JAMA Network Open最新文献

Importance: Preterm infants are at high risk of developing brain injury, and near-infrared spectroscopy (NIRS) offers the ability to measure cerebral oxygenation. The impact of using a standardized treatment guideline combined with a single NIRS device manufacturer (Nonin Medical Inc) and neonatal sensor on cerebral oxygenation has not been previously examined.

Objective: To investigate whether cerebral oximetry with a dedicated treatment guideline improves cerebral oxygenation stability.

Design, setting, and participants: This was a single-blinded, 2-arm randomized clinical trial conducted from October 2021 to July 2024 at 5 tertiary neonatal intensive care units across Australia, New Zealand, and the US. Infants born at less than 29 weeks' gestation and aged younger than 6 hours underwent 1:1 random allocation stratified by gestational age (<26 weeks and ≥26 weeks) and study site.

Intervention: The intervention group received cerebral oximetry and dedicated guideline-based treatment when cerebral oxygenation was outside the range of 65% to 90%. The control group had blinded cerebral oximetry and treatment guided by standard clinical monitoring.

Main outcomes and measures: The burden of cerebral hypoxia and hyperoxia during the first 5 days after birth expressed as percentage hours was the primary outcome. Key secondary outcomes were mortality, morbidities before discharge, and NIRS-related skin injury.

Results: Of 149 screened infants (53 randomized to the intervention and 51 randomized to standard care), 100 infants were included in the final analysis (median [IQR] gestational age, 27 [25-28] weeks; 48 male [48.0%]). The median (IQR) birth weight was 883 (709-1079) g. The intervention group (50 infants) had a significantly lower median (IQR) burden of hypoxia and hyperoxia of 5.7% hours (2.8% hours to 15.0% hours) compared with 39.6% hours (6.5% hours to 82.3% hours) in the standard care group (50 infants), with an adjusted reduction of 42.8% hours (95% CI, 35.6% hours to 53.3% hours; P < .001). Mortality, morbidities before discharge, and safety outcomes were comparable between groups.

Conclusions and relevance: In this study, treatment guided by cerebral oximetry with a single device manufacturer and a neonatal sensor significantly improved the stability of cerebral oxygenation in extremely preterm infants. Larger multicenter trials are warranted to determine if this finding leads to improved survival without brain injury.

Trial registration: Australian New Zealand Clinical Trials Registry registration number ACTRN12621000778886.

Importance: Prostate cancer incidence is projected to double by 2040, yet optimal risk stratification approaches for screening remain unclear despite recent international endorsements of organized programs that call for risk-adapted algorithms using readily available biomarkers.

Objective: To identify biomarkers for risk-adapted prostate cancer screening in men without prostate cancer.

Design, setting, and participants: This cohort study used data from the Study of Health in Pomerania (SHIP), a prospective population-based research initiative in Germany that randomly invited participants aged 20 to 79 years who underwent comprehensive examinations with structured 20-year follow-up. Data were collected from October 17, 1997, through September 14, 2021, with final analysis completed November 16, 2025.

Exposures: Baseline clinical and liquid biomarkers, including body mass index, waist-to-hip ratio, and glycated hemoglobin, together with prostate cancer-specific biomarkers of serum prostate-specific antigen (PSA) and magnetic resonance imaging-derived prostate volume and PSA density.

Main outcomes and measures: The primary outcome was long-term prostate cancer incidence. Cumulative incidence functions for prostate cancer and death were treated as competing risks. Cause-specific Cox models were used to estimate risk and assess the association between baseline biomarkers and long-term incidence.

Results: Among 2651 men included in the study (median [IQR] age, 54.0 [48.0-62.0] years), 1482 (55.9%) had low baseline PSA levels (<1.00 ng/mL), with a cumulative prostate cancer incidence of 0.1% (95% CI, 0.0%-0.4%), 0.6% (95% CI, 0.3%-1.2%), and 3.3% (95% CI, 2.1%-4.8%) at 5, 10, and 20 years, respectively. In 958 men (36.1%) with intermediate PSA levels (1.00-3.00 ng/mL), prostate cancer incidence was 1.4% (95% CI, 0.7%-2.3%), 5.0% (95% CI, 3.6%-6.6%), and 11.8% (95% CI, 9.2%-14.8%) at 5, 10, and 20 years, respectively. In 211 men (8.0%) with high PSA levels (>3.00 ng/mL), prostate cancer incidence was 14.5% (95% CI, 10.1%-19.7%), 28.3% (95% CI, 22.2%-34.8%), and 34.8% (95% CI, 27.5%-42.2%) at 5, 10, and 20 years, respectively. Cumulative prostate cancer incidence differed significantly among the PSA groups (P < .001). In univariable and multivariable Cox regression, age (hazard ratio [HR], 1.04; 95% CI, 1.02-1.07), PSA (HR, 1.06; 95% CI, 1.04-1.07), and PSA density (HR, 1.41; 95% CI, 1.30-1.52) remained consistently associated with prostate cancer risk, whereas other variables showed either no association or inconsistent results across models.

Conclusions and relevance: This cohort study found that a low baseline PSA level was associated with low long-term prostate cancer risk among men aged 45 to 70 years, supporting risk-adapted screening with extended intervals for men with low PSA levels.