Proteomic Profiling for Congenital Diaphragmatic Hernia

NCT03179371 | Unknown

• 1 other identifier: API/2016/78
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Congenital diaphragmatic hernia (CDH) is a severe congenital malformation, related to a developmental defect of the diaphragm. The incidence of CDH is approximated at 1 in 3,000 live births. Although advances in surgery and neonatal intensive care have improved the prognosis, mortality remains high, around 30-50% related to severe lung hypoplasia and persistent pulmonary hypertension. Prenatal evaluation with observed/expected Lung over Head Ratio (o/e LHR), liver position and total lung volume measured by magnetic resonance, have been shown to correlate with neonatal mortality . However, the preponderant factor of persistent pulmonary hypertension remains difficult to predict prenatally. In patients with isolated diaphragmatic hernia (without associated malformations or karyotype abnormalities), prognosis is evaluated indirectly on pulmonary development from pulmonary volume measurements. Apart from the most caricatural cases with extremely good or very pejorative values, for a large proportion of fetuses with diaphragmatic dome hernia the prognosis remains uncertain. The aim of the proposal is to investigate whether the analysis of the proteom of the amniotic fluid of the fetuses with CDH could give information of a prognostic character. The objective of the study is to identify, from the proteomic profile of the amniotic fluid of mothers whose fetus has CDH, prognostic markers candidates for death at 2 months of the infant. The first step is to carry out an exploratory and non-interventional study on a small sample (n = 10) of the target population. This is a preliminary step before considering, if the results are encouraging, a large-scale study from a biological collection to determine candidate proteins (new biomarkers) which relative expression levels could be used as surrogate marker of pulmonary hypoplasia.

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (1)

• Neonatal death

  2 months of age

Secondary Outcomes (13)

• Prenatal death of the fetus

  9 months

• Neonatal death

  15 days

• Apgar score

  5 min after birth

• Age at surgery

  6 months of age

• Need for a diaphragmatic prosthesis

  6 months of age

Study Arms (1)

1

Mothers whose fetus has CDH

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Mothers whose fetus has CDH

You may qualify if:

• Pregnant patients for whom amniocentesis will be performed as part of the prenatal diagnosis of a diaphragmatic hernia.

You may not qualify if:

• Refusal of patients,
• Refusal of spouse regarding data of the future child,
• Multiple malformations,
• Twin pregnancy,
• Prenatal diagnosis of an unconfirmed diaphragmatic hernia,
• Miscarriage after amniocentesis.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• FEMTO-ST: collaborator

Study Sites (2)

CHU de Besançon

Besançon, 25000, France

ACTIVE NOT RECRUITING

CHU de Dijon

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

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

Central Study Contacts

Frédéric Auber, Professor

CONTACT

+ 33 3 81 21 82 21; fauber@chu-besancon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: June 7, 2017
• Study Start: May 18, 2017
• Primary Completion: July 1, 2019
• Study Completion: November 1, 2019
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)