Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations

NCT ID: NCT04186039

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-31
• Study Completion Date: 2022-05-31

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.

Conditions

Congenital Diaphragmatic Hernia; Omphalocele; Gastroschisis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Congenital diaphragmatic and parietal malformations

Patients with fetal magnetic resonance imaging as part of their usual medical care, for fetal / placental indications of diaphragmatic hernia, omphalocele or gastroschisis.

Group Type: EXPERIMENTAL

Functional magnetic resonance imaging - Blood Oxygenation Level Dependent

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Filière des Maladies Rares Abdomino-THOraciques : FIMATHO

UNKNOWN

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naziha KHEN-DUNLOP, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Laurent SALOMON, MD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Necker-Enfants Malades

Paris, , France

Countries

France

Other Identifiers

2019-A02623-54

Identifier Type: OTHER

Identifier Source: secondary_id

APHP191058

Identifier Type: -

Identifier Source: org_study_id