Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 6/1/2018 |
| Start Date: | November 2011 |
| End Date: | January 2021 |
| Contact: | Jan A Deprest, MD |
| Email: | Jan.Deprest@uzleuven.be |
| Phone: | +3216344215 |
Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragma Hernia and Severe Pulmonary Hypoplasia.
This trial investigates whether prenatal intervention improves survival rate of fetuses with
isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to
expectant management during pregnancy, both followed by standardized postnatal care.
isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to
expectant management during pregnancy, both followed by standardized postnatal care.
Inclusion Criteria:
- Patients aged 18 years or more, who are able to consent
- Singleton pregnancy
- Anatomically and chromosomally normal fetus
- Left sided diaphragmatic hernia
- Gestation at randomization prior to 29 wks plus 5 d (so that occlusion is done at the
latest on 29 wks plus 6 d)
- Estimated to have severe pulmonary hypoplasia, defined prenatally as: O/E LHR <25 %,
irrespective of the liver position
- Acceptance of randomization and the consequences for the further management during
pregnancy and thereafter.
- The patients must undertake the responsibility for either remaining close to, or at
the FETO center, or being able to travel swiftly and within acceptable time interval
to the FETO center until the balloon is removed.
- Intended postnatal treatment center must subscribe to suggested guidelines for
"standardized postnatal treatment".
- Provide written consent to participate in this RCT
Exclusion Criteria:
- Maternal contraindication to fetoscopic surgery or severe medical condition in
pregnancy that make fetal intervention risk full
- Technical limitations precluding fetoscopic surgery, such as severe maternal obesity,
uterine fibroids or potentially others, not anticipated at the time of writing this
protocol.
- Preterm labour, cervix shortened (<15 mm at randomization) or uterine anomaly strongly
predisposing to preterm labour, placenta previa
- Patient age less than 18 years
- Psychosocial ineligibility, precluding consent
- Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided
outside the O/E LHR limits for the inclusion criteria
- Patient refusing randomization or to comply with return to FETO center during the time
period the airways are occluded or for elective removal of the balloon
We found this trial at
2
sites
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