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Importance:The management of patent ductus arteriosus (PDA) in preterm infants is controversial. Objective:To determine whether expectant management compared with active treatment of a protocol-defined PDA in preterm infants decreases the incidence of death or bronchopulmonary dysplasia (BPD). Design, Setting, and Participants:A randomized clinical trial including infants born at 22 to 28 weeks' gestation and diagnosed with a protocol-defined PDA between the age of 48 hours and 21 days at screening. The trial was conducted from December 2018 to December 2024 at 33 hospitals within the National Institute of Child Health and Human Development Neonatal Research Network. The final date of follow-up was June 2025. Interventions:Infants with PDA were randomized to expectant management (n = 242) or active treatment (n = 240; acetaminophen, ibuprofen, or indomethacin) to close the PDA. Main Outcomes and Measures:The primary outcome was death or BPD at 36 weeks' postmenstrual age. The secondary outcomes included the components of the primary outcome and other morbidities of prematurity. Results:A total of 482 infants were randomized (median gestational age, 25 weeks [IQR, 24 to 27 weeks]; median birth weight, 760 g [IQR, 620 to 935 g]). The trial was stopped for futility and safety after the 50% interim analysis for the primary outcome due to higher survival in the expectant management group. The incidence of death or BPD was 80.9% (195/241) of infants in the expectant management group vs 79.6% (191/240) of infants in the active treatment group (adjusted risk difference, 1.2% [95% CI, -5.7% to 8.1%]; P = .73). The incidence of death before 36 weeks' postmenstrual age was 4.1% (10/241) of infants in the expectant management group vs 9.6% (23/240) of infants in the active treatment group (adjusted risk difference, -5.6% [95% CI, -10.1% to -1.2%]; P = .01). Infections resulting in death occurred in 0.8% (2/241) of infants in the expectant management group vs 3.8% (9/240) of infants in the active treatment group. Conclusions and Relevance:In extremely preterm infants with a protocol-defined PDA, death or BPD did not differ between the expectant management group and the active treatment group. Survival was substantially higher with expectant management. Trial Registration:ClinicalTrials.gov Identifier: NCT03456336.
RATIONALE:Bronchoscopic lung volume reduction (BLVR) is an established treatment option for severe emphysema, improving lung function and quality of life. Despite its growing use, there are no standardized, validated tools to assess operator competency in performing BLVR, limiting training and credentialing. OBJECTIVE:To examine the validity of the VSTAT tools, which were designed to assess competency in cognitive and technical skills necessary for BLVR. METHODS:The Zephyr and Spiration VSTAT tools were used to assess 29 operators with varying levels of experience. Participants were categorized as Beginners, Intermediates, and Experts. Performance was evaluated through simulated scenarios. Scores were analyzed for reliability, validity, and correlation with clinical experience. RESULTS:The tools demonstrated strong internal consistency (Cronbach α=0.88 for Zephyr and 0.77 for Spiration). Significant differences in scores were observed across proficiency levels, with experts outperforming beginners. VSTAT scores correlated strongly with procedural experience (Spearman ρ=0.95 for Zephyr, ρ=0.70 for Spiration). CONCLUSION:The VSTAT tools provide a reliable and valid method for assessing BLVR competency. Their integration into training programs and certification processes could standardize the assessment of operator competency in BLVR.
Cervical disc arthroplasty (CDA) is a well-established motion-preserving treatment for cervical degenerative disc disease. The Bryan® Cervical Disc is among the most widely used implants with supportive long-term outcome data; however, late implant migration is a rare occurrence and can result in significant neurologic compromise. A female in her mid-50s with a history of C5-6 Bryan Cervical Disc arthroplasty performed 20 years prior presented with progressive cervical myelopathy. She reported a fall from a horse two years before evaluation. Neurologic examination demonstrated bilateral upper-extremity weakness distal to the C5-6 motor distribution, hyperreflexia, and positive bilateral Hoffmann sign, Spurling test, and Lhermitte's sign without clonus. Cervical radiographs with flexion-extension views demonstrated posterior migration of the C5-6 prosthesis, concerning for canal encroachment. The patient underwent removal of the arthroplasty device with C5-6 anterior cervical fusion, resulting in successful decompression and clinical improvement. Very late posterior migration of a Bryan Cervical Disc arthroplasty can present decades after implantation and may cause progressive cervical myelopathy. New or worsening myelopathic findings in patients with prior cervical disc replacement should prompt urgent evaluation for delayed mechanical failure, including implant migration. Implant removal and conversion to fusion can provide definitive decompression and stabilization with favorable outcomes.
Optimal cephalexin and cefadroxil dosing for skin and soft tissue infections (SSTIs) is unclear. We summarize clinical and pharmacokinetic/pharmacodynamic (PK/PD) data that compare dosing strategies for SSTIs. Additionally, we conduct population PK target attainment simulations for varying doses of cephalexin and cefadroxil for Staphylococcus aureus and Group A Streptococcus. Although some clinical data support lower doses in mild SSTIs, higher doses optimize PK/PD parameters in moderate-severe SSTIs, especially due to Staphylococcus aureus. Further prospective clinical and PK/PD studies, especially in obese adults, would be beneficial.
