Early FETO for Severe Congenital Diaphragmatic Hernia

Congenital Diaphragmatic Hernia Clinical Trial

Official title:

"Early" Versus "Standard" Fetal Endoscopic Tracheal Occlusion for Severe Congenital Diaphragmatic Hernia - a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01731509
• Other study ID #: 8353/12
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 14, 2012
• Last updated: December 16, 2013
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2012
• Source: University of Sao Paulo General Hospital
• Contact: Rodrigo Ruano, MD PhD
• Phone: (5511)95739188
• Email: rodrigoruano[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Weeks to 28 Weeks

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic

Intervention

Other:
• Fetal endoscopic tracheal occlusion
FETO will be performed by placing a detachable balloon inside fetal trachea

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View Citation

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. — View Citation

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 Sep;34(3):304-10. doi: 10.1002/uog.6450. — View Citation

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. doi: 10.1097/AOG.0b013e31823d3aea. — View Citation

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. doi: 10.1159/000311944. Epub 2010 Apr 10. — View Citation

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. doi: 10.1002/uog.10142. Epub 2011 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	obstetrical complications (morbidity)	Preterm premature rupture of the membranes (<37 weeks); Extremely preterm premature rupture of the membranes (<32 weeks); Preterm delivery (birth <37 weeks of gestation); Extremely preterm delivery (birth <32 weeks); Placental abruption; Chorioamnionitis and maternal infection	pregnancy	Yes
Primary	Infant survival rate	Percentage of survivors at 6 months of life	6 months of life	No
Secondary	Postnatal severe pulmonary arterial hypertension (PAH)	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).	30 days of life	No
Secondary	Respiratory morbidity	Need for ventilatory support and/or oxygen dependency.	6 months of life	No