Early FETO for Severe Congenital Diaphragmatic Hernia

NCT01731509 | Unknown Phase 2 DMC

• 1 other identifier: 8353/12
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Diaphragmatic Hernia

Keywords

congenital diaphragmatic hernia; fetoscopy; fetal endoscopic tracheal occlusion; pulmonary hypoplasia; fetal surgery; fetal lung

Outcome Measures

Primary Outcomes (1)

• Infant survival rate

  Percentage of survivors at 6 months of life

  6 months of life

Secondary Outcomes (2)

• Postnatal severe pulmonary arterial hypertension (PAH)

  30 days of life

• Respiratory morbidity

  6 months of life

Other Outcomes (1)

• obstetrical complications (morbidity)

  pregnancy

Study Arms (2)

Standard FETO

ACTIVE COMPARATOR

Group of fetus that undergo fetal endoscopic tracheal occlusion between 26 0/7 weeks and 28 6/7 weeks.

Other: Fetal endoscopic tracheal occlusion

Early FETO

EXPERIMENTAL

Group of fetus that undergo fetal endoscopic tracheal occlusion between 22 0/7 weeks and 24 6/7 weeks.

Other: Fetal endoscopic tracheal occlusion

Interventions

Fetal endoscopic tracheal occlusion OTHER

FETO will be performed by placing a detachable balloon inside fetal trachea

Also known as: FETO or fetal endoscopic traqueal occlusion

Early FETO; Standard FETO

Eligibility Criteria

• Age: 22 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Preterm premature rupture of the membranes before randomization
• Preterm labor before randomization

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (6)

• 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.

  PMID: 20389048 BACKGROUND

• 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.

  PMID: 22170862 BACKGROUND

• 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.

  PMID: 22183216 BACKGROUND

• 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. doi: 10.1056/NEJMoa035005.

  PMID: 14614166 BACKGROUND

• Jani JC, Nicolaides KH, Gratacos E, Valencia CM, Done 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.

  PMID: 19658113 BACKGROUND

• 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. doi: 10.1002/uog.1711.

  PMID: 15287047 BACKGROUND

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

Study Officials

• Rodrigo Ruano, MD PhD

  Faculdade de Medicina da Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo Ruano, MD PhD

CONTACT

(5511)95739188; rodrigoruano@usp.br

Eugenia MA Salustiano, RN

CONTACT

(5511)2661-6209; eugeniaassuncao@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 21, 2012
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 17, 2013

Record last verified: 2012-11

Locations

BR (1)