FETO Therapy for Congenital Diaphragmatic Hernia (FETO Trial)
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Children's Hospitals and Clinics of Minnesota
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This is a single site pilot trial to study the feasibility of Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy in the most severe group of fetuses with congenital diaphragmatic hernia (CDH) at Midwest Fetal Care Center, a collaboration between Allina Health and Children's Minnesota. This procedure aims to increase fetal lung volume before birth and improve survival after birth. This study will enroll 10 pregnant people and their baby who meet study criteria.
What data supports the idea that FETO Therapy for Congenital Diaphragmatic Hernia is an effective treatment?The available research shows that FETO therapy can improve the survival of infants with congenital diaphragmatic hernia. Several studies highlight its potential benefits, such as improved lung growth and development, which are crucial for infants with this condition. However, there are some concerns about possible complications like tracheomegaly, which is an enlargement of the trachea, and issues related to early birth. Despite these risks, the treatment is considered promising, especially for severe cases of the condition.268910
Is FETO therapy a promising treatment for congenital diaphragmatic hernia?Yes, FETO therapy is a promising treatment for congenital diaphragmatic hernia. It has been shown to improve lung growth and development, which can increase the chances of survival for infants with this condition.268910
What safety data exists for FETO therapy for Congenital Diaphragmatic Hernia?The provided research does not contain safety data for FETO therapy or its variants. The studies focus on fertility treatments and their associated risks, not on FETO therapy for Congenital Diaphragmatic Hernia.13457
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that you should not have current illicit drug use or over-the-counter drug abuse. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
This trial is for pregnant women over 18 with a severe case of left-sided congenital diaphragmatic hernia in their fetus (O/E LHR < 25%). They must be at 27-29 weeks gestation, have no other lethal fetal anomalies or major heart defects, and agree to stay within 15 minutes of the Midwest Fetal Care Center.Treatment Details
The study tests Fetoscopic Endoluminal Tracheal Occlusion (FETO) therapy on fetuses with severe CDH. It aims to increase lung volume before birth, potentially improving survival rates post-birth. The pilot will enroll ten participants to assess feasibility.
1Treatment groups
Experimental Treatment
Group I: FETO therapyExperimental Treatment1 Intervention
FETO therapy
FETO therapy is already approved in United States for the following indications:
🇺🇸 Approved in United States as FETO for:
- Severe congenital diaphragmatic hernia (CDH)
Find a clinic near you
Research locations nearbySelect from list below to view details:
Midwest Fetal Care CenterMinneapolis, MN
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Who is running the clinical trial?
Children's Hospitals and Clinics of MinnesotaLead Sponsor
Allina Health SystemCollaborator
References
Drugs in infertility and fetal safety. [2022]To evaluate the safety of drugs used in infertility treatment.
Tracheomegaly: a complication of fetal endoscopic tracheal occlusion in the treatment of congenital diaphragmatic hernia. [2021]Fetal endoscopic tracheal occlusion (FETO) is a promising treatment for severe congenital diaphragmatic hernia, a condition that carries significant morbidity and mortality. It is hypothesised that balloon occlusion of the fetal trachea leads to an improvement in lung growth and development. The major documented complications of FETO to date are related to preterm delivery.
Tubal factor infertility and perinatal risk after assisted reproductive technology. [2022]To assess trends of tubal factor infertility and to evaluate risk of miscarriage and delivery of preterm or low birth weight (LBW) neonates among women with tubal factor infertility using assisted reproductive technology (ART).
Adverse pregnancy and birth outcomes associated with underlying diagnosis with and without assisted reproductive technology treatment. [2022]To compare the risks for adverse pregnancy and birth outcomes by diagnoses with and without assisted reproductive technology (ART) treatment to non-ART pregnancies in fertile women.
Impact of fertility treatment on severe maternal morbidity. [2018]To determine if fertility treatment is associated with increased risk of severe maternal morbidity (SMM) compared with spontaneous pregnancies.
Fetoscopic Endoluminal Tracheal Occlusion in Fetuses with Severe Diaphragmatic Hernia: A Three-Year Single-Center Experience. [2018]To report on our experience in the prenatal treatment of severe congenital diaphragmatic hernia (CDH) by fetoscopic endoluminal tracheal occlusion (FETO).
[Impact of in vitro fertilization-embryo transfer on adverse pregnancy outcomes: A prospective cohort study]. [2019]To evaluate whether the in vitro fertilization-embryo transfer (IVF-ET) procedures could increases the risks of adverse pregnancy outcomes (APOs) in offspring. Methods: A hospital-based prospective cohort design was conducted, which contained a control group of singleton pregnancies with indicators of subfertility who were still conceived naturally after using simple medical treatment (e.g. minimal medical intervention or ovulation induction), and an exposure group consisted of singleton pregnancies who had a history of infertility and IVF-ET treatment. All factors different between two groups in the univariate analysis were included in the multivariable logistic regression to evaluate the independent effect of IVF-ET procedures themselves on APOs. Results: After controlling for confounding factors by using multivariate logistic regression analysis, our results showed that pregnancies after IVF-ET experienced a higher risk of preterm birth (OR=1.28, 95% CI 1.05 to 1.56), low birth weight (OR=1.69, 95% CI 1.27 to 2.31), perinatal mortality (OR=5.33, 95% CI 2.44 to 11.81), and congenital malformations (OR=1.83, 95% CI 1.12 to 2.94). Conclusion: The IVF-ET operational factors may increase the risk of APOs.
Feasibility and outcomes of fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: A Japanese experience. [2020]To present the feasibility, safety and outcomes of fetoscopic endoluminal tracheal occlusion (FETO) for the treatment of severe congenital diaphragmatic hernia (CDH).
Prevalence of symptomatic tracheal morbidities after fetoscopic endoluminal tracheal occlusion: a systematic review and meta-analysis. [2023]Fetoscopic endoluminal tracheal occlusion (FETO) has been shown to improve survival of infants with congenital diaphragmatic hernia (CDH). However, there are concerns that FETO may lead to tracheomegaly, tracheomalacia and related complications.
Fetal surgery using fetoscopic endoluminal tracheal occlusion for severe congenital diaphragmatic hernia: a single-center experience. [2023]To provide a comprehensive report of the experience gained in the prenatal treatment of congenital diaphragmatic hernia (CDH) using fetoscopic endoluminal tracheal occlusion (FETO) following its implementation at a newly established specialized fetal medicine center.