Clinical Trials for Hypoplastic Left Heart Syndrome
There is currently 1 ongoing clinical trial exploring new approaches to support babies diagnosed before birth with hypoplastic left heart syndrome. This trial focuses on oxygen therapy given to pregnant mothers to potentially improve the development of the baby’s heart structures during pregnancy.
Clinical trial locations
Oxygen Therapy for Pregnant Women to Support Heart Development in Unborn Babies with Underdeveloped Left Heart Structures
This clinical trial is studying a new approach to support babies with underdeveloped left heart structures while they are still in the womb. The treatment being tested is called materno-fetal hyperoxygenation (MFHO), which involves giving the pregnant mother extra oxygen to breathe during the third trimester of pregnancy. The hope is that this extra oxygen will help the baby’s heart grow better before birth.
Who can participate:
- The mother must be at least 18 years old and in the last three months of pregnancy
- The mother must be a non-smoker
- The mother must have a normal uterine artery Doppler ultrasound on at least one side, which is a test that checks blood flow using sound waves
- The unborn baby must have at least one part of the left side of the heart that is not fully developed, confirmed by echocardiography
- The baby’s heart must still be functioning well enough to participate in the study
Who cannot participate:
- Pregnant women whose baby does not have a developmental disorder of the left side of the heart
- Women who are not in the third trimester of pregnancy
- Women who smoke
What the trial involves:
The main goal of this study is to see whether providing extra oxygen to the mother can help the baby’s heart structures grow more effectively. Participants will receive the oxygen treatment over a period of time during their pregnancy. The treatment uses a medicinal gas called LOX medicAL 100%, which is essentially pure oxygen that the mother breathes in.
Throughout the study, doctors will regularly monitor the baby’s heart growth using echocardiography, a safe imaging technique that uses sound waves to create pictures of the heart. Initial measurements are taken around the 32nd week of pregnancy, and final assessments are performed around the 35th week. The study will compare how much the baby’s heart structures have grown with the oxygen treatment compared to a placebo, to determine if the treatment makes a meaningful difference.
The oxygen therapy aims to increase the oxygen supply reaching the baby through the placenta, potentially stimulating the growth of the underdeveloped heart tissue. This approach is being tested to gather evidence on whether it can be an effective way to support babies with this condition before they are born.
Summary
Currently, there is one active clinical trial for hypoplastic left heart syndrome, taking place in Germany. This trial represents an innovative approach by focusing on prenatal intervention rather than waiting until after birth. The study explores whether oxygen therapy given to pregnant mothers during the third trimester can support the development of the baby’s underdeveloped left heart structures. This research is particularly significant as it aims to intervene early, potentially improving outcomes for babies diagnosed with this serious heart condition before birth.
