Clinical trial NCT04186039: Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations
Official title: Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD) of the Feta Lung in Congenital Diaphragmatic and Parietal Malformations
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Omphalocele
Gastroschisis
Keywords: Functional magnetic resonance imaging
Blood Oxygen Level Dependent effect
Congenital diaphragmatic hernia
Omphalocele
Gastroschisis
Fetal lung
Respiratory failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
First posted: 2019-12-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Major patient,
* patient with a simple pregnancy,
* patient between 28 and 33 weeks of amenorrhea,
* patient undergoing fetal MRI as part of their usual care, for fetal / placental indications : diaphragmatic hernia, omphalocele and laparoschisis,
* informed consent signed by the patient and the investigator,
* patient affiliated to a social security scheme (beneficiary or beneficiary).

Exclusion Criteria:

* Patient with one of the usual contraindications for MRI,
* claustrophobic patient,
* patient with an abdominal perimeter\> 125 cm,
* patient with multiple-birth pregnancy,
* patient with a pregnancy at the end of a long course of medical assisted procreation,
* patient with chronic respiratory disease.

Primary outcomes:
measure: Value of the Blood Oxygenation Level Dependent of the fetal lung
timeFrame: 30 months
measure: Postnatal respiratory evolution
timeFrame: 30 months
Secondary outcomes:
measure: Postnatal survival
timeFrame: 30 months
measure: Duration of oxygen dependence
timeFrame: 30 months
measure: Length of hospitalization
timeFrame: 30 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Naziha KHEN-DUNLOP, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent SALOMON, MD
role: STUDY_DIRECTOR
References: