Fetal cranial MRI und neurodevelopement of children with congenital heart disease

Fetal cranial MRI und neurodevelopement of children with congenital heart disease - LEADER – Prenatal Imaging (LEADER = Long-term EArly DEvelopment Research)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00019889

Enrollment

Registered

2019-11-22

Start date

2020-02-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q24 F83

Interventions

Group 1: Study design: Prospective feasibility study In this study we want to investigate the correlation of pre- and postnatal changes in anatomy, morphology and perfusion of the developing brain i

after training by the study physicians, recruitment can also be carried out at other prenatal diagnostic specialist practices. The CHD is diagnosed by prenatal echocardiography. In addition, the fol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pregnant women of fetuses with CHD who, according to the literature, have an influence on brain development, e.g: Univentricular heart defects and heart defects with anomalies of the outflow tracts mean the following phenotypes: - Univentricular heart defects - Hypoplastic left heart syndrome/left heart complex - Tricuspid valve atresia - Atrioventricular septal defect - Heart defects with altered outflow tracts - High grade aortic valve stenosis or aortic cough stenosis - Aortic valve atresia - High grade pulmonary valve stenosis - Pulmonary valve atresia - Transposition of the large arteries One parent is German native speaker or both parents are German native speakers.

Exclusion criteria

Exclusion criteria: - Missing informed consent - Minor pregnant women

Design outcomes

Primary

Measure	Time frame
- Feasibility of the study protocol o Pre- and postnatal MRI examination according to protocol - Study acceptance o Ratio of pregnant women who have been asked to participate in a study and those who have consented to participate in a study - Study adherence o Ratio of included study participants vs. Number of drop-outs - Abnormalities in Head MRI Diagnostics and Fetal Ultrasound Diagnostics - Motor, cognitive and linguistic development measured on the Bayley III scale at the age of 12 months.	—

Measure

Time frame

- Feasibility of the study protocol o Pre- and postnatal MRI examination according to protocol - Study acceptance o Ratio of pregnant women who have been asked to participate in a study and those who have consented to participate in a study - Study adherence o Ratio of included study participants vs. Number of drop-outs - Abnormalities in Head MRI Diagnostics and Fetal Ultrasound Diagnostics - Motor, cognitive and linguistic development measured on the Bayley III scale at the age of 12 months.

—

Secondary

Measure	Time frame
Mortality (time of death derived from patient files). Child temperament as measured with the IBQ-R-SV (Infant Behavior Questionnaire-Revised, Short Version) at the age of 12 months.	—

Countries

Germany

Contacts

Public ContactAlexander Weichert

Pränatale Diagnostik und Therapie, Klinik für Geburtsmedizin, Charité - Campus Virchow Klinikum

alexander.weichert@charite.de+49-(0)30-450664188

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026