Congenital Diaphragmatic HerniaBOLD FETUSNCT04186039
Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations
A study testing Functional magnetic resonance imaging - Blood Oxygenation Level Dependent in people with Congenital Diaphragmatic Hernia and Omphalocele, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Omphalocele, Gastroschisis
- What is being tested?
- Functional magnetic resonance imaging - Blood Oxygenation Level Dependent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- May 2020to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD) of the Feta Lung in Congenital Diaphragmatic and Parietal Malformations
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.
Read the 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
- Being tested
- Functional magnetic resonance imaging - Blood Oxygenation Level Dependent
- Keywords
- Functional magnetic resonance imaging, Blood Oxygen Level Dependent effect, Congenital diaphragmatic hernia, Omphalocele, Gastroschisis, Fetal lung, Respiratory failure
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Hernia, Umbilical, Gastroschisis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging - Blood Oxygenation Level DependentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Congenital diaphragmatic and parietal malformations | Experimental | Patients with fetal magnetic resonance imaging as part of their usual medical care, for fetal / placental indications of diaphragmatic hernia, omphalocele or gastroschisis. Receives: Diagnostic Test: Functional magnetic resonance imaging - Blood Oxygenation Level Dependent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 months
Postnatal respiratory evolution
Duration of mechanical ventilation
Measured: 30 months
Secondary outcomes (3)
Postnatal survival
Survival rate at 30 days after birth
Measured: 30 months
Duration of oxygen dependence
Total days of oxygen requiring
Measured: 30 months
Length of hospitalization
Total days of the neonatal hospitalization before discharge
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study startMay 2020 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: Study manager's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Filière des Maladies Rares Abdomino-THOraciques : FIMATHO, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Naziha KHEN-DUNLOP, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisLaurent SALOMON, MD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186039
- Sponsor's protocol ID
- APHP191058
- Other IDs
- 2019-A02623-54
- Acronym
- BOLD FETUS
- Status last verified
- Mar 2026
- First submitted
- 2 Dec 2019
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD) of the Feta Lung in Congenital Diaphragmatic and Parietal Malformations
- ClinicalTrials.gov ID
- NCT04186039
- Acronym / sponsor ID
- BOLD FETUS / APHP191058
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study manager's decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Filière des Maladies Rares Abdomino-THOraciques : FIMATHO, URC-CIC Paris Descartes Necker Cochin
- Study start
- May 2020 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital diaphragmatic and parietal malformations | Experimental | Diagnostic Test: Functional magnetic resonance imaging - Blood Oxygenation Level DependentPatients with fetal magnetic resonance imaging as part of their usual medical care, for fetal / placental indications of diaphragmatic hernia, omphalocele or gastroschisis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imaging - Blood Oxygenation Level DependentFirst 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. | Diagnostic test | Congenital diaphragmatic and parietal malformations |
Primary outcome
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).
Postnatal respiratory evolution
Time frame: 30 months
Duration of mechanical ventilation
3 secondary outcomes
Postnatal survival
Time frame: 30 months
Duration of oxygen dependence
Time frame: 30 months
Length of hospitalization
Time frame: 30 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Congenital Diaphragmatic Hernia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
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Fetoscopic Endoluminal Tracheal Occlusion in Severe Left Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia
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Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naziha KHEN-DUNLOP, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Laurent SALOMON, MD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging - Blood Oxygenation Level Dependent in people with Congenital Diaphragmatic Hernia and Omphalocele, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of the Blood Oxygenation Level Dependent of the fetal lung (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.