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Nevin Manimala Statistics

Incidence, outcomes and risk factors of postoperative urinary retention in patients undergoing primary total knee arthroplasty: a national inpatient sample database study

BMC Surg. 2025 Apr 28;25(1):186. doi: 10.1186/s12893-025-02930-9.

ABSTRACT

BACKGROUND: Postoperative urinary retention (POUR) was reported as a common complication in patients undergoing primary total knee arthroplasty (pTKA), but descriptions of its prevalence and negative outcomes vary widely and remain inadequately studied.

METHODS: A retrospective cohort study was conducted using the National Inpatient Sample database from 2005 to 2014. The annual incidence, baseline characteristics, and inpatient outcomes of POUR after pTKA were recorded. Logistic regression analysis was performed to estimate potential predictors of POUR. Statistical significance was defined as P < 0.01.

RESULTS: A total of 1,228,621 patients undergoing pTKA were identified. The incidence of POUR after pTKA is increasing annually from 2005 (1.51%, 95%CI 1.44-1.59%) to 2014 (2.29%, 95%CI 2.21-2.37%), and the cumulative incidence of POUR was 1.91% (95%CI 1.89-1.93%). POUR was significantly associated with higher Charlson Comorbidity Index and Elixhauser Comorbidity Index scores, and higher medical costs. In patients experiencing pTKA, the Top 5 most significant risk factors for developing POUR were male gender (odds ratio [OR] = 3.40; 95% confidence interval [CI] 3.30-3.51; P < 0.0001), fluid and electrolyte disorders (OR = 2.02; 95% CI 1.94-2.10; P < 0.0001), age over 60 (OR = 1.97; 95% CI 1.89-2.05; P < 0.0001), paralysis (OR = 1.78; 95% CI 1.46-2.17; P < 0.0001), and psychoses (OR = 1.57; 95% CI 1.43-1.72; P < 0.0001). Although POUR did not result in higher inpatient mortality (0.1% vs. 0.07%, P = 0.1242), it may be associated with the occurrence of other complications such as acute myocardial infarction (0.42% vs. 0.20%, P < 0.0001), pulmonary embolism and infarction (0.80% vs. 0.42%, P < 0.0001), acute renal failure (6.06% vs. 1.49%, P < 0.0001), deep venous thrombosis (0.71% vs. 0.45%, P < 0.0001), acute posthemorrhagic anemia (28.89% vs. 19.45%, P < 0.0001), and infection (0.29% vs. 0.15%, P < 0.0001).

CONCLUSIONS: Although POUR has no effect on inpatient mortality, our large-scale national study provides new insights that it increases postoperative complications and impairs clinical outcomes. Given the increasing incidence of POUR, early identification of high-risk patients, particularly those with identified comorbidities, should be prioritized. Preventive strategies, such as optimized perioperative fluid management, may help mitigate the risk of POUR. Future research should focus on developing preventive strategies to mitigate its impact.

PMID:40296087 | DOI:10.1186/s12893-025-02930-9

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Effectiveness of prior intra-articular corticosteroid injection in elderly patients with knee osteoarthritis undergoing progressive resistance training: a randomized controlled trial

Adv Rheumatol. 2025 Apr 28;65(1):21. doi: 10.1186/s42358-025-00452-9.

ABSTRACT

OBJECTIVE: To evaluate the effectiveness of intra-articular injections (IAIs) with triamcinolone hexacetonide (TH) combined with a progressive resistance exercise program (PREP) in improving pain, function, muscle strength, and quality of life in elderly patients with knee osteoarthritis (OA).

METHODS: Fifty-nine elderly individuals with knee OA were randomized into three groups: IAI with TH (IAI-TH) + PREP, IAI with saline solution (IAI-SS) + PREP, and IAI with placebo + PREP. The IAIs were administered once, one week before starting PREP, which was performed twice weekly for 12 weeks. Outcomes assessed at baseline and at 2, 6, and 12 weeks post-IAI included pain (Numerical Pain Scale – NPS), swelling, function (Western Ontario and McMaster Universities Osteoarthritis Index – WOMAC), quality of life (Short Form-36 – SF-36), performance tests (Six-Minute Walk Test – 6MWT, Timed Up and Go Test – TUGT, Short Physical Performance Battery – SPPB), and muscle strength (one-repetition maximum test – 1RM). Due to the COVID-19 pandemic, only 15 participants per group completed the study protocol.

RESULTS: All groups showed significant intragroup improvements over time in pain, function, muscle strength, and quality of life. However, no statistically significant differences were found between the groups for any of the assessed outcomes. The bodily pain domain of the SF-36 and analgesic consumption were the only measures showing differences over time.

CONCLUSION: The combination of IAI-TH and a 12-week PREP (twice weekly) was not superior to IAI-SS or placebo combined with the same PREP in improving pain, function, or quality of life in elderly patients with knee OA. These findings highlight the role of exercise as a key therapeutic strategy, regardless of prior IAI. Future studies with larger sample sizes and long-term follow-ups are needed to better assess the role of intra-articular corticosteroid injections in OA rehabilitation.

CLINICAL TRIAL NUMBER: ensaiosclinicos.gov.br (RBR-556md5g). Registered 27 October 2022.

PMID:40296068 | DOI:10.1186/s42358-025-00452-9

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Suicidal ideation, attempted suicide and determinants among prisoners in Ethiopia 2024: a systematic review and meta-analysis

BMC Psychiatry. 2025 Apr 28;25(1):426. doi: 10.1186/s12888-025-06869-2.

ABSTRACT

INTRODUCTION: Prisoners face severe restrictions on freedom and social connections, negatively impacting their mental health and increasing suicidal thoughts and attempts. Suicide is a significant public health concern, with rates among inmates much higher than in the general population. Research indicates that suicidal ideation is common among convicts. Despite the alarming prevalence of suicidal ideation and attempts among inmates, many countries lack comprehensive data on prison suicides, highlighting the need for targeted preventive strategies. This systematic review and meta-analysis aims to synthesize findings of different studies and pool them to provide a comprehensive figure of suicidal ideation and attempts among prisoners and to inform policymakers on improving health services for vulnerable inmates.

OBJECTIVE: This study comprehensively assessed and pooled the prevalence of suicidal ideation and attempts and the effect size of determinants among prisoners in Ethiopia.

METHODS: Systematic searches for observational studies were conducted in various databases, including PubMed (MEDLINE), CINAHL (EBSCO), Embase, Web of Science, HINARI, Science Direct, Google Scholar, Mednar, and the Cochrane Library. Observational studies involving inmates from 2015 to 2024 were included, except those who fulfill exclusion criteria. Four research groups independently selected studies, extracted data, and assessed quality. Nine studies involving 4435 prisoners were included. A meta-analysis using random-effects models was performed.

RESULTS: A total of nine studies involving 4435 study participants were included in the review. This study of studies revealed that the pooled prevalence of suicidal ideation and attempted suicide among prisoners in Ethiopia was 23.28% (95% confidence intervals (CI): 12.26%, 34.29%) and 10.20% (95% CI: 8.63%, 11.78%), respectively. Depression, poor social support, suicidal history, and previous mental illness were significantly associated. Statistically significant heterogeneity across included studies was found both for suicidal ideation (I2 = 98.74%, p ≤ 0.001) and suicidal attempts (I2 = 73.05%, p ≤ 0.001). Egger’s test revealed publication bias in studies on suicidal ideation (p = 0.001) but not in studies on suicidal attempts (p = 0.271).

CONCLUSION: This study revealed a high prevalence of suicidal ideation and attempts among prisoners. These public health problems are significantly determined by depression, poor social support, mental illness, and family history of suicide. The review advocates for integrating mental health services in prisons, including routine screenings, while emphasizing the need to combat the marginalization of prisoners for meaningful change.

TRIAL REGISTRATION: The protocol for this study was submitted and registered in PROSPERO on 03 May 2024, and the first version of this protocol was published on 14 May 2024 with the PROSPERO ID of CRD42024542958.

PMID:40296065 | DOI:10.1186/s12888-025-06869-2

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Prevalence of food and inhalant allergies in infants and children from the Nanhai area of Foshan city

BMC Pediatr. 2025 Apr 28;25(1):334. doi: 10.1186/s12887-025-05664-y.

ABSTRACT

BACKGROUND: The aim of our research was to explore the distribution characteristics of the most common food and inhalant allergens in children from Foshan city in Southwest China to provide evidence for the development of prevention and treatment strategies for allergic diseases in children.

METHODS: A total of 635 children who attended the Sixth Affiliated Hospital, South China University of Technology, were included in our retrospective study from February 2013 to October 2019. The sensitivity of immunoglobulin E (IgE) for 20 allergens (10 inhalant allergens and 10 food allergens) was determined. Statistical analysis was performed to analyze differences in the percentage of allergens among individuals according to sex, age and season.

RESULTS: Of the 635 patients, 200 tested positive for allergies. Dust mites were the most common inhalant allergens, followed by dog hair. The highest percentage of positive house dust mite sensitization was in the summer. Among the food allergens, individuals most frequently tested positive for wheat and milk allergies. The percentage of individuals with milk and egg allergies decreased with increasing age.

CONCLUSION: The most common allergens found in children from Foshan were dust mites, dog hair, wheat, tree nuts (hazelnut and pistachio), milk and peanuts. The results obtained could be helpful in determining the etiology of allergic diseases.

PMID:40296060 | DOI:10.1186/s12887-025-05664-y

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Global and China burden of hormone-related cancers and risk factors, 1990-2021: results from the Global Burden of Disease Study 2021

BMC Public Health. 2025 Apr 28;25(1):1566. doi: 10.1186/s12889-025-22768-3.

ABSTRACT

BACKGROUND: Updated data on hormone-related cancers (HRCs) are crucial for their prevention, management, and treatment, aligning with the UN’s Sustainable Development Goals. This study focuses on HRCs: breast, thyroid, uterine, ovarian, prostate, and testicular cancers. Despite their significance, comparative studies on these cancers are limited.

METHODS: Data for incidence, prevalence, mortality, disability-adjusted life years (DALYs), years lived with disability (YLDs), and years of life lost (YLLs) related to HRCs were obtained from the Global Burden of Disease Study 2021. Statistical analyses were performed using R and Joinpoint Software. Age-standardized rates (ASR), percentage changes (1990-2021), annual percent change (APC) and average annual percent change (AAPC) are used to examine trends and risk factors associated with HRCs across various years, genders, and age groups, both in China and globally.

FINDINGS: In 2021, China reported 659450 incidence cases of six HRCs, including 527009 cases (95% UI: 398030, 684814) in females and 132442 cases (89701, 181113) in males, reflecting a 29.97% increase since 1990. Deaths attributed to HRCs totaled 176526, with 130281 cases (99207, 166654) among females and 46245 cases (33049, 62510) among males, marking an 11.07% increase during the same period. The age-standardized incidence rates (ASIR) for HRCs in China were 10.70 (38.19, 65.86) per 100,000 for females and 13.87(9.50, 18.71) for males, in contrast to global rates of 17.07(62.11, 72.57) for females and 39.21(35.75, 41.69) for males. Age-standardized death rates (ASDR) were 3.54(9.22, 15.50) for females and 5.86(4.16, 7.83) for males, compared to higher global ASDRs of 6.17(19.49, 22.98) and 13.73(12.06, 14.78),respectively. From 1990 to 2021, China and the global population saw significant increases in ASIR for most cancers, except global ovarian cancer (AAPC = -0.229). Female HRCs mortality, YLLs, and DALYs declined significantly, particularly for uterine cancer. Conversely, Chinese males experienced increased mortality, YLLs, and DALYs for breast and thyroid cancers. Testicular cancer prevalence increased among Chinese males (AAPC = 7.329). Specifically, female breast cancer mortality in China decreased from 2011 to 2014 (APC = -2.82). Uterine cancer mortality dropped sharply from 2011 to 2015 (APC = -7.91). Thyroid cancer mortality declined from 2000 to 2007 (APC = -3.54), while ovarian cancer mortality decreased from 2000 to 2004 (APC = -3.33). Male breast cancer incidence peaked around 2010, and testicular cancer incidence rose significantly from 2011 to 2015 (APC = 7.77). All above changes were statistically significant (P < 0.05). Regarding age distribution characteristics, female HRCs consistently peak in the 60-74 age group globally and in China, whereas male HRCs show greater variability. In this age bracket, female breast cancer incidence reaches 348.90 (270.60, 440.16) in China versus 483.55 (449.97, 516.08) globally, while uterine cancer rates are 71.74 (52.18, 99.03) in China compared to 151.71 (138.55, 163.03) worldwide. Similarly, ovarian cancer peaks at 39.29 (28.29, 51.02) in China and 69.95 (63.59, 75.55) globally. Prostate cancer incidence also peaks in this group, with rates of 121.87 (84.48, 168.23) in China contrasting sharply with 534.72 (491.27, 568.09) globally. Conversely, testicular cancer shows a distinct pattern, peaking in the younger age group of 25-44 years, with incidences of 5.95 (4.44, 7.85) in China and 19.21 (18.04, 20.56) globally. The 25-44 age group also remains significant for thyroid cancer, with incidences of 23.31 (17.01, 32.52) in China and 31.57 (27.61, 36.30) globally. In terms of risk factors, smoking contributed to an ASR of 0.22 (0.16, 0.27) deaths globally, while alcohol accounted for 0.39 (0.27, 0.54) deaths. In China, low physical activity resulted in an ASR of 0.18 (0.03, 0.33) deaths, where high BMI notably increased risks for female HRCs. Environmental factors significantly impacted global ovarian cancer, contributing 0.12 (0.06, 0.19) deaths, while smoking influenced prostate cancer mortality, with an ASR of 0.36 (0.16, 0.60) deaths.

INTERPRETATION: Our study reveals that rising incidence rates and age-specific patterns of female HRCs in China and globally are largely associated with shifts in lifestyle and dietary habits. To address this issue, it is essential to implement tailored prevention strategies for different cancer types and age groups and enhance management of risk factors, especially considering the growing burden of diseases affecting the elderly due to population aging.

PMID:40296059 | DOI:10.1186/s12889-025-22768-3

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Effects of recombinant human sclerostin on proliferation and migration in human cementoblast lineage cells

Arch Oral Biol. 2025 Apr 19;175:106273. doi: 10.1016/j.archoralbio.2025.106273. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the effects of sclerostin on the proliferation and migration of human cementoblasts and periodontal ligament cells.

DESIGN: Sclerostin expression in human cementoblasts and periodontal ligament cells was assessed using immunochemical staining. Human cementoblasts and periodontal ligament cells were cultured and treated with 100 ng/mL of recombinant human sclerostin. Cell proliferation was evaluated using a 5-bromo-2-deoxyuridine enzyme-linked immunosorbent assay and quantified with a live-cell imaging and analysis platform (IncuCyte® S3 system). Furthermore, sclerostin’s impact on apoptosis in human cementoblasts and periodontal ligament cells was evaluated using IncuCyte® Caspase-3/7 green dye. Additionally, cell migration was analyzed through quantitative wound healing assessment using the IncuCyte® S3 system. Polymerase chain reaction, enzyme-linked immunosorbent assay, and Western blotting were then performed to confirm the effect of sclerostin on CEMP-1. The data obtained were statistically analyzed using the Mann-Whitney U test.

RESULTS: Intracellular sclerostin localization in human cementoblasts and periodontal ligament cells were confirmed form the immunochemical staining. The sclerostin-treated group showed suppressed proliferation and migration of human cementoblasts and periodontal ligament cells compared with the non-treated group. Furthermore, the sclerostin-treated group showed significantly elevated caspase-3/7 activity compared with the non-treated group. However, the addition of sclerostin did not result in any significant changes in CEMP-1.

CONCLUSION: Sclerostin is crucial in regulating the proliferation and migration of cementoblasts and periodontal ligament cells. This highlights its importance in regenerating the cementum and periodontal ligament.

PMID:40294473 | DOI:10.1016/j.archoralbio.2025.106273

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Minimally invasive radical prostatectomy versus open radical prostatectomy: A systematic review and meta-analysis of randomized control trials

Clinics (Sao Paulo). 2025 Apr 27;80:100636. doi: 10.1016/j.clinsp.2025.100636. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the comparative outcomes of Minimally Invasive Radical Prostatectomy (MIRP) versus Open Radical Prostatectomy (ORP) to treat localized prostate cancer, using only Randomized Controlled Trials (RCTs) to ensure high-quality evidence.

METHOD: A systematic review and meta-analysis were conducted in accordance with PRISMA guidelines, focusing solely on RCTs comparing MIRP (robot-assisted or laparoscopic surgery) and ORP. Literature searches across multiple databases, including Cochrane Library, Medline, Embase, Lilacs, Scopus, Web of Science, NIH, Clinical Trials, and EU Clinical Trials Register, identified studies meeting predefined PICOT criteria. Four RCTs met inclusion criteria ‒ two representing the same cohort of patients ‒ and were analyzed for perioperative, functional, and oncologic outcomes. Quality assessment utilized the ROB-2 tool to gauge the risk of bias.

RESULTS: Three RCTs encompassing 1051 patients were analyzed. MIRP demonstrated statistically significant benefits over ORP in terms of reduced perioperative blood loss (Standardized Mean Difference [SMD = -3.058], p = 0.006), lower transfusion rates (Odds Ratio [OR = 0.137]; p = 0.009), and fewer overall complications (OR = 0.465; p = 0001). However, no significant differences were found in long-term oncologic and functional outcomes, including urinary continence and erectile function. Positive surgical margins and additional treatments also did not differ significantly between groups.

CONCLUSION: This systematic review and meta-analysis of RCTs indicated that MIRP offers perioperative advantages over ORP, supporting its role as a safe and effective option for localized prostate cancer.

PMID:40294454 | DOI:10.1016/j.clinsp.2025.100636

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A Digital Outpatient Service With a Mobile App for Tailored Care and Health Literacy in Adults With Long-Term Health Service Needs: Multicenter Nonrandomized Controlled Trial

J Med Internet Res. 2025 Apr 28;27:e60343. doi: 10.2196/60343.

ABSTRACT

BACKGROUND: Patients with long-term health needs are often expected to actively participate in outpatient care, assuming that they have appropriate health literacy and digital health literacy. However, the association between participation in a digital outpatient service and health literacy remain unclear.

OBJECTIVE: This study aims to evaluate whether digital outpatient care for 6 months improved health literacy, health-related quality of life (HRQoL), digital/eHealth literacy, and the use of health care services compared with usual care.

METHODS: We conducted a multicenter nonrandomized trial with 1 intervention arm and 1 control arm. Patients aged ≥18 years receiving outpatient care in the pain, lung, neurology, or cancer departments at 2 Norwegian university hospitals were allocated in a 1:2 ratio, favoring the intervention arm. The intervention arm received digital outpatient care using tailored patient-reported outcome measures, self-monitoring, and chats for timely contact with the outpatient clinic. Patient responses were assessed by health care workers via a dashboard with a traffic light system to draw attention to the most urgent reports. The control arm received usual care. The data were collected at baseline and after 3 and 6 months. The primary outcome was the change in health literacy according to the Health Literacy Questionnaire domain understanding health information well enough to know what to do from baseline to 6 months. The mean difference in change between the 2 treatment arms was the effect measure. The secondary outcomes were additional domains from the Health Literacy Questionnaire, digital/eHealth literacy, HRQoL, acceptability of the digital intervention, and health service use.

RESULTS: Overall, 162 patients were recruited, 55 (34%) in the control arm and 107 (66%) in the intervention arm, with a 17.3% attrition rate after 6 months. There was no statistically significant difference in the primary outcome, “understanding health information well enough to know what to do,” between the arms at 6 months (mean difference -0.05, 95% CI -0.20 to 0.10; P=.53). After 3 months, the health literacy domains actively managing my own health (-0.15, 95% CI -0.30 to -0.00; P=.048) and understanding health information well enough to know what to do (-0.17, 95% CI -0.34 to -0.00; P=.03), as well as both physical (-3.29, 95% CI -5.62 to -0.96; P=.006) and mental HRQoL (-3.08, 95% CI -5.64 to -0.52; P=.02), improved in the digital outpatient intervention arm compared with the control arm.

CONCLUSIONS: This study explored digital outpatient care. Although no statistical differences were observed in patients’ health literacy after 6 months, our data indicate an improvement in health literacy domains and HRQoL at 3 months. The participants reported high satisfaction with the digital outpatient care intervention, and our findings highlight the potential of digital interventions in outpatient care.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05068869; https://clinicaltrials.gov/ct2/show/NCT05068869.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/46649.

PMID:40294411 | DOI:10.2196/60343

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AI in Home Care-Evaluation of Large Language Models for Future Training of Informal Caregivers: Observational Comparative Case Study

J Med Internet Res. 2025 Apr 28;27:e70703. doi: 10.2196/70703.

ABSTRACT

BACKGROUND: The aging population presents an accomplishment for society but also poses significant challenges for governments, health care systems, and caregivers. Elevated rates of functional limitations among older adults, primarily caused by chronic conditions, necessitate adequate and safe care, including in-home settings. Traditionally, informal caregiver training has relied on verbal and written instructions. However, the advent of digital resources has introduced videos and interactive platforms, offering more accessible and effective training. Large language models (LLMs) have emerged as potential tools for personalized information delivery. While LLMs exhibit the capacity to mimic clinical reasoning and support decision-making, their potential to serve as alternatives to evidence-based professional instruction remains unexplored.

OBJECTIVE: We aimed to evaluate the appropriateness of home care instructions generated by LLMs (including GPTs) in comparison to a professional gold standard. Furthermore, it seeks to identify specific domains where LLMs show the most promise and where improvements are necessary to optimize their reliability for caregiver training.

METHODS: An observational, comparative case study evaluated 3 LLMs-GPT-3.5, GPT-4o, and Microsoft Copilot-in 10 home care scenarios. A rubric assessed the models against a reference standard (gold standard) created by health care professionals. Independent reviewers evaluated variables including specificity, clarity, and self-efficacy. In addition to comparing each LLM to the gold standard, the models were also compared against each other across all study domains to identify relative strengths and weaknesses. Statistical analyses compared LLMs performance to the gold standard to ensure consistency and validity, as well as to analyze differences between LLMs across all evaluated domains.

RESULTS: The study revealed that while no LLM achieved the precision of the professional gold standard, GPT-4o outperformed GPT-3.5, and Copilot in specificity (4.6 vs 3.7 and 3.6), clarity (4.8 vs 4.1 and 3.9), and self-efficacy (4.6 vs 3.8 and 3.4). However, the models exhibited significant limitations, with GPT-4o and Copilot omitting relevant details in 60% (6/10) of the cases, and GPT-3.5 doing so in 80% (8/10). When compared to the gold standard, only 10% (2/20) of GPT-4o responses were rated as equally specific, 20% (4/20) included comparable practical advice, and just 5% (1/20) provided a justification as detailed as professional guidance. Furthermore, error frequency did not differ significantly across models (P=.65), though Copilot had the highest rate of incorrect information (20%, 2/10 vs 10%, 1/10 for GPT-4o and 0%, 0/0 for GPT-3.5).

CONCLUSIONS: LLMs, particularly GPT-4o subscription-based, show potential as tools for training informal caregivers by providing tailored guidance and reducing errors. Although not yet surpassing professional instruction quality, these models offer a flexible and accessible alternative that could enhance home safety and care quality. Further research is necessary to address limitations and optimize their performance. Future implementation of LLMs may alleviate health care system burdens by reducing common caregiver errors.

PMID:40294407 | DOI:10.2196/70703

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Extended Caffeine for Apnea in Moderately Preterm Infants: The MoCHA Randomized Clinical Trial

JAMA. 2025 Apr 28. doi: 10.1001/jama.2025.5791. Online ahead of print.

ABSTRACT

IMPORTANCE: Hospitalization of moderately preterm infants may be prolonged while waiting for apnea of prematurity to resolve after discontinuing caffeine.

OBJECTIVE: To evaluate whether extending caffeine treatment reduces the duration of hospitalization.

DESIGN, SETTING, AND PARTICIPANTS: From February 2019 to December 2022, this randomized clinical trial in 29 US hospitals enrolled infants born at 29 to 33 weeks’ gestation who at 33 to 35 weeks’ postmenstrual age were receiving caffeine treatment with plans to discontinue it plus receiving full feeds (≥120 mL/kg/d). Follow-up was completed on March 20, 2023.

INTERVENTIONS: Infants were randomized to oral caffeine citrate (10 mg/kg/d) or placebo until 28 days after discharge.

MAIN OUTCOMES AND MEASURES: The primary outcome was days to discharge after randomization. Secondary outcomes included days to physiological maturity (apnea free for 5 consecutive days, receiving full oral feeds, and out of the incubator for at least 48 hours), postmenstrual age at discharge, all-cause hospital readmissions, all-cause sick and emergency department visits, safety outcomes, and death.

RESULTS: A total of 827 infants (median gestational age, 31 weeks; 414 female [51%]) were randomized (416, caffeine; 411, placebo) out of the 878 planned before reaching the prespecified futility threshold. Days of hospitalization after randomization did not differ between groups (18.0 days [IQR, 10 to 30 days] for caffeine vs 16.5 [IQR, 10 to 27 days] for placebo; adjusted median difference, 0 days [95% CI, -1.7 to 1.7 days]), nor did days to physiological maturity differ (14.0 vs 15.0 days, adjusted median difference, -1 day [95% CI, -2.4 to 0.4 days]). Infants receiving caffeine were apnea free sooner (6.0 vs 10.0 days; adjusted median difference, -2.7 days [95% CI, -3.4 to -2.0 days ]) but had similar days to full oral feeding (7.5 vs 6.0 days, adjusted median difference, 0 days [95% CI, -0.1 to 0.1]). Rates of readmissions and sick visits did not differ between groups. There was no statistically significant difference in adverse events between the 2 groups.

CONCLUSIONS AND RELEVANCE: In moderately preterm infants, continuation of caffeine treatment compared with placebo did not shorten hospitalization.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03340727.

PMID:40294395 | DOI:10.1001/jama.2025.5791