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$1.9M grant will help protect newborns from necrotizing enterocolitis

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A University of Arizona College of Nursing-led research team will use a $1.9 million Department of Health and Human Services grant to lead a nationwide effort to keep babies safe from the deadly threat of necrotizing enterocolitis, known as NEC.

According to the NEC Society, more than 3,500 babies are diagnosed with necrotizing enterocolitis in the United States each year, and at least one baby dies from NEC every day. The gastrointestinal disease involves infection and inflammation in the gut and is one of the 10 leading causes of infant death. Black and Hispanic babies die of NEC at significantly higher rates than white babies.

The grant, which was awarded by the Agency for Healthcare Research and Quality, a division of Department of Health and Human Services, will fund the widespread distribution of an NEC prevention bundle, NEC-Zero, to help neonatal intensive care units prevent and improve timely recognition of NEC.

“NEC is a devastating disease that has long-term complications and lifetime impacts on babies,” said principal investigator Sheila Gephart, PhD, RN, professor and interim chair of the Advanced Nursing Practice and Science Division at the U of A College of Nursing.

“The NEC-Zero prevention bundle helps clinicians in any location deliver excellent care to any baby.”

NEC-Zero, which was developed by Gephart, uses evidence-based interventions that are essential to reduce the risk of contracting NEC. Tactics include giving the baby the mother’s milk, using a feeding protocol, limiting antibiotic and antacid exposure, and using strategies for timely recognition of the condition.

The telehealth approach to share it with neonatal intensive care units was co-created with Kimberly Shea, PhD, RN, a clinical professor at the College of Nursing, and program coordinator Christina Wyles, PhD, RN, who is a doctoral student and U of A fellowship award recipient.

“Our approach using telehealth is like a driver’s manual to help the real heroes – clinicians who are in NICUs helping babies and parents deal with this awful disease,” Gephart said.

“Neonatal clinicians to do their very best work for every baby every day to reduce the burden of NEC in fragile infants. Our team is eager to come alongside them to support them in doing so.”

Gephart’s team will train, mentor and support health care providers on NEC-Zero using telehealth-based educational material developed in collaboration with the Arizona Telemedicine Program and the University of New Mexico’s Project ECHO. The goal is to work with as many as 30 neonatal intensive care units across the country in the next few years.

“One thing that is really special about the project is that we don’t just connect with NICU teams, we also encourage them to connect with families as partners,” Gephart said, adding that printed materials are available to assist families with babies who contract NEC.

“The support of the Agency for Healthcare Research and Quality is instrumental in allowing Dr. Gephart and her team to improve the health of infants through the invaluable resources and training provided in the NEC-Zero toolkit,” said Brain Ahn, PhD, dean of the College of Nursing.

“Research projects such as this are instrumental to the College of Nursing’s goal of significantly improving health care outcomes through nurse-led research, outreach and educational programmes.”

Research

New test could cut need for invasive womb cancer checks

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A urine and vaginal fluid test could help rule out womb cancer in women with postmenopausal bleeding, potentially reducing invasive checks.

In a study of 1,864 women with postmenopausal bleeding, the test identified 80 of 99 womb cancers and correctly gave a negative result for 93 per cent of women without the disease.

Researchers said the test was not accurate enough to rule out cancer on its own, but could help fast-track women at the highest risk for urgent investigation while reducing immediate invasive testing for those at lower risk.

Professor Emma Davidson, of the University of Manchester and Manchester University NHS Foundation Trust, said: “Bleeding after the menopause is understandably alarming for women because it can be a sign of cancer, but the vast majority of those investigated will not have the disease.

“At the moment, many women face invasive, uncomfortable tests that can be stressful as well as costly for health services before cancer can be ruled out.

“Our study shows that a simple test using urine and vaginal samples could help identify the women most likely to have cancer while safely reassuring many others much earlier in the diagnostic pathway.

“If further studies confirm these findings in routine practice, this approach has the potential to transform care for thousands of women every year.”

Developed at the University of Manchester and Manchester University NHS Foundation Trust, the test examines cells collected from urine and vaginal fluid samples.

Postmenopausal bleeding currently triggers an urgent cancer referral, although only about 5 to 10 per cent of women who report it have an underlying cancer.

Current investigations include an internal ultrasound scan, a biopsy of the womb lining and hysteroscopy, in which a camera is passed into the womb.

Women taking part in the study attended seven hospitals in north-west England and provided urine and vaginal fluid samples before undergoing their routine tests.

Five per cent of participants, 99 of 1,864 women, were diagnosed with womb cancer through biopsy or surgery.

Cytologists assessed the samples without knowing the women’s diagnoses.

Researchers said the test could be used to triage women suspected of having womb cancer, with lower-risk patients monitored through repeat sampling or given a full assessment if symptoms continued.

They cautioned that the samples were assessed by highly trained specialist cytologists, so it is not yet known whether the same accuracy could be achieved in other settings.

The test has also not been studied in women without symptoms.

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Targeted nanotherapy shows endometriosis promise

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A targeted nanotherapy reduced endometriosis lesions and pain sensitivity after a single dose in mice, early research has found.

The experimental treatment uses a nanoparticle to deliver an existing drug to immune cells associated with endometriosis.

Researchers hope the approach could eventually lead to a treatment for people with the chronic condition, but it has not yet been tested in humans.

Kanako Hayashi, professor in Washington State University’s School of Molecular Biosciences in the College of Veterinary Medicine and a corresponding author of the research, said: “We found the disease-specific immune cell, and then we had a drug, but we couldn’t target the cell with the drug alone.

“So we used this nanocarrier that delivers the drug specifically to the disease site.”

The Washington State University team developed the therapy after previously identifying a distinct population of macrophages associated with endometriosis. Macrophages are white blood cells involved in immune defence.

They designed a nanocarrier, a specialised molecule used to transport drugs to the disease site, to target these cells without affecting surrounding cells and tissue.

The treatment uses niclosamide, a drug approved to treat intestinal tapeworms that is also being studied for other potential uses, including cancer treatment.

Previous research by the team found that niclosamide could reduce endometriosis lesions. However, the drug has low solubility, meaning large amounts are needed for it to work and limiting how long it can safely be taken.

The researchers engineered a nano-sized molecule called a dendrimer to bond with niclosamide and deliver it in a more soluble form.

In a mouse model, a single injection reduced the size and number of endometriosis lesions as well as sensitivity to pain.

Endometriosis affects roughly 190 million women worldwide and occurs when lesions similar to tissue inside the uterus grow outside it.

Symptoms can include chronic pain, severe cramps, pain during sex and infertility. Hormonal therapies can help manage symptoms but may affect fertility and bone density, while surgery can remove lesions but its effectiveness may be short-term.

Recent research has focused on immune system dysfunction in endometriosis, particularly problems involving macrophages.

The researchers are working with the WSU Office of Entrepreneurship and Innovation as they pursue patenting and commercialisation opportunities and seek support to test the technology in human trials.

Hayashi said: “Although we still need to clear multiple phases, this study is telling us the efficacy is strong, and this nanocarrier is stable, so far, for two weeks—and we think we can go longer.

“The idea is that if it’s stable for a month, you could go to the doctor once a month, get the shot, either IV or muscle injection, and then go home.”

 

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Menopause frequently missing from electronic health records – study

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Menopause is often absent from women’s electronic health records, a study of nearly 396,000 women has found.

Researchers found menopause appeared almost seven times more often in participant surveys than in electronic health records (EHRs).

The findings suggest important reproductive health information, including age at menopause, may often be missing from health records used for research.

Audrey Hendricks, associate professor of bioinformatics at CU Anschutz and the study’s principal investigator, said: “Ultimately, we cannot study what we do not measure. We cannot treat what we do not know.

“Menopause has enormous implications for women’s health, but if we don’t consistently capture when menopause occurs and other important reproductive health information, we limit our ability to understand how this transition affects disease risk and health outcomes.”

Researchers at the University of Colorado Anschutz analysed data from women taking part in the National Institutes of Health’s All of Us Research Program.

They compared menopause information reported by participants in surveys with menopause diagnoses recorded in their electronic health records.

Around 193,000 menopause observations were identified in survey data, compared with approximately 28,000 diagnoses in EHR data.

Menopause was documented in electronic health records for only about 7 per cent of women in the dataset.

Nearly all participants with a menopause diagnosis recorded in their EHR also reported menopause in survey data. However, substantially fewer women had menopause documented in their health records.

Other important information was also frequently unavailable, including age at menopause, which researchers may use when examining links between menopause and chronic disease risk.

Menopause is a physiological transition that can affect cardiometabolic health and many other aspects of women’s health.

Researchers said relatively little is known about how factors including the timing and type of menopause influence health outcomes across diverse populations.

Large-scale programmes such as All of Us combine participant surveys, electronic health records and genomic data, but menopause-related research depends on relevant reproductive health information being available.

Missing menopause information can make it harder to investigate how the transition relates to health and disease.

The findings may also help researchers using All of Us data define menopause-related study populations, design studies and estimate how many participants are needed.

Hendricks said: “We have an enormous opportunity to use large-scale datasets to understand women’s health across the menopause transition and to identify who may be at greater risk for disease.

“But we need to make sure that the information researchers need is actually being collected.

“We must do a better job of capturing women’s health information, including reproductive health and measures related to menopause.”

Researchers said more complete and consistent collection of menopause and reproductive health information could help future studies examine factors such as age at menopause and their relationship with disease risk and health outcomes.

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