Early FETO for Severe Congenital Diaphragmatic Hernia - Full Text View

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:

Genetics Home Reference related topics: congenital diaphragmatic hernia

MedlinePlus related topics: Endoscopy Hernia Hiatal Hernia High Blood Pressure

U.S. FDA Resources

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

Primary Outcome Measures:

Neonatal survival rate [ Time Frame: 30 days of life ] [ Designated as safety issue: Yes ]
Survivors at 30 days of life (after birth)
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:	January 2014
Estimated Study Completion Date:	December 2019
Estimated Primary Completion Date:	December 2019 (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

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:

Ruano R, Duarte SA, Pimenta EJ, Takashi E, da Silva MM, Tannuri U, Zugaib M. Comparison between Fetal Endoscopic Tracheal Occlusion Using a 1.0-mm Fetoscope and Prenatal Expectant Management in Severe Congenital Diaphragmatic Hernia. Fetal Diagn Ther. 2011;29(1):64-70. Epub 2010 Apr 10.

Ruano R, Yoshisaki CT, da Silva MM, Ceccon ME, Grasi MS, Tannuri U, Zugaib M. A randomized controlled trial of fetal endoscopic tracheal occlusion versus postnatal management of severe isolated congenital diaphragmatic hernia. Ultrasound Obstet Gynecol. 2012 Jan;39(1):20-7. Epub 2011 Dec 14.

Ruano R, da Silva MM, Campos JA, Papanna R, Moise K Jr, Tannuri U, Zugaib M. Fetal pulmonary response after fetoscopic tracheal occlusion for severe isolated congenital diaphragmatic hernia. Obstet Gynecol. 2012 Jan;119(1):93-101.

Harrison MR, Keller RL, Hawgood SB, Kitterman JA, Sandberg PL, Farmer DL, Lee H, Filly RA, Farrell JA, Albanese CT. A randomized trial of fetal endoscopic tracheal occlusion for severe fetal congenital diaphragmatic hernia. N Engl J Med. 2003 Nov 13;349(20):1916-24.

Jani JC, Nicolaides KH, Gratacós E, Valencia CM, Doné E, Martinez JM, Gucciardo L, Cruz R, Deprest JA. Severe diaphragmatic hernia treated by fetal endoscopic tracheal occlusion. Ultrasound Obstet Gynecol. 2009 Aug 5;34(3):304-310 [Epub ahead of print]

Deprest J, Gratacos E, Nicolaides KH; FETO Task Group. Fetoscopic tracheal occlusion (FETO) for severe congenital diaphragmatic hernia: evolution of a technique and preliminary results. Ultrasound Obstet Gynecol. 2004 Aug;24(2):121-6. Erratum in: Ultrasound Obstet Gynecol. 2004 Oct;24(5):594.

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:	November 14, 2012
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
Hernia, Hiatal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013