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)
Primary Purpose
Congenital Diaphragmatic Hernia, Omphalocele, Gastroschisis
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional magnetic resonance imaging - Blood Oxygenation Level Dependent
Sponsored by
About this trial
This is an interventional diagnostic trial for Congenital Diaphragmatic Hernia focused on measuring Functional magnetic resonance imaging, Blood Oxygen Level Dependent effect, Congenital diaphragmatic hernia, Omphalocele, Gastroschisis, Fetal lung, Respiratory failure
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.
Sites / Locations
- Hôpital Necker-Enfants Malades
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Congenital diaphragmatic and parietal malformations
Arm Description
Patients with fetal magnetic resonance imaging as part of their usual medical care, for fetal / placental indications of diaphragmatic hernia, omphalocele or gastroschisis.
Outcomes
Primary Outcome Measures
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).
Postnatal respiratory evolution
Duration of mechanical ventilation
Secondary Outcome Measures
Postnatal survival
Survival rate at 30 days after birth
Duration of oxygen dependence
Total days of oxygen requiring
Length of hospitalization
Total days of the neonatal hospitalization before discharge
Full Information
NCT ID
NCT04186039
First Posted
December 2, 2019
Last Updated
November 4, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
1. Study Identification
Unique Protocol Identification Number
NCT04186039
Brief Title
Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations
Acronym
BOLD FETUS
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study manager's decision
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Filière des Maladies Rares Abdomino-THOraciques : FIMATHO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Diaphragmatic Hernia, Omphalocele, Gastroschisis
Keywords
Functional magnetic resonance imaging, Blood Oxygen Level Dependent effect, Congenital diaphragmatic hernia, Omphalocele, Gastroschisis, Fetal lung, Respiratory failure
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Congenital diaphragmatic and parietal malformations
Arm Type
Experimental
Arm Description
Patients with fetal magnetic resonance imaging as part of their usual medical care, for fetal / placental indications of diaphragmatic hernia, omphalocele or gastroschisis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional magnetic resonance imaging - Blood Oxygenation Level Dependent
Intervention Description
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 Measure Information:
Title
Value of the Blood Oxygenation Level Dependent of the fetal lung
Description
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
Title
Postnatal respiratory evolution
Description
Duration of mechanical ventilation
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Postnatal survival
Description
Survival rate at 30 days after birth
Time Frame
30 months
Title
Duration of oxygen dependence
Description
Total days of oxygen requiring
Time Frame
30 months
Title
Length of hospitalization
Description
Total days of the neonatal hospitalization before discharge
Time Frame
30 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant patients
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naziha KHEN-DUNLOP, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent SALOMON, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations
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