encephalopathy
  17. Moderate and severe neonatal encephalopathy receiving therapeutic hypothermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 and Day 2 of life
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.
6 - 9 months of life, 12 - 18 months of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Investigators

  • Principal Investigator: Eugene Dempsey, University College Cork

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiFuSE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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