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

U

University College Cork (UCC)

Status

Not yet enrolling

Conditions

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

Study type

Observational

Funder types

Other

Identifiers

NCT06200519
DiFuSE

Details and patient eligibility

About

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)

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

6 to 18 hours old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

400 participants in 1 patient group

Neonates born at 35 weeks gestation and above
Description:
Stratification of population for recruitment and data analysis Gestational age in weeks Birth weight and centile Small for gestational age (birth weight <10th centile post-natal) Large for gestational age (birth weight >90th centile post-natal) Evidence of antenatal Doppler abnormalities Maternal gestational diabetes mellitus or pre-existing diabetes mellitus Maternal pre-eclampsia Signs of maternal chorioamnionitis Mode of delivery Transient Tachypnea of Newborn Pregnancy conceived by assisted reproductive technologies Maternal medication use Suspected or confirmed Trisomy 21 Gestational age at birth 35-36+6 gestation group Feeding type Mild neonatal encephalopathy Moderate and severe neonatal encephalopathy receiving therapeutic hypothermia

Trial contacts and locations

1

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Central trial contact

Eugene Dempsey

Data sourced from clinicaltrials.gov

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