Congenital Diaphragmatic HerniaPhase 2BRAFETONCT01302977
Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial
A Phase 2 study testing Fetal tracheal occlusion in people with Congenital Diaphragmatic Hernia and Congenital Abnormality, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Diaphragmatic Hernia, Congenital Abnormality
- What is being tested?
- Fetal tracheal occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient's refusal to participate in the study after allocation
- Preterm labor diagnosed before the procedure
- Preterm rupture of membranes before fetal intervention
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403010
Rodrigo Ruano, MD, PhD, 5511-30696445, rodrigoruano@usp.br
Nanci Valeis, 5511-3069-6442 r. 29, nanci.valeis@hcnet.usp.br
About this study
Official title: Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia
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.
Read the detailed description
Fetuses will be randomly allocated in two groups: 1. for fetal tracheal occlusion at 26-28 weeks (FETO group) or 2. Postnatal therapy only (Control)
Main outcome: Survival rate in both groups Second outcomes: Postnatal diagnosis of severe pulmonary arterial hypertension, percentage of newborns in each group that will have clinical conditions for neonatal surgical repair of the diaphragmatic defect, fetal lung responses (increase of fetal lung size), maternal and obstetrical complications (prematurity, preterm rupture of the membranes, maternal hemorrhage and infection).
- Being tested
- Fetal tracheal occlusion
- Keywords
- Congenital diaphragmatic hernia, Fetal anomalies
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal tracheal occlusionProcedure or surgery
Also called FETO, TO
Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fetal intervention | Experimental | Composed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks. Receives: Procedure: Fetal tracheal occlusion |
| Control | No intervention | Composed of fetuses that do not undergo fetal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Postnatal pulmonary arterial hypertension
Postnatal pulmonary arterial hypertension will be assessed up to 30 days of life according to the echocardiographic findings.
Measured: 30 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startMay 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Investigators
- Rodrigo Ruano, MD, PhD, Principal investigator, Faculdade de Medicina da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01302977
- Sponsor's protocol ID
- CAPPesq 1087/07
- Acronym
- BRAFETO
- Status last verified
- Feb 2011
- First submitted
- 21 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1159/000311944. Epub 2010 Apr 10.
PubMed 20389048Ruano 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.
PubMed 22170862
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracheal Occlusion Guided by Percutaneous Fetoscopy in Fetuses With Severe Isolated Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT01302977
- Acronym / sponsor ID
- BRAFETO / CAPPesq 1087/07
- Keywords
- Congenital diaphragmatic hernia, Fetal anomalies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil
- Study start
- May 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fetuses will be randomly allocated in two groups: 1. for fetal tracheal occlusion at 26-28 weeks (FETO group) or 2. Postnatal therapy only (Control)
Main outcome: Survival rate in both groups Second outcomes: Postnatal diagnosis of severe pulmonary arterial hypertension, percentage of newborns in each group that will have clinical conditions for neonatal surgical repair of the diaphragmatic defect, fetal lung responses (increase of fetal lung size), maternal and obstetrical complications (prematurity, preterm rupture of the membranes, maternal hemorrhage and infection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal intervention | Experimental | Procedure: Fetal tracheal occlusionComposed of fetuses that undergo to fetal tracheal occlusion at 26-28 weeks. |
| Control | No intervention | –Composed of fetuses that do not undergo fetal intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patient's refusal to participate in the study after allocation
- Preterm labor diagnosed before the procedure
- Preterm rupture of membranes before fetal intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal tracheal occlusionAlso: FETO, TOInsertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy | Procedure or surgery | Fetal intervention |
Primary outcome
Survival rate
Time frame: 1 year
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 secondary outcome
Postnatal pulmonary arterial hypertension
Time frame: 30 days of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
- Background: PubMed 20389048Ruano 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.
- Derived from this study: PubMed 22170862Ruano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, Brazil
Rodrigo Ruano, MD, PhD principal investigator
Faculdade de Medicina da Universidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fetal tracheal occlusion in people with Congenital Diaphragmatic Hernia and Congenital Abnormality, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01302977, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011; AzTrials last refreshed its copy on 6 Nov 2026.