Biomarker for Outcome Prediction in Neonates with Congenital Diaphragmatic Hernia

Biomarker for Outcome Prediction in Neonates with Congenital Diaphragmatic Hernia - BIOPTIC study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034329

Enrollment

350

Registered

2024-05-24

Start date

2014-04-30

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

Q79.0 Z38.0

Interventions

Group 1: After informing the parents or guardians, newborns with congenital diaphragmatic hernia (CDH) receive a blood sample of approx. 1 ml of EDTA blood at birth (umbilical cord blood, possibly als

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: diagnosis of congenital diaphragmatic hernia

Exclusion criteria

Exclusion criteria: Neonates received planned palliative care, CDH with concomitant congenital heart defect.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the composite endpoint of bronchopulmonary dysplasia or death. Bronchopulmonary dysplasia is defined as oxygen requirement beyond the 28th day of life. The combined endpoint includes newborns who died by 28 days of life.	—

Secondary

Measure	Time frame
Death Need for ECMO therapy according to the criteria of the CDH EuroConsortium Severity of pulmonary hypertension (PH) and cardiac dysfunction (PH severity is assessed based on the evaluation of: (1) peak velocity of tricuspid regurgitation (TR) jet; (2) interventricular septum position (normal, flattened or D-shaped); (3) ductal flow pattern, (4) tissue doppler imaging, (5) PAAT/PAET, (6) RV/LV ratio on apical 4-Chamber view. PH severity is classified in relationship to the systemic systolic blood pressure: less than 2/3 systemic pressure (mild PH), 2/3 systemic pressure to systemic pressure (moderate PH) and suprasystemic pressure (severe PH). Cardiac function is assessed in accordance with current American Society of Echocardiography Guidelines utilizing qualitative and quantitativemeasures in a stepwise approach. Function is classified as normal, RV dysfunction (indicated by, in order, global or regional cardiac hypokinesia, S’ wave -15%), or LV output <100ml/kg/min), or biventricular dysfunction (combination of LV and RV dysfunction). Length of mechanical ventilation and oxygen supplementation	—

Measure

Time frame

Death Need for ECMO therapy according to the criteria of the CDH EuroConsortium Severity of pulmonary hypertension (PH) and cardiac dysfunction (PH severity is assessed based on the evaluation of: (1) peak velocity of tricuspid regurgitation (TR) jet; (2) interventricular septum position (normal, flattened or D-shaped); (3) ductal flow pattern, (4) tissue doppler imaging, (5) PAAT/PAET, (6) RV/LV ratio on apical 4-Chamber view. PH severity is classified in relationship to the systemic systolic blood pressure: less than 2/3 systemic pressure (mild PH), 2/3 systemic pressure to systemic pressure (moderate PH) and suprasystemic pressure (severe PH). Cardiac function is assessed in accordance with current American Society of Echocardiography Guidelines utilizing qualitative and quantitativemeasures in a stepwise approach. Function is classified as normal, RV dysfunction (indicated by, in order, global or regional cardiac hypokinesia, S’ wave -15%), or LV output <100ml/kg/min), or biventricular dysfunction (combination of LV and RV dysfunction). Length of mechanical ventilation and oxygen supplementation

—

Countries

Germany

Contacts

Public ContactFlorian Kipfmueller

Universitätsklinikum Bonn, Klinik für Neonatologie und Pädiatrische Intensivmedizin

florian.kipfmueller@ukbonn.de+4922828733333

Outcome results

None listed

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