Unlocking the Nexus: Vitamin D Deficiency and Nerve Health in Elderly Type 2 Diabetes Patients

In a groundbreaking investigation, researchers have delved into the profound interconnection between Vitamin D deficiency (VDD) and diabetic peripheral neuropathy (DPN) among elderly individuals grappling with type 2 diabetes mellitus (T2DM). This study, involving 257 elderly T2DM patients, presents compelling insights into the intricate relationship between Vitamin D levels and the development of peripheral nerve complications. It underscores the independent association between Vitamin D deficiency and an elevated risk of diabetic peripheral neuropathy in elderly individuals with type 2 diabetes mellitus.

The study results were published in the journal Diabetes Research and Clinical Practice.

Also Read: Triple combo of alpha-lipoic acid, epalrestat, and mecobalamin better for treating diabetic peripheral neuropathy than monotherapy : study

The research meticulously employed propensity score matching to ensure a balanced representation across age, sex, and diabetes duration among the participants. Vitamin D deficiency, marked by serum 25-hydroxyvitamin D [25(OH)D] levels below 20 ng/ml, emerged as a focal point for scrutiny. Assessments included electromyogram evaluations for large nerve fiber lesions and skin conductance measurements for small nerve fiber lesions.

Findings:

  • The outcomes painted a stark picture, revealing that individuals with diabetic peripheral neuropathy exhibited significantly lower serum 25(OH)D levels compared to their non-DPN counterparts (15.05 vs. 18.4 ng/ml, P = 0.018).
  • What emerged as a critical revelation was the identification of Vitamin D deficiency as an independent risk factor for DPN, with a robust odds ratio of 2.488 (P = 0.008) discerned through multivariate logistic regression analysis.
  • Spearman’s correlation further unearthed intricate associations between serum 25(OH)D levels and specific nerve parameters.
  • Negative correlations were noted with specific nerve latencies, while positive correlations manifested with specific nerve velocities and amplitudes.
  • Distinct characteristics were observed within the Vitamin D deficient group, showcasing prolonged median sensory nerve latencies and motor evoked potential latencies in contrast to their vitamin D-sufficient counterparts.
  • This group also exhibited a tangible association with the extension of median motor nerve latency (odds ratio = 1.362, P = 0.038).
Also Read: FDA Approves Spinal Cord Stimulation system for Painful Diabetic Peripheral Neuropathy patients

These findings underscore the independent association between Vitamin D deficiency and an escalated risk of diabetic peripheral neuropathy in the elderly T2DM population. The study suggests that Vitamin D deficiency may play a pivotal role in fostering the development of diabetic peripheral neuropathy, particularly by influencing large nerve fibers. As researchers unravel the intricate dance between Vitamin D and nerve health, these findings hold promise for targeted interventions and further research. Understanding the significance of maintaining optimal Vitamin D levels may prove instrumental in the comprehensive care and management of diabetic complications, offering a ray of hope for improved health outcomes in the aging population grappling with type 2 diabetes mellitus.

Further reading: Vitamin D deficiency increases the risk of diabetic peripheral neuropathy in elderly type 2 diabetes mellitus patients by predominantly increasing large-fiber lesions. DOI: https://doi.org/10.1016/j.diabres.2024.111585

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Keratinized mucosal width, supracrestal tissue height and dental implant diameter may influence peri-implant marginal bone loss

Keratinized mucosal width, supracrestal tissue height and implant diameter may influence peri-implant marginal bone loss suggests a new study published in the Clinical Implant Dentistry and Related Research.

There is evidence that the apico-coronal implant position and the mucosal phenotype can affect the extent of peri-implant bone loss. This clinical trial analyzes the bone remodeling and marginal bone loss that occur around conical-connection implants placed equicrestally and subcrestally, assessing the effect of the peri-implant soft-tissue phenotype. Fifty-one patients received 56 implants of distinct diameters (3.5 mm Ø n = 6; 4.3 mm Ø n = 41; 5 mm Ø n = 9) in the posterior part of the maxilla or mandible. The implants were placed equicrestally, 1 mm subcrestally and >1 mm subcrestally, depending on the initial supracrestal tissue height (STH). After 3 months of non-submerged healing, single metal-ceramic screw-retained implant-supported crowns were placed. Longitudinal measurements of STH, mucosal thickness and keratinized mucosa width (KMW) were made at the time of implant placement (T0), crown placement (T1), and after 3 (T2) and 6 months (T3) of prosthetic loading. At each of these points, a radiographic evaluation of bone remodeling and marginal bone loss was also performed. Results: STH was significantly greater for implants placed >1 mm subcrestally than for those placed 1 mm subcrestally. After 12 months of follow-up, a very significant (p < 0.001) loss of KMW was observed, in addition to a marginal bone loss of 0.08 ± 0.1, 0.15 ± 0.2, and 0.14 ± 0.2 mm in the groups placed equicrestally, 1 mm subcrestally and >1 mm subcrestally, respectively. After the multiple linear regression, marginal bone loss was found to depend primarily on KMW (β = −0.43), while also being affected by STH (β = 0.32) and implant diameter (β = −0.28). Marginal bone loss may be influenced by the position with respect to the bone crest, as well as the KMW, STH, and implant diameter. However, more well-controlled studies are needed to verify these above-mentioned findings with different implant designs and connections.

Reference:

Quispe-López N, Gómez-Polo C, Zubizarreta-Macho Á, Montero J. How do the dimensions of peri-implant mucosa affect marginal bone loss in equicrestal and subcrestal position of implants? A 1-year clinical trial. Clin Implant Dent Relat Res. 2024; 1-15. doi:10.1111/cid.13306

Keywords:

Keratinized mucosal width, supracrestal tissue height, implant diameter, peri-implant , marginal bone loss, Quispe-López N, Gómez-Polo C, Zubizarreta-Macho Á, Montero J

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Even Short-Term Exposure to Air Pollution Linked to Increased Mortality Rates: JAMA

While the association between air pollution and mortality is well-documented, few studies have utilized causal modeling approaches to comprehensively account for spatiotemporal confounders. A recent cross-sectional study aimed to estimate the relationship between short-term changes in fine particulate matter (PM2.5) and nitrogen dioxide (NO2) concentrations and daily all-cause mortality rates across four regions. This study was published in JAMA Network Open by Yiqun and colleagues.

Air pollution, particularly PM2.5 and NO2, poses significant health risks, including increased mortality rates. However, accurately estimating the impact of air pollution on mortality requires addressing confounding factors that vary across time and space. Causal modeling approaches offer a method to address these challenges and provide more precise estimates of the association between air pollution exposure and mortality.

The study analyzed air pollution and mortality data from Jiangsu, China; California; central-southern Italy; and Germany from 2015 to 2019. A total of 8,963,352 deaths were included in the analysis. Interactive fixed-effects models were used to control for both measured and unmeasured spatiotemporal confounders.

Key Findings:

  • A 10-μg/m3 increase in daily PM2.5 concentration was associated with an increase in daily all-cause deaths per 100,000 people ranging from 0.01 to 0.10 across the four regions.

  • Similarly, a 10-μg/m3 increase in NO2 concentration was associated with increases in mortality rates ranging from 0.03 to 0.10 across the regions.

  • Significant effect modifications by age, sex, and urbanity were observed in different regions, highlighting the complex interplay between air pollution exposure and demographic factors.

The study’s findings reinforce the link between short-term exposure to PM2.5 and NO2 and increased mortality rates across diverse geographical regions. Utilizing causal modeling approaches, the study provides robust estimates while accounting for unmeasured spatiotemporal confounders.

These findings underscore the importance of implementing policies to mitigate air pollution and protect public health. Further research is warranted to elucidate the mechanisms underlying the observed associations and inform targeted interventions to reduce air pollution-related mortality.

Reference:

Ma, Y., Nobile, F., Marb, A., Dubrow, R., Stafoggia, M., Breitner, S., Kinney, P. L., & Chen, K. Short-term exposure to fine particulate matter and nitrogen dioxide and mortality in 4 countries. JAMA Network Open,2024;7(3):e2354607. https://doi.org/10.1001/jamanetworkopen.2023.54607

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Study finds cognitive deficits even in fully recovered survivors of mild COVID

UK: A recent study published in the New England Journal of Medicine revealed similar small deficits in memory, thinking, or concentrating (“brain fog”) among COVID-19 patients recovering from short-term symptoms versus those with longer-term symptoms.

“Subjects with resolved persistent symptoms after COVID-19 had objectively measured cognitive function comparable to that in participants with shorter-duration symptoms,” the researchers wrote. Although short-duration COVID-19 was still linked with small cognitive deficits after recovery. The longer-term persistence of cognitive deficits and clinical implications remain uncertain.

Coronavirus disease 2019 (Covid-19) is a disease cause by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Cognitive symptoms after COVID-19 are well recognized, however, there is no clarity on whether objectively measurable cognitive deficits exist and how long they persist.

In this observational study, Adam Hampshire, Imperial College London, London, UK, and colleagues’ primary hypothesis was that there would be measurable cognitive deficits after COVID-19 that would scale with covariates of illness duration and severity. Secondarily, they speculated that objective impairments in memory and executive functions would be observable in persons with prolonged symptoms, especially poor memory or brain fog.

They addressed these hypotheses by analyzing cognitive-task performance data that were obtained in the Real-Time Assessment of Community Transmission (REACT) cohort in England.

800,000 adults were invited to a study in England to complete an online assessment of cognitive function. The researchers estimated a global cognitive score across eight tasks. Of the 141,583 participants who started the online cognitive assessment, 112,964 completed it.

Based on the study, the researchers reported the following findings:

  • In a multiple regression analysis, participants who had recovered from Covid-19 in whom symptoms had resolved in less than four weeks or at least 12 weeks had similar small deficits in global cognition as compared with those in the no-Covid-19 group, who had not been infected with SARS-CoV-2 or had unconfirmed infection (-0.23 SD and -0.24 SD, respectively); larger deficits as compared with the no-Covid-19 group were seen in participants with unresolved persistent symptoms (-0.42 SD).
  • Larger deficits were in participants who had SARS-CoV-2 infection during periods in which the original virus or the B.1.1.7 variant was predominant than in those infected with later variants (e.g., -0.17 SD for the B.1.1.7 variant vs. the B.1.1.529 variant) and in participants who had been hospitalized than in those who had not been hospitalized (e.g., intensive care unit admission, -0.35 SD).
  • The results of the analyses were similar to those of propensity-score-matching analyses.
  • In a comparison of the group that had unresolved persistent symptoms with the no-Covid-19 group, memory, reasoning, and executive function tasks were associated with the largest deficits (-0.33 to -0.20 SD); these tasks correlated weakly with recent symptoms, including poor memory and brain fog.
  • There were no adverse events.

Based on the results, the researchers found objectively measurable cognitive deficits that may persist for a year or more after COVID-19. They also found that participants with resolved persistent symptoms had small deficits in cognitive scores versus the no–COVID–19 group, which were similar to those in participants with shorter-duration illness.

“Early periods of the pandemic, longer illness duration, and hospitalization had the strongest associations with global cognitive deficits,” they wrote. “There is no clarity on the implications of the longer-term persistence of cognitive deficits and their clinical relevance and warrants ongoing surveillance.”

Reference:

Hampshire A, Azor A, Atchison C, Trender W, Hellyer PJ, Giunchiglia V, Husain M, Cooke GS, Cooper E, Lound A, Donnelly CA, Chadeau-Hyam M, Ward H, Elliott P. Cognition and Memory after Covid-19 in a Large Community Sample. N Engl J Med. 2024 Feb 29;390(9):806-818. doi: 10.1056/NEJMoa2311330. PMID: 38416429.

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People in urban areas with more green space have better mental health, suggests study

A new study from the Texas A&M University School of Public Health suggests that city dwellers who have more exposure to urban green spaces require fewer mental health services.

The study, published in the International Journal of Environmental Research and Public Health, was conducted by Jay Maddock, Ph.D., Regents Professor of environmental and occupational health at Texas A&M, and colleagues from the Center for Health and Nature, a collaboration between Texas A&M Health, Houston Methodist and Texan by Nature. Maddock also directs the center.

The researchers measured urban greenness with NatureScore, which uses numerous data sets related to factors such as air, noise and light pollution, parks and tree canopies to calculate the amount and quality of natural elements for any known address in the United States and several other countries. Scores range from 0-19 points for Nature Deficient to 80-100 for Nature Utopia.

For addresses, they used data on mental health visits aggregated at the ZIP code level from Texas Hospital Outpatient Public Use Data Files from 2014 to mid-2019. The data contained information about patient encounters, including a patient’s age, gender, race/ethnicity, educational attainment, employment status, poverty level, principal diagnosis and ZIP code, although no patients were identified.

“The association between exposure to nature and better mental health is well established in the United States and elsewhere, but most studies use just one or two measurements of this exposure,” Maddock said. “Our study was the first to use NatureScore, which provides more complex data, to study the correlation between urban nature exposure and mental health.”

A total of 61,391,400 adult outpatient encounters in Texas cities for depression, bipolar disorders, stress and anxiety were selected. The sample included data from 1,169 ZIP codes in urban Texas, with a median NatureScore of 85.8. About half of the sample had high NatureScores (80+), and about 22 percent had NatureScores below 40.

Of these encounters, 63 percent were women, 30 percent were 65 years old or older, 54 percent were non-Hispanic white, and 15 percent were Hispanic. At the ZIP code level, 27 percent of the total population had a bachelor’s degree, 58 percent were employed, 14 percent lived under poverty, and 17 percent lacked health insurance coverage. The percentage of those 65 years old and older, white, Hispanic and employed were higher in areas with a higher NatureScore. In addition, the ZIP codes with a higher NatureScore had lower percentages of people who were Black, living in poverty or without insurance.

The trend for various mental health encounters decreased as the NatureScore of a neighborhood increased, and the rates of mental health encounters were about 50 percent lower in neighborhoods with NatureScores over 60. Those who lived in neighborhoods with the two highest NatureScore categories-Nature Rich and Utopia-had significantly lower rates of mental health encounters compared to neighborhoods with the lowest NatureScore category.

“We found that a NatureScore above 40-considered Nature Adequate-seems to be the threshold for good mental health,” Maddock said. “People in these neighborhoods have a 51 percent lower likelihood of developing depression and a 63 percent lower likelihood for developing bipolar disorders.”

The study’s lead author, Omar M. Makram, noted that these findings could have important implications for urban planning.

“Increasing green space in cities could promote well-being and mental health, which is critically important given that more than 22 percent of the adult population in the United States with a mental health disorder,” he said.

Reference:

Makram OM, Pan A, Maddock JE, Kash BA. Nature and Mental Health in Urban Texas: A NatureScore-Based Study. International Journal of Environmental Research and Public Health. 2024; 21(2):168. https://doi.org/10.3390/ijerph21020168.

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Transoesophageal Echocardiography Proves Vital for assessing residual lesions during Pediatric Heart Surgery

A recent study published in the recent edition of Archives of Cardiovascular Diseases unveiled the pivotal role of pediatric transoesophageal echocardiography probes in the perioperative evaluation of congenital heart disease surgeries. This innovative approach promises the enhanced safety and precision of echocardiography in pediatric cardiac interventions.

This study was conducted over the span of four years at a leading tertiary center and evaluated the efficacy of perioperative transoesophageal echocardiography in assessing residual lesions post-heart surgery in pediatric patients. The retrospective analysis encompassed 323 procedures after involving 310 young patients, with the median age of 13.8 months. The residual lesions were classified as mild, moderate or severe and were meticulously scrutinized using transoesophageal echocardiography. Also, 6.5% of cases revealed severe residual lesions necessitating immediate reintervention.

The critical findings highlight the severe right ventricular outflow tract obstruction that emerged as a predominant concern which prompts swift corrective measures in 12 cases. Additionally, instances of severe aortic regurgitation, superior vena cava stenosis and moderate residual ventricular septal defects underlined the significance of real-time perioperative evaluation.

Also, three neonates encountered ventilation difficulties due to the transoesophageal echocardiography probe, albeit without any lasting consequences. The findings of this study concludes that perioperative transoesophageal echocardiography represents a safe and invaluable adjunct in pediatric congenital heart disease surgeries. Its ability to promptly identify and address severe residual lesions has the potential to revolutionize the landscape of pediatric cardiac care by offering hope to young patients and their families. The integration of innovative technologies like transoesophageal echocardiography promises to elevate the standards of care and transform the outlook for pediatric cardiac patients worldwide. 

Reference:

Pyra, P., Hadeed, K., Guitarte Vidaurre, A., Vincent, R., Dulac, Y., Chausseray, G., Calvaruso, D. F., Acar, P., & Karsenty, C. (2024). Usefulness of perioperative transoesophageal echocardiography during paediatric cardiac surgery. In Archives of Cardiovascular Diseases. Elsevier BV. https://doi.org/10.1016/j.acvd.2023.12.006

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Endoscopic gallbladder stenting prevents recurrent cholecystitis among patients with deferred cholecystectomy: Study

According to a study published in Gastroenterology, Endoscopic transpapillary gallbladder stenting or ETGS can help prevent recurrent cholecystitis in acute cholecystitis patients with Common bile duct stones who have deferred cholecystectomy for three months. Most recurrences occurred within three months in those who did not receive ETGS.

Endoscopic transpapillary gallbladder stenting (ETGS) has been proposed as one of the adjunctive treatments, apart from antibiotics, before surgery in patients with acute cholecystitis whose cholecystectomy could not be performed or deferred.

ETGS has emerged as an alternative treatment for acute cholecystitis patients who cannot undergo or delay cholecystectomy. Although ETGS has been suggested as an adjunct to antibiotics, there is currently no data comparing its outcomes in patients who receive it versus those who do not. The objective of the present study is to evaluate the recurrent cholecystitis rates at 3 and 6 months in these two groups.

Between 2020-2023, eligible acute-calculous-cholecystitis patients (n=120) with a high probability of CBD stone, who were surgical candidates but could not have an early cholecystectomy during COVID-19 surgical lockdown, were randomized into groups A and B with 60 patients each. Group A received ETGS, and B did not. A definitive cholecystectomy was performed at three months or later in both groups.
Group A’s technical and clinical success rates were 90% and 100%, respectively. Based on intention-to-treat analysis, group A had a lower recurrence rate than group B at three months. At 3-6 months, group A showed a non-significantly lower rate of recurrent cholecystitis than group B.
Endoscopic transpapillary gallbladder stenting (ETGS) can effectively prevent recurrent cholecystitis in acute cholecystitis patients with CBD stones who have deferred cholecystectomy for three months. It is worth noting that most recurrences occur within the first three months after the procedure in patients who do not receive ETGS.
Reference:
Ridtitid, W., Karuehardsuwan, J., Faknak, N., Piyachaturawat, P., Vongwattanakit, P., Kulpatcharapong, S., Angsuwatcharakon, P., Mekaroonkamol, P., Kongkam, P., & Rerknimitr, R. (2024). Endoscopic gallbladder stenting to prevent recurrent cholecystitis in deferred cholecystectomy: a randomized trial. Gastroenterology. https://doi.org/10.1053/j.gastro.2024.02.007

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More schooling linked to slowed aging and increased longevity: JAMA

Participants in the Framingham Heart Study who achieved higher levels of education tended to age more slowly and went on to live longer lives as compared to those who did not achieve upward educational mobility, according to a new study at Columbia University Mailman School of Public Health and The Robert N. Butler Columbia Aging Center. Upward educational mobility was significantly associated with a slower pace of aging and lower risk of death. The results are published online in JAMA Network Open.

The Framingham Heart Study is an ongoing observational study first initiated in 1948 that currently spans three generations.

The Columbia analysis is the first to connect educational mobility with pace of biological aging and mortality.

“We’ve known for a long time that people who have higher levels of education tend to live longer lives. But there are a bunch of challenges in figuring out how that happens and, critically, whether interventions to promote educational attainment will contribute to healthy longevity,” said Daniel Belsky, PhD, associate professor of Epidemiology at Columbia Mailman School and the Aging Center and senior author of the paper.

To measure pace of aging, the researchers applied an algorithm known as the DunedinPACE epigenetic clock to genomic data collected by the Framingham Heart Study. The latest findings showed that, according to the yardstick of the DunedinPACE epigenetic clock, two years of additional schooling translated to a two- to three percent slower pace of aging. This slowing in the pace of aging corresponds to a roughly 10 percent reduction in risk of mortality in the Framingham Heart Study, according to previous research by Belsky on the association of DunedinPACE with risk of death.

DunedinPACE was developed by the Columbia researchers and colleagues and reported in January 2022. Based on an analysis of chemical tags on the DNA contained in white blood cells, or DNA methylation marks, DunedinPACE is named after the Dunedin Study birth cohort used to develop it. DunedinPACE (stands for Pace of Aging Computed from the Epigenome), is measured from a blood test and functions like a speedometer for the aging process, measuring how fast or slow a person’s body is changing as they grow older.

Biological aging refers to the accumulation of molecular changes that progressively undermine the integrity and resilience capacity of our cells, tissues and organs as we grow older.

The Columbia researchers used data from 14,106 Framingham Heart Study spanning three generations to link children’s educational attainment data with that of their parents. They then used data from a subset of participants who provided blood samples during data collection to calculate the pace of biological aging using the DunedinPACE epigenetic clock. In primary analysis, the researchers tested associations between educational mobility, aging, and mortality in a subset of 3,101 participants for whom educational mobility and pace of aging measures could be calculated.

For 2,437 participants with a sibling, the researchers also tested whether differences in educational attainment between siblings was associated with a difference in the pace of aging.

“A key confound in studies like these is that people with different levels of education tend to come from families with different educational backgrounds and different levels of other resources,” explained Gloria Graf, a PhD candidate in the Department of Epidemiology supervised by Belsky, and first author of the study. “To address these confounds, we focused on educational mobility, how much more (or less) education a person completed relative to their parents, and sibling differences in educational attainment – how much more (or less) education a person completed relative to their siblings. These study designs control for differences between families and allow us to isolate the effects of education.”

By combining these study designs with the new DunedinPACE epigenetic clock, the researchers were able to test how education affects the pace of aging. Then, by linking the education and pace of aging data with longitudinal records of how long participants lived, the team was able to determine if a slower pace of aging accounted for increased longevity in people with more education.

“Our findings support the hypothesis that interventions to promote educational attainment will slow the pace of biological aging and promote longevity,” noted Graf. “Ultimately, experimental evidence is needed to confirm our findings,” added Belsky. “Epigenetic clocks like DunedinPace have potential to enhance such experimental studies by providing an outcome that can reflect impacts of education on healthy aging well before the onset of disease and disability in later life.”

“We found that upward educational mobility was associated both with a slower pace of aging and decreased risk of death,” said Graf. “In fact, up to half of the educational gradient in mortality we observed was explained by healthier aging trajectories among better-educated participants.” This pattern of association was similar across generations and held within family sibling comparisons: siblings with higher educational mobility tended to have a slower pace of aging as compared with their less educated siblings.

Reference:

Graf GHJ, Aiello AE, Caspi A, et al. Educational Mobility, Pace of Aging, and Lifespan Among Participants in the Framingham Heart Study. JAMA Netw Open. 2024;7(3):e240655. doi:10.1001/jamanetworkopen.2024.0655.

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Passive video use among toddlers can negatively affect language development

A new study from SMU psychologist Sarah Kucker and colleagues reveals that passive video use among toddlers can negatively affect language development, but their caregiver’s motivations for exposing them to digital media could also lessen the impact.

Results show that children between the ages of 17 and 30 months spend an average of nearly two hours per day watching videos – a 100 percent increase from prior estimates gathered before the COVID pandemic. The research reveals a negative association between high levels of digital media watching and children’s vocabulary development.

Children exposed to videos by caregivers for their calming or “babysitting” benefits tended to use phrases and sentences with fewer words. However, the negative impact on language skills was mitigated when videos were used for educational purposes or to foster social connections – such as through video chats with family members.

“In those first couple years of life, language is one of the core components of development that we know media can impact,” said Kucker, assistant professor of psychology in SMU’s Dedman College of Humanities & Sciences. “There’s less research focused on toddlers using digital media than older ages, which is why we’re trying to understand better how digital media affects this age group and what type of screen time is beneficial and what is not.”

Published in the journal Acta Paediatrica, the study involved 302 caregivers of children between 17 and 30 months. Caregivers answered questions about their child’s words, sentences, and how much time they spend on different media activities each day. Those activities included video/TV, video games, video chat, and e-books, with caregivers explaining why they use each activity with their child. Print book reading was also compared.

Researchers looked at the amount of media use and the reasons provided by caregivers for their children’s media use. These factors were then compared to the children’s vocabulary and length using two or more words together (the mean length of utterance).

Kucker suggests that caregivers need to consider what kind of videos their children are watching (whether for learning or fun) and how they interact with toddlers watching videos. She acknowledges that parents often use digital media to occupy children while they complete tasks. Kucker recommends caregivers consider how much digital media they allow young children and if they can interact with them while using it.

The study’s findings underscore the need for parents, caregivers, and educators to be aware of the potential effects of digital media on language development in children 30 months and under. By understanding the types of digital media children are exposed to and the reasons behind its usage, appropriate measures can be taken to ensure more healthy language development.

Future research by Kucker and her colleagues will continue to explore the types of videos young children watch, how they use screens with others, and if young children watching digital media for two hours is the new normal and, if so, how that impacts language development.

Reference:

Sarah C. Kucker, Lynn K. Perry, Rachel Barr, Variability and patterns in children’s media use and links with language development, Acta Paediatrica, https://doi.org/10.1111/apa.17100.

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Epinephrine nasal spray reversed allergic reactions minutes after administration, results significant for quest to win FDA approval

USA: A small observational study showed that administering one intranasal epinephrine dose immediately after observing a grade 2 allergic reaction led to skipping a second dose of epinephrine within 15 minutes in all 15 pediatric patients.

“Neffy appears to be an effective needle-free option for treating anaphylactic symptoms,” the researchers wrote. 

The intranasal epinephrine spray ARS-1 (also known as neffy), despite being eluded from FDA approval, continues to build its case with findings of resolved allergic symptoms in children and teenagers undergoing an oral food challenge, and a separate study showed that it maintained its potency under extreme temperatures.

It took a median of 16 minutes to fully resolve grade 2 reactions to grade 0. Following the intranasal administration, respiratory, gastrointestinal, skin and mucosal symptoms all began to decrease within the first 5 minutes, reaching full resolution in a median of 15, 15.5, and 35 minutes, respectively, Motohiro Ebisawa, MD, PhD, of the Clinical Research Center for Allergy and Rheumatology at NHO Sagamihara National Hospital in Kanagawa, Japan, said at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.
Gastrointestinal, respiratory, and skin and mucosal symptoms all began to decrease within the first 5 minutes following the intranasal administration, reaching full resolution in a median of 15, 15.5, and 35 minutes, respectively, reported Motohiro Ebisawa, MD, PhD, of the Clinical Research Center for Allergy and Rheumatology at NHO Sagamihara National Hospital in Kanagawa, Japan.
one patient did develop a biphasic allergic reaction about 2 hours and 45 minutes following administration — they were subsequently treated with epinephrine, Ebisawa reported.
The study marks another step in the quest for epinephrine nasal spray to win FDA approval.
The study included 15 pediatric patients experiencing grade 2 or higher allergic symptoms induced by an oral food challenge, leading to 18 observed reactions. Patients’ ages ranged from 6 to 17 years. Participants received a 2.0-mg dose of the intranasal product if they weighed below 30 kg (n=6), otherwise a 2.0-mg dose (n=9).
The one patient with grade 2 cardiovascular (CV) symptoms resolved to grade 0 at 32 minutes after intranasal administration (no grade 1 exists for these symptoms).
Regarding safety, ten patients had a treatment-emergent adverse event: six were deemed nasal spray-related, and four were judged to be a result of the oral food challenge and unrelated to treatment.
Developer ARS Pharmaceuticals tried last year to get FDA approval as the first non-injectable treatment for type 1 allergic reactions such as anaphylaxis but failed. Despite a favourable endorsement from the FDA’s Pulmonary-Allergy Drugs Advisory Committee for use in adult and pediatric patients, the agency ultimately requested that an additional premarket study — on repeat doses under allergen-induced allergic rhinitis conditions — be performed before approval may be considered again.
ARS Pharmaceuticals stated that it would submit a request for a formal dispute resolution to appeal the agency’s decision and resubmit the application to the agency likely in the first half of 2024.
If the intranasal product gets approval on the second try, it would be the first needle-free form of epinephrine.
While allergen avoidance is used for preventing type I allergic reactions, epinephrine remains the first-line emergency treatment in the event of a reaction. Barriers to use include, however, a fear of needles or issues surrounding correct administration that can delay or prevent crucial treatment.
ARS has investigated other factors that might deter patients from epinephrine use, and AAAAI presented other research demonstrating that its nasal spray maintains its potency following prolonged exposure to different temperatures.; 6 months at 40° C (104° F): -13.9%, -27.5%, and -17.2%, respectively, and 3 months at 50° C (122° F): -8.6%, -41.6%, and -56.6%.
Under room temperature conditions for six months, the intranasal product dropped in potency (7.7%), while the autoinjector’s potency dropped by 4.9%, and the prefilled syringe formulation dropped by 10%, the study showed.
Current regulatory specifications for the shelf life of an epinephrine product allow for a 20% reduction in potency.
According to Richard Lowenthal, president and CEO of ARS Pharmaceuticals, while allowing the intranasal product to freeze isn’t ideal, as it will not be available for immediate use, it can still be thawed for use later on.

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