Assessing heart function in infants before and after birth
Comparison of Prenatal and Postnatal Cardiac Function Assessed by Echocardiography Between Foetuses/Neonates With a Structural Heart Disease, With an Fetal Growth Restriction (FGR) and Healthy Fetuses/Neonates
This study looks at how the hearts of babies before and after birth work, especially in those with heart problems or growth issues, to see if early changes can help doctors take better care of them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 201 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT05601375 on ClinicalTrials.gov |
What this trial studies
This observational study compares cardiac function in fetuses and neonates using advanced echocardiographic techniques, including pulsed wave Doppler, Tissue Doppler, and speckle tracking. It focuses on infants with structural heart disease, fetal growth restriction, and healthy controls to identify early changes in heart function that may influence clinical outcomes. By enhancing the understanding of myocardial contraction and relaxation, the study aims to improve early detection of cardiac dysfunction and inform preventive strategies for vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals with a fetus diagnosed with structural heart disease, fetal growth restriction, or a healthy fetus without major congenital abnormalities.
Not a fit: Patients with multiple pregnancies or known fetal genetic abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of cardiac issues in infants, enhancing their long-term cardiovascular health.
How similar studies have performed: While the approach of using advanced echocardiographic techniques is promising, it is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent * Sufficient command of the Dutch language * A pregnancy with a fetus with a structural heart disease, or * A pregnancy with a fetus with an FGR (defined as: weight and/or abdominal circumference p\<10, or deviating growth (weight and/or abdominal circumference) \> 20 percentiles, and Doppler abnormalities in either the umbilical artery, the uterine artery or the medial cerebral artery), or * A pregnancy with a healthy fetus (without any major fetal congenital abnormality) Exclusion Criteria: * Multiple pregnancy * A pregnancy with known fetal genetic abnormality * A pregnancy with other major fetal congenital abnormalities
Where this trial is running
Rotterdam
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.