Translating Innovating Imaging Technology to Clinical Use for Premature Infants

Summary

Necrotizing enterocolitis (NEC) is a serious disease that affects the intestines of premature babies. The condition inflames intestinal tissues, which causes the tissue to die. NEC typically occurs two to six weeks after birth. Symptoms of NEC can include abdominal pain and swelling, changes in heart rate and blood pressure, diarrhea with bloody stool, refusal to eat, and lack of weight gain. NEC can be hard to detect early and can be life-threatening. Anywhere between 20-40% of babies with NEC do not survive the disease.¹ Doctors face major challenges in diagnosing NEC early. The symptoms can be hard to spot, and current tests do not always give clear answers on diagnosis.² If doctors do not diagnose NEC early and start treatment, NEC can lead to severe illness or death.³ But if doctors misdiagnose a patient with NEC, the baby might go through unnecessary treatments, like stopping feeding or taking antibiotics, which can also cause harm. Because the number of at-risk babies is growing, there is an urgent need for better, faster, and more reliable ways to diagnose NEC early, so that babies can get the right care at the right time.

Drs. Victoria Weis (Wake Forest Institute for Regenerative Medicine), Jared Weis (Biomedical Engineering), Cherrie Welch (Neonatology), and Kristen Zeller (Pediatric Surgery) collaborated to develop diagnostic imaging technologies for NEC. After their initial study using photoacoustic imaging (PAI) in newborn rats,¹ researchers explored how well PAI could measure oxygen levels and movement in intestinal tissue in an experimental model of NEC. Their goal was to see if this non-invasive imaging method could help diagnose NEC. They believe PAI can detect changes in oxygen levels and intestinal movement, which are two key signs of NEC. This research is an important early step toward developing better tools to diagnose and monitor NEC in premature infants.⁴

Significance

This study shows that PAI can safely and effectively measure the two key signs of NEC in the intestines of both healthy and sick newborn rats. These measurements provide important insights into intestinal health. The pilot study is an early step toward future clinical trials that will test whether PAI can help diagnose NEC in premature babies. We designed and tested PAI with children in mind, rather than adults. This child-focused approach helps overcome the challenges of imaging smaller, more delicate bodies. The research team hopes their success will inspire the development of other tools made just for pediatric care.

Our work fills a gap in diagnosing and treating NEC. Without timely and accurate diagnostic tests for NEC, premature infants are much more likely to die from the disease. Using the PAI method to non-invasively look for key signs of PAI will help families get answers about the health of their newborns. With these answers, families can begin efficient and cost-effective care for NEC. Premature infants may have more specific health needs than full-term babies, so this method helps bridge a gap in care for premature infants.

Benefits

Demonstrated benefits are those that have been observed and are verifiable.

Potential benefits are those logically expected with moderate to high confidence.

Clinical & medical benefits

Showed that PAI can be used to diagnose NEC in premature infants. demonstrated.

Diagnostic procedures

Measure, diagnose, and treat NEC with applications of PAI. potential.

Biomedical technology

Community & public health benefits

Strengthen network of health care services for patients with NEC by using PAI to diagnose NEC in premature infants. potential.

Health care delivery

Improve the life expectancy of premature infants with NEC by using PAI to diagnose NEC, leading to faster treatment. potential.

Life expectancy & quality of life

Economic benefits

Reduce social and economic costs of illness by using PAI to diagnose NEC in premature infants, leading to faster treatment. potential.

Societal & financial cost of illness

This research has clinical, community, and economic implications. The framework for these implications was derived from the Translational Science Benefits Model created by the Institute of Clinical & Translational Sciences at Washington University in St. Louis.⁵

Clinical

PAI is a new tool that helps doctors check oxygen levels and movement in an infant’s intestines without surgery or other invasive procedures. These measures can make it easier to diagnose NEC and other intestinal diseases by providing clear and accurate information about key signs of illness. Because PAI was designed specifically for children, it works better for imaging small, delicate bodies than tools originally made for adults. This pilot study is an important first step toward future clinical trials that will test how safe and effective PAI is for diagnosing NEC. Additionally, the success of PAI as a pediatric-specific tool serves as a model for developing other innovative diagnostic methods tailored to children’s needs, fostering advancements in pediatric healthcare.

Community

Using PAI to diagnose NEC in premature infants could help build a stronger, more connected system of care for these vulnerable patients. By providing a safer, faster, and more accurate way to detect NEC, PAI can support earlier treatment decisions and reduce the need for invasive procedures. Using PAI in premature infants can reduce the long-term health complications often caused by delayed diagnosis. Early detection means shorter hospital stays and less time in intensive care, helping lower costs for families and the health systems. This technology may also help hospitals and clinics work together more effectively by offering a standardized tool that improves communication between care teams. As a result, families may experience more consistent care across different settings, helping reduce gaps in access and improving overall health outcomes for premature babies. By addressing the unique needs of the pediatric population, PAI can improve overall health outcomes for children, contributing to better long- term health and development. The researchers hope this technology will be widely used to detect NEC early and support faster treatment, which could help prevent serious illness or death in premature babies.

Economic

Using PAI to non-invasively detect early signs of NEC can help families get answers sooner and begin appropriate care more quickly. Faster diagnosis and treatment may reduce the need for emergency surgery, shorten hospital stays, and lower the use of intensive care resources. These improvements could lead to significant cost savings for families and healthcare systems, while also reducing emotional stress and long-term health complications. By improving early detection and care, PAI has the potential to ease the financial and societal burden of NEC and improve outcomes for premature infants.

Lessons Learned

The Wake Forest Clinical and Translational Science Institute provides innovative, efficient, and sustainable research infrastructure to accelerate Wake Forest University School of Medicine’s transformation into a leading health care system that is at the forefront of translational scientific discovery that impacts patient care. The CTSI Pilot Program at the Wake Forest University School of Medicine has been instrumental in facilitating the transition from preclinical to clinical research. Although the team has a promising approach, they recognize that it is only one part of the translational process. The CTSI Pilot Program empowered the team to use their approach in a clinical setting by supporting and connecting them to invaluable resources. In addition to the financial budget that supports research efforts, instrument costs, and participant expenses, the pilot program includes assistance from the research team’s CTSI study coordinator to navigate the IRB process and protect study participants using the new imaging technology. Additionally, the CTSI recruitment team supports the team in reaching pediatric study participants. The pilot program includes regular consultations with their CTSI Research Navigator and CTSI Pilot Program Faculty Advisor. This support will be instrumental for facilitating future research.