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Risk Factors of Neonatal Respiratory Distress for Newborns With Prenatally Diagnosed Congenital Lung Malformations (MALFPULM)

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ClinicalTrials.gov Identifier: NCT02352207
Recruitment Status : Recruiting
First Posted : February 2, 2015
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

This research focuses on lung malformations detected in fetuses during prenatal ultrasound exams. Pathogenic mechanisms of these rare malformations are poorly understood. Improved knowledge is needed, to give families better information, and to better standardize treatment decisions The main goal is to better predict neonatal complications associated with these malformations, by identifying key predictive markers during the fetal period.

To achieve this objective, it is planned to include 400 pregnant women with prenatal diagnosis of pulmonary malformation in 45 health centers in France. This is the largest study on this topic at the international level.


Condition or disease Intervention/treatment
Foetus With Congenital Pulmonary Malformation Other: identification of a pulmonary malformation in the fetus

Detailed Description:

The main objective of the study is to develop a prognostic model for estimating the risk of neonatal respiratory distress in children with prenatally diagnosed congenital pulmonary malformation.

The study will be offered to all pregnant women referred to a Center for Prenatal Diagnosis (CPD), due to the identification of a congenital lung malformations in the fetus. This study does not induce any changes in clinical and therapeutic monitoring proposed by the team in charge of the mother. At inclusion, and at each prenatal evaluation, prenatal parameters are entered in an e-CRF. In an effort to minimize any potential intra- and interoperator variability in malformation measurements over time, this study includes a standardized and centralized evaluation of ultrasound and MRI (if available) acquisitions of volume measurements. When the place of delivery is determined, a contact is made before birth with the teams (maternity, neonatology, intensive care unit), so that neonatal data are also collected prospectively. A phone call to the family is planned for the end of the first postnatal month, to identify any respiratory event that would have occurred between returning home after childbirth and the first month.

The routine follow-up of these children is then ensured in accordance with current national recommendations, in conjunction with the reference centers for rare respiratory diseases in children (28 university hospitals, spread across all regions of France). A telephone survey every 6 months with the referring physician in this specialized center or, alternatively, with the family, will collect clinical outcome until the age of 2 years. If a surgical intervention is planned within this interval, consent to collect part of the surgical specimen for research purposes will be solicited. This tissue will be immediately frozen at -80 ° C, to allow laser microdissection and DNA extraction from epithelial cells lining the malformation (Inserm U955). Frozen tissue will be conserved at the biobank of Necker-Enfants Malades.


Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Identification of Predictors of Neonatal Respiratory Distress for Newborns With Prenatally Diagnosed Congenital Lung Malformations : A Population-based, Nationally Representative Study
Actual Study Start Date : March 17, 2015
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : April 30, 2021


Group/Cohort Intervention/treatment
identification of a pulmonary malformation in the fetus
pregnant women referred to a prenatal Center, because of the identification of a pulmonary malformation in the fetus
Other: identification of a pulmonary malformation in the fetus



Primary Outcome Measures :
  1. Respiratory distress [ Time Frame: At Birth of the child ]
    Respiratory distress at birth is defined by a breathing frequency > 60/min, or by the presence of chest retraction signs (Silverman score greater than or equal to 2). At least one of these signs must be persistent at 15' of life


Secondary Outcome Measures :
  1. Necessity of antenatal treatment [ Time Frame: At Birth of the child ]
    Thoracic drainage, amniotic drainage, corticosteroids

  2. Therapeutic abortion - fetal death [ Time Frame: At Birth of the child ]
  3. Severe respiratory distress [ Time Frame: At Birth of the child ]
    Severe respiratory distress at birth will be defined by the presence of at least one of the following parameters: persistent need at 15' of supplemental oxygen; Persistent need at 15' for a ventilatory support (non-invasive or invasive); neonatal death

  4. Identification of KRAS mutation [ Time Frame: At Birth of the child ]
    PCR analysis of known K-RAS mutations in codons 12 and 13


Biospecimen Retention:   Samples With DNA
A portion of tissue malformation


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women referred to a Center of Prenatal Diagnosis, because of the identification of a pulmonary malformation in the fetus
Criteria

Inclusion Criteria:

  • Prenatal identification of a congenital pulmonary malformation (hyperechoic and/or cystic pulmonary lesion)
  • consent of the mother for participation to the study

Exclusion Criteria:

- Absence of consent for participation


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): NCT02352207


Contacts
Contact: Christophe DELACOURT, MD, PhD +33 (0) 1 44 49 40 30 christophe.delacourt@nck.aphp.fr
Contact: Elodie HENRY, master +33 1 44 49 56 66 elodie.henry@aphp.fr

Locations
France
Hôpital Necker - Enfants Malades Recruiting
Paris, France, 75015
Contact: Christophe DELACOURT, MD, PhD    + 33 (0) 1 44 49 40 30    christophe.delacourt@nck.aphp.fr   
Contact: Laurence Lecomte, PhD    +33 1 71 19 64 94    laurence.lecomte@nck.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Laurent SALOMON, MD, PhD Hospital Necker - Enfants Malades

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02352207     History of Changes
Other Study ID Numbers: NI13005
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Neonatal respiratory distress
prenatal lung malformation
KRAS mutation
pregnant woman

Additional relevant MeSH terms:
Congenital Abnormalities
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases