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Oxygen Therapy for Pregnant Women to Support Heart Development in Unborn Babies with Underdeveloped Left Heart Structures

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition in unborn babies known as underdeveloped left heart structures. This condition affects the development of the left side of the heart in the fetus during pregnancy. The study will explore the use of a treatment called materno-fetal hyperoxygenation (MFHO), which involves providing the mother with extra oxygen to help improve the growth of the baby's heart structures.

The treatment being tested in this study is a medicinal gas called LOX medicAL 100%, which is essentially pure oxygen. The oxygen is given to the mother to breathe in, with the aim of helping the baby's heart develop better during the third trimester of pregnancy. The study will compare the effects of this oxygen treatment to those of a placebo to see if it makes a significant difference in the baby's heart development.

The purpose of the study is to gather evidence on whether providing extra oxygen to the mother can help the baby's heart grow more effectively. Participants in the study will receive the treatment over a period of time, and the growth of the baby's heart structures will be monitored through regular check-ups. The study aims to provide valuable insights into the potential benefits of oxygen therapy for unborn babies with this heart condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant is confirmed to meet the eligibility criteria, which include being at least 18 years old, in the third trimester of pregnancy, a non-smoker, and having a normal uterine artery Doppler ultrasound. The unborn baby must have a developmental disorder of the left side of the heart with sufficient cardiac function.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the fetal heart structures using echocardiography. This assessment helps establish baseline measurements for the study.

  3. Step 3

    Oxygen therapy administration

    The participant receives oxygen therapy through inhalation. The product used is LOX medicAL 100% (V/V), a medicinal gas in cryogenic form. The therapy aims to provide materno-fetal hyperoxygenation (MFHO) to support the growth of the underdeveloped fetal left ventricular structures.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the growth of the fetal heart structures. This includes repeated echocardiographic evaluations to measure changes in the heart structures under oxygen provocation.

  5. Step 5

    Final assessment

    A final assessment is performed around the 35th week of pregnancy to compare the growth of the fetal heart structures to the initial values recorded at the 32nd week. The primary endpoint is the median change in the sum of the Z-scores of the initially chosen echocardiographic fetal heart structures.

Who can join the trial?

6 criteria

  • The mother must be at least 18 years old.
  • The mother must be in the third trimester of pregnancy, which means she is in the last three months of her pregnancy.
  • The mother must be a non-smoker, meaning she does not smoke cigarettes.
  • The mother must have a Doppler ultrasound of the uterine artery that shows no problems on at least one side. A Doppler ultrasound is a test that uses sound waves to check blood flow.
  • The unborn baby must have a heart condition where at least one part of the left side of the heart is not fully developed. This is detected by a test called echocardiography, which uses sound waves to create images of the heart.
  • The unborn baby must have sufficient heart function, meaning the heart is working well enough to participate in the study.

Who cannot join the trial?

3 criteria

  • Pregnant women whose unborn baby does not have a developmental disorder of the left side of the heart cannot participate.
  • Individuals who are not in the third trimester of pregnancy are excluded.
  • Participants who are not part of the vulnerable population, which means those who may need special protection or care, are not eligible.
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Investigated drugs

Materno-fetal hyperoxygenation (MFHO) is a therapy used in this clinical trial. It involves providing extra oxygen to the mother during the third trimester of pregnancy. The goal is to help the growth of the baby's heart, specifically the left side, which may not be developing as it should. This therapy aims to improve the baby's heart development before birth.

What is already known about the treatment

Materno-fetal hyperoxygenation (MFHO) – This treatment involves administering increased oxygen levels to the mother during the third trimester of pregnancy, aiming to enhance the development of the fetal heart, specifically the left ventricular structures. Currently, MFHO is being studied in clinical trials to assess its effectiveness and safety for unborn babies with developmental disorders of the left side of the heart. The main therapeutic indication is to promote the growth of underdeveloped fetal heart structures. The mechanism of action involves increasing oxygen supply to the fetus, potentially stimulating cardiac tissue growth. This approach is classified under therapeutic interventions for fetal development.

Investigated diseases

Hypoplastic Left Heart Syndrome – This is a congenital heart defect where the left side of the heart is underdeveloped. It affects the normal blood flow through the heart, as the left side is responsible for pumping oxygen-rich blood to the rest of the body. In this condition, structures such as the left ventricle, mitral valve, aortic valve, and aorta may be smaller than normal or not fully developed. As a result, the heart must work harder to supply the body with blood, often relying on the right side to compensate. This can lead to increased pressure on the heart and lungs. The condition is typically identified before birth or shortly after.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512679-11-00Estimated enrolment64 patientsSponsorUniversitaetsklinikum Erlangen AöR

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