NCT01302977

Brief Summary

The neonatal mortality rate in cases with severe isolated congenital diaphragmatic hernia is higher than 90% due to severe pulmonary hypoplasia. Many studies have suggested that fetal tracheal occlusion may increase lung volumes and therefore reducing the risk for severe pulmonary hypoplasia and by consequence the risk for neonatal death. The main objective of the present study is to evaluate if fetal tracheal occlusion improves survival rate in those cases that are followed in our hospital, by conducing a randomized trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 24, 2011

Status Verified

February 1, 2011

Enrollment Period

3.6 years

First QC Date

February 21, 2011

Last Update Submit

February 23, 2011

Conditions

Congenital Diaphragmatic HerniaCongenital Abnormality

Keywords

Congenital diaphragmatic herniaFetal anomalies

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    Noenatal survival rate which includes percentage of newborns that survive up to 30 days of life. Infant survival rate which includes percentage of newborns that survive up to one year of life. Outcome measurement will be assessed up to one year after birth.

    1 year

Secondary Outcomes (1)

  • Postnatal pulmonary arterial hypertension

    30 days of life

Study Arms (2)

Fetal intervention

EXPERIMENTAL

Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks.

Procedure: Fetal tracheal occlusion

Control

NO INTERVENTION

Composed of fetuses that do not undergo fetal intervention

Interventions

Fetal tracheal occlusionPROCEDURE

Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy

Also known as: FETO, TO
Fetal intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ultrasound diagnosis of congenital diaphragmatic hernia
  • fetuses at gestational age between 24 and 28 weeks
  • absence of chromosomal and/or other structural anomalies (isolated congenital diaphragmatic hernia)
  • severe congenital diaphragmatic hernia defined by lung-head ratio \< 1.0 and more than 1/3 of liver herniated into fetal thorax and observed/expected fetal total lung volume \< 0.35
  • patient's consent to participate in the present study

You may not qualify if:

  • Patient's refusal to participate in the study after allocation
  • Preterm labor diagnosed before the procedure
  • Preterm rupture of membranes before fetal intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403010, Brazil

RECRUITING

Related Publications (2)

  • 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: 20389048BACKGROUND

  • 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: 22170862DERIVED

MeSH Terms

Conditions

Hernias, Diaphragmatic, CongenitalCongenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, DiaphragmaticInternal HerniaHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Rodrigo Ruano, MD, PhD

    Faculdade de Medicina da Universidade de Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2011

First Posted

February 24, 2011

Study Start

May 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 24, 2011

Record last verified: 2011-02

Locations

BR(1)