Maternal oxygen therapy during pregnancy for unborn babies with underdeveloped structures on the left side of the heart

Phase 1

Recruiting

• Conditions: unborn baby with developmental disorder of the left side of the heart; MedDRA version: 20.0Level: PTClassification code: 10021076Term: Hypoplastic left heart syndrome Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: CTIS2024-512679-11-00
• Lead Sponsor: niversitaetsklinikum Erlangen AöR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

>= 18 years of age (mother), third trimester of pregnancy (mother), non-smoker (mother), A. uterina doppler ultrasound at least one-sided without pathological findings (mother), cardiac disorder with at least one underdeveloped left ventricular structure detected by echocardiography (fetus), sufficient fetal cardiac function (fetus)

Exclusion Criteria

alcohol or drug abuse (mother), underlying disease or chromosomal abnormality which might influence the effect of MFHO (fetus), hemodynamic factors with influence on filling/emptying of the left heart which might affect MFHO efficacy (fetus), fetal cardiac failure (fetus), Hydrops fetalis (fetus), severe growth retardation (fetus), no flow in A. umbilicalis (fetus), severe extracardiac malformations (fetus), visit 2: inadequate response to O2 provocation during echocardiography (fetus), multiple pregnancy (mother), adipositas permagna (BMI>40) (mother), diabetes melllitus, insulin-dependent (mother), obstetrical issues (e.g. Cervix uteri <25mm, premature contractions, preeclampsia, eclampsia, HELLP Syndrome, …) (mother), fetus impossible to evaluate by echocardiography (mother), patholog. utero-placental resistance (mother), cardiac failure (NYHA III/IV or decompensated) (mother), severe COPD, hypercapnia (mother)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified