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Prediction of CDH Cardiac Dysfunction

Prenatal Echocardiography in Relation to Postnatal Heart Function in Children with Congenital Diaphragmatic Hernia - Prediction of CDH Cardiac Dysfunction

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58191
Enrollment
45
Registered
2025-10-07
Start date
2025-12-18
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Congenital diaphragmatic hernia Congenital hole in the diaphragm

Interventions

Not applicable.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Fetus diagnosed with left-sided CDHIsolated CDH: no associated structural or genetic abnormalities that are diagnosed before birthGestational age at delivery =35.0 weeksParental written informed consent for the PinC trial (MEC-2019-0414) and consent for re-use of data in future research

Exclusion criteria

Exclusion criteria: Right-sided or bilateral CDHMajor associated anomalies (structural and/or genetic)Maternal contraindications of PBCC: anterior placenta praevia, placental abruption.High urgency caesarean section, with intended interval to delivery less than 15 minCases that have been treated during pregnancy with experimental drug therapy aiming to decrease the occurrence of pulmonary hypertension (such as sildenafil)A twin pregnancy with one of the fetuses diagnosed with CDH and that infant is first born either vaginally or via caesarean sectionMultiple birth > 2 (triplets or higher order).Absence of all prenatal or all postnatal echocardiographic parametersNo consent given for re-use of data

Design outcomes

Primary

MeasureTime frame
RV diameter (prenatal)LV diameter (prenatal)Aortic valve diameter (prenatal)Pulmonary valve diameter (prenatal)Peak systolic velocity RV outflow tract (prenatal)Peak systolic velocity LV outflow tract (prenatal)Velocity time integral (prenatal)Tricuspid valve E/A  ratio (prenatal)Mitral Valve E/A ratio (prenatal)RV function (postnatal)RV S/D ratio (postnatal)TAPSE (postnatal)

Secondary

MeasureTime frame
ECMO in first 24 hoursSystemic blood pressurePulmonary artery acceleration time (PAAT)Right ventricular ejection time (RVET)Intraventricular septum configurationTricuspid regurgitationPeak velocity of tricuspid regurgitationTransductal shunting: direction Transductal shunting: peak flow velocityInteratrial shunting: direction

Countries

Netherlands

Contacts

Public ContactE.J.J. Oudshoorn

Erasmus MC, Universitair Medisch Centrum Rotterdam

e.horn-oudshoorn@erasmusmc.nl010-7040704

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026