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Congenital Diaphragmatic Herniapro-CDHNCT03179371

Proteomic Profiling for Congenital Diaphragmatic Hernia

An observational study of Congenital Diaphragmatic Hernia, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Congenital Diaphragmatic Hernia
How many people
10 participants
Where
2 sitesFrance
Study dates
18 May 2017to Nov 2019
Phase
Observational
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 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Mothers whose fetus has CDH

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Frédéric Auber, Professor contact

+ 33 3 81 21 82 21

fauber@chu-besancon.fr

France2 sites, 1 recruiting
  • CHU de Besançon

    Besançon, 25000

    Active, not recruiting
  • CHU de Dijon

    Dijon, 21000

    Thierry ROUSSEAU, MD, PhD, thierry.rousseau@chu-dijon.fr

    Recruiting

Other trials in France

About this study

Official title: Proteomic Analysis of Amniotic Fluid in the Case of Diaphragmatic Hernia: Search for Prognostic Expression Profiles

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.

Read the detailed description

Pregnant patients for whom amniocentesis will be performed as part of the prenatal management of CDH confirmed by fetal ultrasound will be approached fot inclusion in the study. The indication of amniocentesis will be indicated according to the usual standards of care. Briefly, the study will not involve any additional invasive procedure. In our study, amniocentesis will be indicated during the conventional management of these patients. The needs of our research will not lead to additional amniocenteses, but simply an increase in the volume of amniotic fluid collected. An additional volume of 5 ml will be sampled for volumes usually taken from 20 to 30 ml. This volume of sampling will have a very limited impact on maternal and fetal well-being. An analysis of the proteom of the amniotic fluid of the patients will be carried out. The relative amounts of proteins and peptides contained in the amniotic fluid will be analyzed to explore variations in proteomic profile that may reflect different clinical gravity in terms of further evolution. The usual management of the patients and their children will not be modified by the procedures related to the research.

The first step will consist in carrying out a depletion of the major proteins, in particular albumin. A protein assay will be carried out from the same amount of protein for each sample (standardization). This depletion step will be followed by a migration step on a gel of 1D electrophoresis. Its purpose is both to eliminate all the contaminants that can hinder mass spectrometry analysis, to separate the proteins according to their molecular weight in order to simplify the protein mixture and to have a visual control of the heterogeneity of the sample. A differential visual analysis after staining will allow to define the highly variable zones between the groups of patients and within the same sample. We will select the zone of interest in identical manner for each sample and for the whole of the gel track. The use of commercial electrophoresis gels of the same batch and the parallel analysis of several samples of different groups and the use of quality controls ensure reproducibility. The proteins contained in these bands / gel zones are then digested according to a standardized protocol under controlled conditions. The simultaneous treatment of the different biological samples makes it possible to considerably reduce the impact of the variability of this step in the final differential statistical analysis. At the end of this step the proteins are analyzed by an LC-ESI MS / MS approach. This LC-ESI MS / MS approach consists of separating the peptides on a chromatographic separation column which is coupled directly to the ESI-MS / M mass spectrometer. This analytical approach can allow the identification of more than 1000 proteins and 5000 peptides. This analysis is repeated 3 times per sample so that analytical variability can be taken into account in differential statistical studies. At the end of this protocol the raw data of each zone are pooled by sample and the differential statistical study can be carried out.

Medical subject headings
Hernias, Diaphragmatic, Congenital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03179371
Study groupRoleWhat they receive
1Mothers whose fetus has CDH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal death

    Measured: 2 months of age

Secondary outcomes (13)
  1. Prenatal death of the fetus

    Death during pregnancy

    Measured: 9 months

  2. Neonatal death

    Measured: 15 days

  3. Apgar score

    Measured: 5 min after birth

  4. Age at surgery

    Measured: 6 months of age

  5. Need for a diaphragmatic prosthesis

    Measured: 6 months of age

  6. Duration of ventilation (in days)

    Measured: 6 months of age

  7. Duration of the oxygen dependency (in days)

    Measured: 6 months of age

  8. Need of supplemental oxygen therapy

    Binary outcome (Yes/No)

    Measured: 28 days of age

  9. Occurrence of pulmonary hypertension

    Measured: 6 months of age

  10. Duration of parenteral nutrition (in days)

    Measured: 6 months of age

  11. Age at the beginning of enteral nutrition

    Measured: 6 months of age

  12. Age at the beginning of oral nutrition

    Measured: 6 months of age

  13. Duration of hospital stay (in days)

    Measured: 6 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study start18 May 2017
  3. Primary completionJul 2019 (estimated)
  4. Study completionNov 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03179371
Sponsor's protocol ID
API/2016/78
Acronym
pro-CDH
Status last verified
Jul 2018
First submitted
16 May 2017
Last updated
18 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Diaphragmatic Hernia, run by Centre Hospitalier Universitaire de Besancon at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Frédéric Auber, Professor (+ 33 3 81 21 82 21, fauber@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal death (time frame: 2 months of age). 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 18 Jul 2018.

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