2024-512679-11-00RecruitingPhase 3
Prospective, randomized, controlled, open, multicenter clinical trial on the efficacy and safety of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy to treat underdeveloped left ventricular structures of the fetus
Universitaetsklinikum Erlangen AöR7 sites in 1 country64 target enrollmentStarted: March 25, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 7
- Primary Endpoint
- median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation
Study Overview
Brief Summary
Evidence of efficacy of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy on growth of underdeveloped fetal left ventricular structures
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- In utero to 64 years (In utero, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation
median change of the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures under O2 provocation at the time point PW35d0 (+/- 2 days) compared to the initial values on PW32d0 (+/- 2 days) under O2 provocation
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Dr. Holm Schneider
Scientific
Universitaetsklinikum Erlangen AöR
Study Sites (7)
Loading locations...
Similar Trials
Recruiting
Phase 1
Maternal oxygen therapy during pregnancy for unborn babies with underdeveloped structures on the left side of the heartunborn baby with developmental disorder of the left side of the heartMedDRA version: 20.0Level: PTClassification code: 10021076Term: Hypoplastic left heart syndrome Class: 100000004850CTIS2024-512679-11-00niversitaetsklinikum Erlangen AöR64
Active, not recruiting
Not Applicable
Open, randomized, prospective, controlled, multicentre study to evaluate the efficacy and safety of multiple intraportal applications of liver cell suspension in patients with acute liver failure not eligible for orthotopic liver transplantatioAcute Liver FailureSubgroups of patients with indications falling under ICD classification codes:K70.4, K71, K72, K75, K76, K77MedDRA version: 9.1Level: LLTClassification code 10049844Term: Acute liver failureEUCTR2005-000837-39-DECytonet GmbH & Co. KG90
Active, not recruiting
Not Applicable
Open, randomized, prospective, controlled, multicentre study to evaluate the efficacy and safety of multiple intraportal applications of liver cell suspension in patients with acute liver failure not eligible for orthotopic liver transplantatioAcute Liver FailureSubgroups of patients with indications falling under ICD classification codes:K70.4, K71, K72, K75, K76, K77MedDRA version: 9.1Level: LLTClassification code 10049844Term: Acute liver failureEUCTR2005-000837-39-GBCytonet GmbH & Co. KG90
Active, not recruiting
Not Applicable
Open, randomized, prospective, controlled, multicentre study to evaluate the efficacy and safety of multiple intraportal applications of liver cell suspension in patients with acute liver failure not eligible for orthotopic liver transplantationEstudio abierto, aleatorizado, prospectivo controlado y multicéntrico para la evaluación de la efectividad y la seguridad de la administración reiterada de una suspensión de células hepáticas por la vena porta a pacientes con insuficiencia hepática aguda para los que no es factible efectuar un trasplante ortotópico de hígadoInsuficiencia hepática aguda (IHA) Subgrupos de pacientes con indicationes según ICD classification codes: K70.4, K71, K72, K75, K76, K77MedDRA version: 9.1Level: LLTClassification code 10049844Term: Acute liver failureEUCTR2005-000837-39-ESCytonet GmbH & Co. KG90
Active, not recruiting
Phase 1
Study to Evaluate the Safety and Efficacy of the MON4STRAT Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated, Adult Patients with Gram-Negative Lower Respiratory Tract Infection Including Nosocomial Pneumonia and Severe TracheobronchitisEUCTR2018-000450-21-ESFundación Investigación Biomédica Hospital Ramón y Cajal50