Congenital Diaphragmatic Hernia Chest ViewChildren who qualify and families who are interested have the opportunity to participate in groundbreaking research studies conducted by the physicians at McGovern Medical School at UTHealth. Affiliated with Children’s Memorial Hermann Hospital, the team of specialists – including fetal surgeons, pediatric surgeons and neonatologists – are dedicated to research and innovation for the prenatal and postnatal treatment congenital diaphragmantic hernia (CDH).

The affiliated team of CDH specialists offers patients and families the opportunity to participate in clinical trials, should they be interested. The team conducts many different types of trials and research, ranging from simple reviews of medical records and outcomes to complex therapy or intervention trials. Here are some examples of the research the team is involved in:

  • Basic science research on the blood vessels of the lungs.
  • Translational research introducing new therapies to patients.
  • Clinical research doing chart reviews and following patient results.
  • Multicenter collaborative research – our center coordinates the International CDH Study group, a consortium of centers who collaborate to evaluate outcomes and improve care.

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Completed Clinical Trials

The affiliated team has participated in the following CDH-related clinical trials, which have been completed and the results have been published:

  • TOTAL Trial* – Published in the New England Journal of Medicine

*The Fetal Center will continue offering the FETO intervention procedure to patients diagnosed with a severe CDH who qualify.

Research Trials

The team is conducting or participating in active, ongoing CDH trials:

CDH Umbilical Cord Research
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Umbilical Cord Blood Trial – offered to qualifying patients at time of delivery at Children’s Memorial Hermann Hospital

  • Goal:Determine if special cells (mononuclear cells) from a child’s own UCB are safe and improve outcome
  • Intervention: Autologous UCB given intravenously
  • Timing: Cells isolated at birth & administered in the 1st week of life
  • Follow-up: 2 years

Milrinone Trial – offered to qualifying patients in the Level IV Neonatal Intensive Care Unit (NICU) at Children’s Memorial Hermann Hospital

  • Goal: Determine if a drug helps improve blood oxygenation
  • Intervention: Administer a drug vs placebo intravenously
  • Timing: Within the first week of life
  • Follow-up: 1 year

iOS / Asthma Trial – offered to patients in the CDH Long-term Follow-up Clinic

  • Goal: Determine if older children have specific restrictive or obstructive airway issues
  • Intervention: None
  • Timing: 2 years old – 18 years old
  • Follow-up: as long as the child is in the clinic

The Fetal Center participates in ongoing research trials to advance medicine in the treatment of CDH and other conditions, with the goal of improving patient outcomes. The Fetal Center is one of only three U.S. centers to hold membership in all three key maternal-fetal research networks:

Pediatric surgeons in the division of General and Thoracic Pediatric Surgery at McGovern Medical School are internationally recognized for providing state-of-the-art neonatal critical care and minimally invasive surgical repair of CDH.

Congenital Diaphragmatic Hernia International Study Group and Registry

The care provided is based on data collected and new insights gained through the International Congenital Diaphragmatic Hernia Study Group and the CDH Registry, which reside at the hospital and medical school. In 1995, the CDH Study Group was founded by McGovern Medical School physicians, affiliated with Children’s Memorial Hermann Hospital, and the voluntary collaborative has gathered data on more than 13,000 babies with diaphragmatic hernia.

Overall worldwide survival of infants diagnosed with congenital diaphragmatic hernia (CDH) has increased from about 55% to above 70% in the last 30 years. Unfortunately, CDH remains a challenge for physicians, surgeons and scientists. Although the defect can be corrected with surgery, the arrest in prenatal development of the lungs results in unacceptably high rates of neonatal mortality and long-term complications for children born with CDH.

Thanks to more accurate prenatal diagnosis and the work of the international CDH Study Group – led by physicians affiliated with Children’s Memorial Hermann Hospital and McGovern Medical School – the global survival rate of infants born with CDH is steadily rising. Coordinated by Kevin P. Lally, MD, MS, and members from multiple specialties and centers, the CDH Study Group is a coalition of centers from around the world that track CDH patient outcomes in an international database – the CDH Registry. Based on risk-adjusted data, Children’s Memorial Hermann Hospital’s outcomes are in the top 10% or higher worldwide.

In the past 25 years since the CDH Study Group was founded, the voluntary collaborative has gathered data on more than 13,000 babies with CDH. The registry now represents centers in 16 countries. Information from this registry has been used in more than 50 CDH Study Group reports. These projects evaluate diagnostic and prognostic variables such as preductal oxygen saturation, defect size/anomaly association and pulmonary hypertension.

Investigators at Children’s Memorial Hermann Hospital are also engaged in promising research using extracellular vesicles, small membrane particles released from mesenchymal stem cells, to help manage pulmonary hypertension and reduce the mortality rate of CDH. While their research remains in the early stages, their aim is to translate innovative therapies to the clinical setting as quickly as possible.

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