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

NCT04186039 | Withdrawn

• 2 other identifiers: APHP1910582019-A02623-54
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

  30 months

• Postnatal respiratory evolution

  Duration of mechanical ventilation

  30 months

Secondary Outcomes (3)

• Postnatal survival

  30 months

• Duration of oxygen dependence

  30 months

• Length of hospitalization

  30 months

Study Arms (1)

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.

Diagnostic Test: Functional magnetic resonance imaging - Blood Oxygenation Level Dependent

Interventions

Functional magnetic resonance imaging - Blood Oxygenation Level Dependent 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.

Congenital diaphragmatic and parietal malformations

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Filière des Maladies Rares Abdomino-THOraciques : FIMATHO: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hernia, Umbilical; Gastroschisis; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Hernia, Ventral; Hernia, Abdominal; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Naziha KHEN-DUNLOP, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Laurent SALOMON, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: May 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)