Study Unraveles Impact of Maternal Hypertensive Disorders on Neurodevelopment in Preterm Infants

Recent study aimed to investigate the associations between maternal hypertensive disorders of pregnancy (HDP), particularly preeclampsia, and neurodevelopmental outcomes in preterm infants at 2 years’ corrected age. A regional prospective cohort study of 395 preterm infants born at Յ32 weeks’ gestation was conducted. The main outcomes measured were structural brain magnetic resonance imaging at term-equivalent age and neurodevelopmental assessment using the Bayley Scales of Infant and Toddler Development (BSID), Third Edition, between 22 and 26 months’ corrected age. Preeclampsia affects 2% to 5% of pregnancies and is linked to premature birth and neurodevelopmental deficits due to disruptions in fetal brain development. Hypertensive disorders of pregnancy, including preeclampsia, impact 5% to 15% of pregnancies and share similar mechanisms with preeclampsia that can affect brain development, leading to cognitive, motor, and behavioral issues in children. While HDP exposure has been associated with suboptimal neurodevelopmental outcomes in full-term infants, findings in preterm infants have been inconsistent, with some studies showing worse outcomes, while others suggest a protective role.

Neurodevelopmental Outcomes

In the cohort of preterm infants, HDP-exposed infants had lower cognitive and language scores on the BSID at 2 years’ corrected age. Preeclampsia-exposed infants showed greater reductions in scores. Mediation analyses revealed that brain abnormalities partially mediated the effect of HDP on lower cognitive scores. Adjusting for histologic chorioamnionitis, a risk factor for preterm birth and adverse neurodevelopmental outcomes, was crucial in this study.

Study Strengths and Recommendations

The study’s strengths included population representation, precise exposure, and outcome assessments, standardized brain MRI scoring, and rigorous confounder control. Notably, the study highlighted the importance of addressing biases from inadequate adjustment of confounders and inappropriate adjustment of intermediate variables in previous research. The findings underscored the need for closer monitoring and early interventions in HDP-exposed preterm infants to improve long-term outcomes. Understanding the mechanisms through which HDP affects neurodevelopment, such as its impact on early brain development, is crucial for refining risk stratification and enhancing early identification of developmental delays for targeted interventions. Enhanced efforts to prevent or treat maternal hypertension may help reduce the risk of abnormal brain development and neurodevelopmental deficits in preterm infants.

Key Points

– The study aimed to investigate the associations between maternal hypertensive disorders of pregnancy (HDP), particularly preeclampsia, and neurodevelopmental outcomes in preterm infants at 2 years’ corrected age. Preeclampsia is linked to premature birth and neurodevelopmental deficits due to disruptions in fetal brain development.

– HDP exposure in preterm infants was associated with lower cognitive and language scores on the Bayley Scales of Infant and Toddler Development (BSID) at 2 years’ corrected age, with more significant reductions in scores observed in preeclampsia-exposed infants.

– Brain abnormalities partially mediated the effect of HDP on lower cognitive scores in preterm infants. Adjusting for histologic chorioamnionitis, a risk factor for adverse neurodevelopmental outcomes, was crucial in the analysis.

– The study emphasized the importance of population representation, precise exposure and outcome assessments, standardized brain MRI scoring, and rigorous confounder control. It highlighted the need to address biases in previous research related to inadequate adjustment of confounders and inappropriate adjustment of intermediate variables.

– Early monitoring and interventions are recommended for HDP-exposed preterm infants to improve long-term outcomes. Understanding the mechanisms through which HDP affects neurodevelopment, particularly its impact on early brain development, is crucial for risk stratification and early identification of developmental delays.

– Preventing or treating maternal hypertension may help reduce the risk of abnormal brain development and neurodevelopmental deficits in preterm infants. Efforts in this direction could lead to improved outcomes for preterm infants exposed to hypertensive disorders during pregnancy.

Reference –

Shipra Jain et al. (2025). Maternal Hypertension And Adverse Neurodevelopment In A Cohort Of Preterm Infants. *JAMA Network Open*, 8. https://doi.org/10.1001/jamanetworkopen.2025.7788.

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Empagliflozin Not Linked to Increased Risk of Urinary Tract Cancers: Study

Empagliflozin use in patients with type 2 diabetes (T2D) has not been shown to have a higher risk of urinary tract cancers (UTCs), such as bladder and renal cancers, compared to dipeptidyl peptidase-4 inhibitors (DPP-4i), according to researchers. The research provides reassurance about the cancer safety profile of empagliflozin, a widely prescribed sodium-glucose co-transporter 2 (SGLT2) inhibitor for the treatment of T2D. The study was published in Diabetes Obesity & Metabolism by Niklas S. and colleagues.

The research was a non-interventional, retrospective cohort study among adult patients with T2D who were new users of empagliflozin or DPP-4 inhibitors. The data covered the period between 2014 and 2020 in Sweden and Finland, and up to 2021 in the UK. A total of 151,055 propensity score-matched patients were contributed from the three nations. The analysis used an “as-treated” strategy and adopted a latency of 180 days after the first prescription to minimize confounding by the premature development of cancer.

The researchers calculated incidence rates (IRs) and hazard ratios (HRs) for UTCs by using Cox regression models that were controlled for age, sex, comorbidities, and other potential confounders. Random-effects meta-analysis was employed to combine results by country.

Results

  • The matched cohort consisted of 151,055 patients with T2D, the majority being female (between 59.6% and 67.8%), and the mean empagliflozin user’s age ranged between 57.0 and 63.2 years across countries.

The meta-analysis demonstrated:

  • There was no significant increase in total UTC risk among individuals using empagliflozin when compared to those using DPP-4i (adjusted HR = 0.88; 95% CI: 0.66–1.17).

  • Risk of bladder cancer was likewise unaffected (adjusted HR = 0.91; 95% CI: 0.63–1.33).

  • Risk for renal cancer was also not increased (adjusted HR = 0.89; 95% CI: 0.57–1.38).

In this multinational, large-scale cohort study, empagliflozin was not linked with a higher risk of urinary tract, bladder, or kidney cancers compared with DPP-4 inhibitors in adults with type 2 diabetes. The findings indicate the long-term safety of empagliflozin in terms of cancer risk and support its position in holistic diabetes management.

Reference:

Schmedt, N., Alhamdow, A., Tskhvarashvili, G., Saarelainen, L., Qiao, X., Lobier, M., & Hoti, F. (2025). Post-authorisation safety study to assess the risk of urinary tract cancer in people with type 2 diabetes initiating empagliflozin: A multi-country European study. Diabetes, Obesity & Metabolism. https://doi.org/10.1111/dom.16477

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Health Ministry Plans Licence Suspension for Drugs Failing Quality Standards: Report

New Delhi: The Union Health Ministry is planning a regulatory overhaul that could result in the immediate suspension of product licenses for drugmakers whose products are declared not of standard quality (NSQ) by government testing laboratories.

The move, aimed at ensuring drug quality and public safety, is currently under discussion with various state regulators.

According to a recent media report in the Economic Times, the government intends to issue a notification soon, mandating swift punitive action against companies whose products fail quality tests. Discussions are also underway with stakeholders including state governments and pharmaceutical industry bodies.

The proposal comes in the backdrop of concerns over the rising number of NSQ alerts issued by the Central Drugs Standard Control Organisation (CDSCO). While the health ministry leads the initiative, the CDSCO is in active consultation with pharma associations that have expressed strong reservations about the proposed measures.

Earlier, the Drugs Technical Advisory Board (DTAB) — the apex advisory body on technical matters related to drugs under the CDSCO — had recommended the idea of prompt regulatory action in such cases. As per the official minutes of the board meeting:

“The board noted that it is very important that once a drug is declared NSQ, the license of such product shall be suspended immediately in public interest unless a satisfactory corrective action and preventive action (CAPA) is submitted by such manufacturers. After detailed deliberation, DTAB recommended for the appropriate amendment in the Drug Rules in this regard and the suspension product licence should be revoked only after root cause analysis and corresponding CAPA has been implemented.”

A senior government official, speaking to ET on condition of anonymity, added:

“The health ministry and the CDSCO is taking a step forward by taking views of the states and pharma bodies as it would require a notification.”

Also Read: Substandard Drugs to Face Immediate License Suspension Under DTAB’s New Recommendation

Meanwhile, industry groups have voiced concern over the draft approach. In its representation to the government, the Federation of Pharma Entrepreneurs (FOPE) argued that NSQ incidents are often not due to intentional wrongdoing but technical lapses.

“NSQ is a global phenomenon, and most of the time, it is due to technical issues without any wrongful intent,” FOPE stated.

Pharma associations also pointed to inconsistencies in test results from government labs and raised questions about GLP (Good Laboratory Practices) compliance.

“This has been a long-standing concern. It is also necessary that the NSQ investigation includes a review of records and data from government testing laboratories, as well as GLP compliance by the Drugs Inspector,” a member of one such group told ET.

“It has been found that in many cases, samples declared NSQ by government labs, when challenged and tested by CDL Kolkata, have been declared as Standard Quality by CDL Kolkata, which is an appellate laboratory,” the person added.

In addition to questioning the reliability of some NSQ assessments, drugmakers emphasized the need to focus on enhancing the recall mechanism rather than imposing automatic licence suspensions.

FOPE also cautioned the ministry to undertake a detailed impact analysis before finalising the proposal, noting the potential unintended consequences:

“We fear it may lead to malpractices in the profession, and genuine manufacturers with investments of hundreds of crores in plant setup, product development, technical team development, brand development, business development, and goodwill, may be adversely impacted if actions like the suspension of product permission are taken without proper investigation.”

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Physical Activity Reduces Gout Risk in Hyperuricemia Patients, Says Machine Learning Study

Using machine learning models researchers have found in a new study that increased physical activity and reduced sedentary time significantly lower the risk of developing gout in individuals with hyperuricemia.

Individuals with hyperuricemia (HUA) are widely recognized as being at increased risk for gout. This study aimed to investigate how physical activity (PA) duration and sedentary duration impact gout risk in individuals with HUA and to develop predictive models to assess their risk of developing gout. They retrospectively collected clinical characteristics of 8057 individuals with HUA from the National Health and Nutrition Examination Survey (NHANES) consortium for the period 2007–2018. By developing and comparing four classic machine learning algorithms, the best-performing Random Forest (RF) model was selected and combined with the SHAP interpreting algorithm to analyze the dose–response relationship between PA duration, sedentary time, and gout risk. Additionally, the RF model was used to identify the most critical factors influencing gout risk and to develop a free online tool for predicting gout risk in HUA individuals. Results: The RF model outperformed others, achieving a Receiver Operating Characteristic (ROC) of 0.957 in the training cohort and 0.799 in the testing cohort. In the test cohort, it demonstrated an accuracy of 0.778, a Kappa of 0.247, a sensitivity of 0.701, a specificity of 0.785, a positive predictive value of 0.224, a negative predictive value of 0.967, and an F1 score of 0.340. SHAP analysis revealed the following insights: (1) hypertension, serum uric acid, age, gender, and BMI were identified as the top five factors for gout risk; (2) factors such as higher serum uric acid levels, age, BMI, creatinine, sedentary duration, lower PA, hypertension, male sex, and diabetes were associated with an elevated risk of gout; and (3) a PA duration of 1–7 h per week was linked to a lower risk of gout, while sedentary time exceeding 6 h per day increased gout risk, regardless of age, sex, or comorbidities. They encourage individuals with HUA to engage in 1–7 h of PA per week and limit daily sedentary time to less than 6 h to reduce gout risk. The developed prediction model is freely available as a web-based app at: https://sasuki.shinyapps.io/GoutRisk/.

Reference:

Jiao, Y., Cheng, Z., Lan, Z., Kan, S. and Du, Y. (2025), Exploring the Impact of PA and Sedentary Behavior on Gout Risk in Hyperuricemia: Insights From Machine Learning and SHAP Analysis. Int J Rheum Dis, 28: e70238. https://doi.org/10.1111/1756-185X.70238

Keywords:

Physical, Activity, Reduces, Gout, Risk, Hyperuricemia, Patients, Says Machine, Learning, Study, International Journal of Rheumatic Diseases, Jiao, Y., Cheng, Z., Lan, Z., Kan, S. and Du, Y

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Bharat Serums Gets CDSCO Panel Nod for Phase III Trial of IVIG in Chronic ITP

New Delhi: Bharat Serums and Vaccines has received approval from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial of Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% Solution.

This came after the firm presented the revised protocol — updated as per the recommendations given by the committee during the SEC meeting held on February 11, 2025 — for the proposed Phase III clinical trial titled:

“An Open-Label, Multicenter, Phase III Clinical Study in India to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous Use (IVIG) in Chronic Immune Thrombocytopenia (ITP)”, vide Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0, dated April 17, 2025.

Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% solution is a plasma-derived product containing primarily IgG antibodies, used to enhance immunity in individuals with immune deficiencies or autoimmune disorders. Administered intravenously, it helps the body fight infections and regulate immune responses.

At the recent SEC (Hematology) meeting held on June 10, 2025, the expert panel reviewed the revised protocol and, after detailed deliberation, “recommended the grant of permission to conduct the Phase III clinical trial as per revised Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0 dated 17.04.2025.”

Also Read: Sun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDC

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SEC Clears Hemopurifier Device for Cancer Study in Indian Patients

New Delhi: In a step toward advancing medical device-based cancer care, the Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has granted permission to conduct a pilot clinical investigation of the Hemopurifier device in India.

The proposal, submitted by Qualtran Consulting, was reviewed during the 19th SEC (Oncology) meeting held on 5th June 2025 at CDSCO headquarters, New Delhi.

The firm presented Study Protocol No. AEMD-2024-01-Oncology-India, dated 24th May 2024, a proposal for grant of permission to conduct Pilot Clinical Investigation on proposed medical device Hemopurifier in the country on Indian population before the committee.

After detailed deliberation the committee recommended for;

“The grant of permission to conduct of Pilot Clinical Investigation to prove safety and feasibility of the device in removing circulating exosomes of individuals with solid malignancies on Indian Population as per Study Protocol no. AEMD-2024-01-Oncology-India dated 24.05.2024.”

The Hemopurifier is a blood filtration medical device designed to selectively remove circulating exosomes and tumor-derived particles from the bloodstream. These components are known to play a role in tumor progression, immune evasion, and resistance to cancer therapies.

Also Read: 58 Drug Batches, Including Dexona Fail CDSCO Quality Standards

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AI in health care needs patient-centered regulation to avoid discrimination, say experts

A new commentary published in the Journal of the Royal Society of Medicine warns that current risk-based regulatory approaches to artificial intelligence (AI) in health care fall short in protecting patients, potentially leading to over- and undertreatment as well as discrimination against patient groups.

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Newborns require better care to improve survival and long-term health, global report says

More effective platforms for drug and medical device development and better cross-sector engagement are urgently required to prevent the ‘unacceptably high’ newborn death rate, according to a global report.

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Surgery plus speech therapy linked to improved language after stroke

Combining neck surgery with intensive speech therapy is associated with greater improvements in a person’s ability to communicate after a stroke than intensive speech therapy alone, finds a clinical trial published by The BMJ.

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GP performance pay fails to drive lasting changes in quality of care, finds study

Introducing performance-related pay for UK general practices initially improved quality of care, but did not seem to provide lasting improvements beyond that expected by previous trends, finds a study published by The BMJ.

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