SYF93464794e0624aee94762a64510a7c54

RecruitingPhase 3

Maternal oxygen therapy during pregnancy for unborn babies w...

Universitaetsklinikum Erlangen AöR Source

Universitaetsklinikum Erlangen AöR

CTIS (EMA)

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Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

7

Brief Summary

Evidence of efficacy of materno-fetal hyperoxygenation (MFHO) during the third trimester of pregnancy on growth of underdeveloped fetal left ventricular structures

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Reported enrollment (type unavailable): Not reported
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 7 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 12, 2024
Actual (reported)

Conditions

unborn baby with developmental disorder of the left side of the heart

Outcome Measures

Primary Outcomes (1)

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

Interventions

LOX medicAL 100% (V/V) Gas zur medizinischen Anwendung, kälteverflüssigtType not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64)

You may qualify if:

>= 18 years of age (mother)
third trimester of pregnancy (mother)
non-smoker (mother)

Sponsors & Collaborators

Universitaetsklinikum Erlangen AöR
Type not reportedlead

Study Sites (7)

Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH

Regensburg, 93049, Germany

Angela Köninger+499413695201 angela.koeninger@barmherzige-regensburg.de

Universitaetsklinikum Mannheim GmbH

Mannheim, 68167, Germany

Thomas Kohl+491755971213 thomas.kohl@umm.de

Universitaetsklinikum Essen AöR

Essen, 45147, Germany

Antonella Iannaccone+492017233570

Central Study Contacts

Prof. Dr. Holm Schneider

+4991318533775 holm.schneider@uk-erlangen.de

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

March 12, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-512679-11-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 04:53:38 UTC

Documents

D4_HYPEROX_Subject_Card

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)

You may not qualify if:

alcohol or drug abuse (mother)
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)
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)
+2 more criteria

Contact the study team to confirm eligibility.

antonella.iannaccone@uk-essen.de

Universitaet Leipzig

Leipzig, 04103, Germany

Susanne Schrey-Petersen+493419723454 susanne.schrey@medizin.uni-leipzig.de

Universitaetsklinikum Erlangen AöR

Erlangen, 91054, Germany

Holm Schneider+4991318533775 holm.schneider@uk-erlangen.de

Klinikum Der Landeshauptstadt Stuttgart gKAöR

Stuttgart, 70174, Germany

Ulrich Karck+4971127863101 frauenklinik@klinikum-stuttgart.de

Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum

Bad Oeynhausen, 32545, Germany

Stephan Schubert+495731971381 sschubert@hdz-nrw.de

D1_HYPEROX_Protocol_redacted

E2_SmPC_LOX_medicAL

K1_Recruitment_IC_procedure_HYPEROX

K2_Recruitment_material_HYPEROX

L1_SIS_ICF_HYPEROX_redacted

L2_Diary_HYPEROX

L2_Information_IMP_HYPEROX_redacted

Locations

DE(7)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations