Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial Results

On June 8, 2021, the clinical trial results for the Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial, led by Jan Deprest, MD, PhD, Professor of Obstetrics and Gynaecology at the University Hospitals Leuven in Belgium, were published in the New England Journal of Medicine. The TOTAL Trial was an international, multicenter randomized controlled trial with two arms, the Severe Arm and the Moderate Arm, evaluating survival and morbidity in fetuses with congenital diaphragmatic hernia (CDH). The Severe Arm of the trial evaluated survival in fetuses with severe CDH detected prior to 30 weeks gestation, while the Moderate Arm evaluated survival and morbidity in fetuses with moderate CDH detected prior to 32 weeks gestation.

The findings of the Severe Arm of the trial indicate that prenatal intervention in fetuses with severe, isolated left-sided CDH resulted in a significant benefit over expectant care with respect to survival to discharge, and this benefit was sustained to 6 months of age. The findings of the Moderate Arm of the trial indicate that prenatal intervention in fetuses with moderate, left-sided CDH did not show a significant benefit over expectant care with respect to survival to discharge or the need for oxygen supplementation at 6 months. In both the Severe and Moderate Arms of the TOTAL Trial, prenatal intervention increased the risks of preterm, prelabor rupture of membranes and preterm birth. Click here to view more details about the TOTAL Trial.

In the ongoing effort to provide optimal care for patients, The Fetal Center, affiliated with Children’s Memorial Hermann Hospital (CMHH), McGovern Medical School at UTHealth, and UT Physicians, has been offering Fetoscopic Endoluminal Tracheal Occlusion (FETO) for the prenatal treatment of CDH through participation in both the Severe and Moderate Arms of the TOTAL Trial. The team of affiliated fetal surgeons, with extensive experience in fetoscopic intervention (> 800 fetoscopic cases), have worked with Professor Deprest in Belgium and in Houston to utilize the FETO technique at The Fetal Center. As a recognized, international leader in the prenatal diagnosis and management of CDH, our fetal center co-director, Anthony Johnson, DO, worked closely with Professor Deprest to lead the process of bringing the trial to the U.S., enrolling and managing these patients, and co-authoring the publication in the New England Journal of Medicine. As one of only 10 U.S. fetal centers granted FDA and institutional approval to offer FETO intervention and the only fetal center in the U.S. to participate in both arms of the TOTAL Trial, our Comprehensive Center for CDH Care and entire team are actively engaged and dedicated to improving outcomes for all patients with CDH – mild, moderate or severe.

With one of the most comprehensive CDH programs in the U.S., CMHH and UTHealth together approach every CDH patient as a survivor. With more than 30 years of experience, CMHH is a national referral center for CDH with an integrated team of affiliated specialists from UTHealth including maternal-fetal medicine specialists, neonatologists, pediatric surgeons, pediatric anesthesiologists and pediatric subspecialists. By integrating multidisciplinary expertise, UTHealth and CMHH provides quality care for families beginning at prenatal diagnosis through delivery, postnatal care, and long-term follow-up through childhood – with a smooth transition into adult specialty care. This treatment approach has translated into higher-than-expected risk-stratified survival, as well as one of the highest rates of surgical repair in the world.

CMHH and UTHealth together offer a complete approach to caring for CDH patients thanks to various integral components of our Comprehensive Center for CDH Care, including:

• Establishment of the first comprehensive extra-corporeal membrane oxygen (ECMO) program in Houston, and recognition as a Designated Center of Excellence by the Extracorporeal Life Support Organization (ELSO) since the inception of the award in 2006.
• The Fetal Center, which is an international leader in fetal diagnosis, fetal intervention and comprehensive fetal care for infants with congenital anomalies or genetic abnormalities.
• CMHH’s Level IV Neonatal Intensive Care Unit (NICU), providing the highest level of care to the most critically ill newborns. Our neonatologists have unique and focused expertise in the management of patients with CDH.
• Our high-risk, multidisciplinary center for CDH – one of only a few of its kind in the country – is specially designed for CDH patients and their families. Staffed by a multidisciplinary team of affiliated specialists, this center provides patients with a one-stop shop approach that allows families to see all pediatric specialists relevant to their case, in a single visit under one roof. In addition to offering convenience to patients and families, this approach allows our affiliated physicians to optimize patient care, collect data and understand the challenges faced by families of children with CDH in ways that were previously impossible. For our patients from a long distance, we can provide follow up with our state-of-the-art telemedicine program.
• A team of basic, translational, and clinical scientists focused on CDH seeking advances in knowledge and novel therapies. Our team leads international investigative collaborations and our institution has published over 40 original articles in CDH since 2019. In 2020, our team hosted the International Congenital Diaphragmatic Hernia Symposium, a CDH-dedicated educational conference with attendees representing 11 different countries. We are constantly striving to learn more in order to help patients who seek our expertise in Houston and around the world. We are currently conducting the only Phase I trial of stem cells for CDH in the world.
• Our laboratory research programs are looking at ways to improve the lung problems and blood vessel abnormalities seen in CDH, providing novel insights and potentially new therapeutic options.

The affiliated team at McGovern Medical School and Children’s Memorial Hermann is committed to providing specialized care for families affected by CDH. We strive to offer convenience for families and work with referring physicians to best serve patients. During these unprecedented times, we continue to take extra steps and implement additional safety practices in our patient care process to responsibly serve the community. We are available for in-person consultations and are utilizing telemedicine opportunities to connect with both patients and providers. This includes visits with our team virtually via a computer, or verbally over a phone call. We know that the anxiety of this diagnosis can be overwhelming for families, and we are happy to connect with little notice, any weekday.

We will continue offering the FETO intervention procedure to patients diagnosed with a CDH who qualify. As evidenced by our leadership with and involvement in innovative and collaborative trials like the TOTAL trial, along with our continued quest to advance the care of CDH patients and their families in an unparalleled, comprehensive program, we are confident that we can offer these patients exceptional expertise and uniquely advanced and tailored care. Additionally, we may be able to provide resources for patients who may need financial assistance if traveling to our Center to continue their care. Please contact our Center to inquire about these opportunities.

To read about how our first FETO patient is currently doing, click here.

To learn more about our comprehensive CDH program, view a list of the multidisciplinary team members, and view some more of our wonderful CDH patient stories, click here.

To refer a patient or speak to a clinician, call (832) 325-7288.