An interventional study of Functional magnetic resonance imaging - Blood Oxygenation Level Dependent in Congenital Diaphragmatic Hernia, Omphalocele and Gastroschisis, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
The objective is to evaluate the quality of the response to the Blood Oxygen Level Dependent effect in fetuses with diaphragmatic hernias and abdominal wall malformations and to correlate with postnatal respiratory outcome. Pulmonary involvement is a constant in diaphragmatic hernias, it is classic in omphaloceles and especially hepatomphaloceles, and exceptional in laparoschisis. As this is an original exploratory study, no preliminary data are available.
If a correlation is found, the Blood Oxygen Level Dependent effect of the fetal lung may be considered as an early functional marker of postnatal lung function. It can be used in addition to lung-to-head-ratio during prenatal counseling.
The final goal is to be able to detect early in the fetus pulmonary insufficiency to help prenatal counseling and perinatal care.
During the fetal period, there is in the lungs a permanent flow and pressure variations between the "inhaled" amniotic fluid and alveolar secretions, which are essential for pulmonary development. A disruption of this physiological mechanism can induce disorders of the respiratory function, which go from simple delay of maturation to hypoplasia. Respiratory function involves the thoracic muscles (diaphragmatic and intercostal) but also the abdominal muscles, that explains why breathing difficulties are found at birth in neonates with diaphragmatic hernia but also abdominal wall malformations.
This pulmonary involvement highly contributes to the morbidity observed at birth, for which strong prenatal predictive criteria are lacking.
Pulmonary volume measurement by the lung-to-head-ratio is widely used for diaphragmatic hernia has been extended to other congenital malformations, because no other available criteria. The lung-to-head-ratio is a parameter well correlated with survival but insufficiently with morbidity and sequelae.
New functional imaging techniques are in development. Among them, the Blood Oxygen Level Dependent uses hemoglobin as an endogenous contrast agent. It is based on the comparison of a basic status in ambient air with status after oxygenation. It gives a functional evaluation of the organs. But this technique has never been evaluated in the fetal lung yet.
The objective of the study is to evaluate the quality of the response to the Blood Oxygen Level Dependent effect in fetuses with diaphragmatic hernias and abdominal wall malformations and to correlate with postnatal respiratory outcome. It is an original exploratory study and no preliminary data are thus available.
If a correlation is found, the Blood Oxygen Level Dependent effect of the fetal lung may be considered as an early functional marker of postnatal lung function. It could then be used in addition to lung-to-head-ratio during prenatal counseling. The final goal is to be able to detect early in the fetus pulmonary insufficiency to help prenatal counseling and perinatal care.
86 studies on the registry are indexed under Hernias, Diaphragmatic, Congenital; 39 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Patients with fetal magnetic resonance imaging as part of their usual medical care, for fetal / placental indications of diaphragmatic hernia, omphalocele or gastroschisis.
Diagnostic Test: Functional magnetic resonance imaging - Blood Oxygenation Level Dependent
First Functional magnetic resonance imaging - Blood Oxygenation Level Dependent sequence under ambient air. Oxygenation of 5 minutes at a rate of 12 l / min. Second Functional magnetic resonance imaging - Blood Oxygenation Level Dependent sequence.
Value of the Blood Oxygenation Level Dependent of the fetal lung
Regions of interest (ROI) were manually identified on MRI images, with the largest possible homogenous 2D area. For the lungs, the ROIs were delineated at the maximal chest circumference, delineating the right lung, the left lung. Changes in haemoglobin concentration will be evaluated by the variation in transverse R2\* signal induced by oxygenation in the delimited ROI. The BOLD response will be calculated for each case as the difference between normoxic and hyperoxic period (∆R2\*) normalized by normoxic value: ∆R2\* = \[R2\*(norm)-R2\*(hyper)\] / R2\*(norm).
Time frame: 30 months
Postnatal respiratory evolution
Duration of mechanical ventilation
Time frame: 30 months
Postnatal survival
Survival rate at 30 days after birth
Time frame: 30 months
Duration of oxygen dependence
Total days of oxygen requiring
Time frame: 30 months
Length of hospitalization
Total days of the neonatal hospitalization before discharge
Time frame: 30 months
Plan to share: No
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This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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