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

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ClinicalTrials.gov Identifier: NCT04186039
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Congenital Diaphragmatic Hernia Omphalocele Gastroschisis Diagnostic Test: Functional magnetic resonance imaging - Blood Oxygenation Level Dependent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD) of the Feta Lung in Congenital Diaphragmatic and Parietal Malformations
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: 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.
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.





Primary Outcome Measures :
  1. Value of the Blood Oxygenation Level Dependent of the fetal lung [ Time Frame: 30 months ]

    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).


  2. Postnatal respiratory evolution [ Time Frame: 30 months ]
    Duration of mechanical ventilation


Secondary Outcome Measures :
  1. Postnatal survival [ Time Frame: 30 months ]
    Survival rate at 30 days after birth

  2. Duration of oxygen dependence [ Time Frame: 30 months ]
    Total days of oxygen requiring

  3. Length of hospitalization [ Time Frame: 30 months ]
    Total days of the neonatal hospitalization before discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant patients
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186039


Contacts
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Contact: Naziha KHEN-DUNLOP, MD, PhD +33 1 44 49 41 98 naziha.khen-dunlop@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Hôpital Necker-Enfants Malades
Paris, France, 75015
Contact: Naziha KHEN-DUNLOP, MD, PhD    +33 1 44 49 41 98    naziha.khen-dunlop@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
Investigators
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Principal Investigator: Naziha KHEN-DUNLOP, MD, PhD Assistance Publique - Hôpitaux de Paris
Study Director: Laurent SALOMON, MD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04186039    
Other Study ID Numbers: APHP191058
2019-A02623-54 ( Other Identifier: ID-RCB Number )
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Functional magnetic resonance imaging
Blood Oxygen Level Dependent effect
Congenital diaphragmatic hernia
Omphalocele
Gastroschisis
Fetal lung
Respiratory failure
Additional relevant MeSH terms:
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Gastroschisis
Hernias, Diaphragmatic, Congenital
Hernia, Umbilical
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical
Congenital Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Hernia, Abdominal
Infant, Newborn, Diseases
Hernia, Ventral