Early FETO for Severe Congenital Diaphragmatic Hernia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01731509
First received: November 14, 2012
Last updated: December 16, 2013
Last verified: November 2012
  Purpose

Congenital diaphragmatic hernia (CDH) is associated high mortality and morbidity, mainly in those cases with severe forms where there are extremely reduced lung volumes, liver herniation and decreased abnormal pulmonary vascularization. Fetal endoscopic tracheal occlusion performed between 26 and 30 weeks (standard FETO) has been shown to increase fetal pulmonary size and vascularity, and to improve infant survival in isolated severe CDH. Fetal pulmonary response followed FETO can be used to predict outcome and is dependent on the size of the fetal lung prior to the procedure.

We hypothesize that performing an earlier FETO, between 22-24 weeks, fetuses with severe form of CDH will have a better fetal pulmonary response and higher chance of surviving.


Condition Intervention Phase
Congenital Diaphragmatic Hernia
Other: Fetal endoscopic tracheal occlusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "Early" Versus "Standard" Fetal Endoscopic Tracheal Occlusion for Severe Congenital Diaphragmatic Hernia - a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Infant survival rate [ Time Frame: 6 months of life ] [ Designated as safety issue: No ]
    Percentage of survivors at 6 months of life


Secondary Outcome Measures:
  • Postnatal severe pulmonary arterial hypertension (PAH) [ Time Frame: 30 days of life ] [ Designated as safety issue: No ]
    Severe PAH will be considered when the neonate presents with profound cyanosis associated with echocardiographic continuous right-to-left shunting through a persistent 'ductus arteriosus' and a persistent difference in pre- to postductal saturation gradient >20%, despite the use of intake Nitric Oxide (iNO).

  • Respiratory morbidity [ Time Frame: 6 months of life ] [ Designated as safety issue: No ]
    Need for ventilatory support and/or oxygen dependency.


Other Outcome Measures:
  • obstetrical complications (morbidity) [ Time Frame: pregnancy ] [ Designated as safety issue: Yes ]
    1. Preterm premature rupture of the membranes (<37 weeks)
    2. Extremely preterm premature rupture of the membranes (<32 weeks)
    3. Preterm delivery (birth <37 weeks of gestation)
    4. Extremely preterm delivery (birth <32 weeks)
    5. Placental abruption
    6. Chorioamnionitis and maternal infection


Estimated Enrollment: 70
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard FETO
Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.
Other: Fetal endoscopic tracheal occlusion
FETO will be performed by placing a detachable balloon inside fetal trachea
Other Name: FETO or fetal endoscopic traqueal occlusion
Experimental: Early FETO
Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.
Other: Fetal endoscopic tracheal occlusion
FETO will be performed by placing a detachable balloon inside fetal trachea
Other Name: FETO or fetal endoscopic traqueal occlusion

Detailed Description:

We pretend to investigate if "early FETO" will improve the survival rate and the fetal pulmonary response, by conducting a randomized controlled trial comparing the results with those fetuses that undergo to "standard FETO" (between 26-28 weeks).

  Eligibility

Ages Eligible for Study:   22 Weeks to 28 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fetuses with isolated congenital diaphragmatic hernia (normal fetal karyotype and absence of any associated structural anomaly);
  • Gestational age established by last menstruation and/or first trimester ultrasonography;
  • Prenatal diagnosis of congenital diaphragmatic hernia before 24 weeks of gestation
  • Severe congenital diaphragmatic hernia (at 24 weeks, lung-to-head ratio <1.0 and at least 1/3 of the liver herniated into the fetal thorax)
  • written informed consent (by the patient)

Exclusion Criteria:

  • Preterm premature rupture of the membranes before randomization
  • Preterm labor before randomization
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731509

Contacts
Contact: Rodrigo Ruano, MD PhD (5511)95739188 rodrigoruano@usp.br
Contact: Eugenia MA Salustiano, RN (5511)2661-6209 eugeniaassuncao@hotmail.com

Locations
Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
University of Sao Paulo
Investigators
Principal Investigator: Rodrigo Ruano, MD PhD Faculdade de Medicina da Universidade de Sao Paulo
  More Information

Publications:

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01731509     History of Changes
Other Study ID Numbers: 8353/12
Study First Received: November 14, 2012
Last Updated: December 16, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
congenital diaphragmatic hernia
fetoscopy
fetal endoscopic tracheal occlusion
pulmonary hypoplasia
fetal surgery
fetal lung

Additional relevant MeSH terms:
Hernia
Hernia, Diaphragmatic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 20, 2014