Drying Very Preterm Infants Before Plastic Wrapping at Birth: A Randomized Clinical Trial
1. Drying before plastic wrapping did not benefit very preterm infants in maintaining normothermia at admission to the neonatal intensive care unit.
Evidence Rating Level: 1 (Excellent)
Hypothermia at birth is linked with adverse neonatal outcomes. Despite the existence of interventions to prevent thermal loss at birth in very preterm infants, the incidence of hypothermia among this population at admission to the neonatal intensive care unit (NICU) remains high. Very preterm infants are commonly put in plastic wrap immediately at birth without drying to prevent heat loss. For infants of gestational age >32 weeks, drying has been recommended for thermal management. The potential advantages of combining drying and wrapping have not been explored for very preterm infants, who are at higher risk of heat loss due to evaporation. This study thus examined whether drying before plastic wrapping improves thermoregulation of very preterm infants at birth. This multicenter randomized clinical trial was conducted at 21 hospitals in Italy between February 21, 2023, and July 18, 2024, and included very preterm infants (birth weight <1500 g and/or gestational age ≤30 weeks 6 days). Neonates were randomly assigned 1:1 to either drying before plastic wrapping in the delivery room (intervention arm) or plastic wrapping without drying (control arm). The primary outcome was the proportion of infants within the normal thermal range (normothermia; 36.5-37.5 °C) at admission to the NICU. In total, 354 very preterm infants were randomized and included in the analysis (180 females [50.8%]; mean [SD] gestational age, 28.6 [2.5] weeks), with 177 in the intervention arm and 177 in the control arm. The proportion of neonates with normothermia was not significantly different between those dried vs undried (45.8% (81/177) vs 46.3% (82/177); risk ratio [RR], 0.99; 95% CI, 0.79-1.24). Dried neonates experienced a higher rate of in-hospital mortality compared to undried neonates (14.7% [26/177] vs 5.6% [10/177]; unadjusted risk ratio, 2.60; 95% CI, 1.29-5.23). Overall, this study found that drying before plastic wrapping did not benefit very preterm infants in maintaining normothermia at NICU admission. These results do not support drying before wrapping in the thermal management of this population.
1. Maternal smoking behaviour increased the risk of Sudden Unexpected Infant Death, with the highest risk among those who continuously smoked during pregnancy.
Evidence Rating Level: 2 (Good)
Sudden Unexpected Infant Death (SUID) involves sleep-related deaths during infancy that are due to sudden infant death syndrome, accidental suffocation or strangulation in bed, and other unknown causes. While maternal smoking during pregnancy is an important risk factor for SUID, the impact of variations in smoking behaviours (e.g. timing, intensity, and cessation) is unclear. This study thus examined the association between maternal smoking and SUID, while incorporating categorizations of smoking behaviours. This retrospective cohort study using data from the Centre for Disease Control Linked Birth-Infant Death files included singleton live births (birth weight >1000 g, gestational age >25 weeks) in the US occurring between January 1, 2017, and December 31, 2021, and infant deaths within the first year of life. The primary exposure was maternal smoking behaviour, categorized into non-smoking, pre-pregnancy smoking only, trimester-specific smoking, continuous or discontinuous smoking, and cessation before the third trimester, with stratification by smoking intensity (heavy vs light smoker). This study included 16,484,245 live births. In total, 15,222,196 (92%) patients were non-smokers, 664,741 (4%) were heavy smokers who continuously smoked during their pregnancy, 234,259 (1.4%) were heavy smokers who only smoked during pre-pregnancy, and 154,618 (0.94%) were heavy smokers who ceased smoking before their third trimester. After adjusting for socio-economic disparities and key pregnancy and infant factors, heavy continuous smokers had the highest odds for SUID (aOR 2.81, 95% CI 2.67–2.94), followed by light continuous smokers (aOR 2.47, 95% CI 2.19–2.78) and discontinuous heavy smokers (aOR 2.29, 95% CI 1.72–3.00) compared with non-smokers. Pre-pregnancy-only smokers had the lowest odds of SUID among all smoking categories (light smoker: aOR 1.77, 95% CI 1.48–2.10; heavy smoker: aOR 1.61, 95% CI 1.44–1.78). There were no differences found between heavy and light smokers for any category. Overall, this study found that maternal smoking behaviour increased the risk of SUID, with the highest risk among those who continuously smoked during pregnancy. Future research should examine other substance use and their potential interactions with smoking to understand the combined effects.
1. Telemedicine was non-inferior to conventional care in reducing pain and improving function for patients with RCS.
Evidence Rating Level: 1 (Excellent)
Exercise programs can effectively reduce pain and improve shoulder function in Rotator Cuff Syndrome (RCS). Telemedicine involving asynchronous exercise video and remote physician follow-up can provide advantages in accessibility and cost-effectiveness and has emerged as a promising alternative to traditional in-person rehabilitation. This study thus evaluated the effectiveness of telemedicine compared to conventional methods in the rehabilitation of RCS. This randomized controlled trial was conducted at a public hospital physiatry clinic between November 2023 and June 2024 and included adults aged 30-64 with magnetic resonance imaging (MRI)-confirmed unilateral rotator cuff tendinopathy (tendinitis/ tendinosis), impingement, or partial rupture. Participants were randomized 1:1 to the telemedicine group or the control group. The telemedicine group received asynchronous exercise videos and remote video-call follow-ups, while the control group received illustrated exercise brochures and in-person follow-ups. Outcomes were assessed at baseline, 15th day, and 6th month. The primary outcomes were pain measured using the Visual Analog Scale (VAS) (0 = no pain, 10 = worst pain) and functional recovery assessed using the Quick Disabilities of Arm, Shoulder, and Hand (QuickDASH) (0 = no disability, 100 = most severe disability). Out of the 90 patients randomized (mean age, 51.19 ± 7.07 years; 54 females [60%]), 81 patients completed the study, with 43 in the telemedicine group and 38 in the control group. Both the telemedicine and control group showed within-group improvements in VAS (mean change −1.88 [95% CI −2.56 to −1.20]) and QuickDASH (−15.6 [95% CI −21.0 to −10.2]) scores from baseline to 15th day and in VAS from baseline to 6th month (−4.82 [95% CI −5.50 to −4.13]). Between the two groups, there were no differences found in pain reduction at 15th day (estimate = −0.27, 95% CI −1.44 to 0.89) or at 6th month (estimate = −0.40, 95% CI −1.57 to 0.77), nor in functional improvement at 15th day (estimate = −2.68, 95% CI −12.90 to 7.57). No clinically meaningful difference in pain or functional outcomes was found between the groups at either follow-up point. Overall, this study found that telemedicine was non-inferior to conventional in-person care in reducing pain and improving function for patients with RCS, highlighting its potential as an alternative for traditional rehabilitation for this population.
Statins and postmenopausal breast cancer risk; results from the KARMA cohort
1. Statin use did not increase the risk of developing breast cancer among postmenopausal women.
Evidence Rating Level: 2 (Good)
While statins are commonly used lipid-lowering drugs in the prevention of cardiovascular disease, they may also play a role in preventing breast cancer, although the evidence is conflicting. This study thus investigated statin use and the risk of incident breast cancer as well as the subtype of breast cancer, in postmenopausal women. The Karolinska Mammography Project for Risk Prediction of Breast Cancer (KARMA) was a prospective cohort study that included postmenopausal women undergoing clinical or screening mammography from four hospitals between January 2011 and March 2013. Participants were followed until the date of invasive breast cancer diagnosis, date of death, or December 31, 2019, whichever came first. In total, 35,315 participants were included in the study (median age [IQR], 62 [57, 67]). The median follow-up time was 6.6 years. In total, 25% of participants were statin users, of which 16% were prevalent statin users, and 9% were incident statin users. During eight years of follow-up, there were 785 incident invasive breast cancer cases reported. Incident or prevalent statin use was not significantly associated with risk of incident breast cancer (Adjusted hazard ratio [HRadj] 1.24, 95% CI 0.89–1.72, and HRadj 0.90, 95% CI 0.73–1.11, respectively). Incident or prevalent statin use was also not significantly associated with subtype-specific risk of breast cancer. Overall, this study found statin use did not increase the risk of developing breast cancer among postmenopausal women, suggesting statins are safe medications in the context of breast cancer for this population. Future studies with longer follow-up are needed to confirm the study findings.
Apolipoprotein E Mimetic Peptide CN-105 and Postoperative Delirium in Older Patients
1. Apolipoprotein E Mimetic Peptide CN-105 was found to be safe and feasible among older patients with noncardiac or nonintracranial surgery.
Evidence Rating Level: 1 (Excellent)
Apolipoprotein E (APOE) gene ε4 allele is linked with neuroinflammation and is a potential risk factor for postoperative delirium. ApoE and apoE mimetic peptides, such as CN-105 may reduce delirium incidence by blocking neuroinflammation. CN-105 has been found to be safe and tolerable among healthy participants in two previous phase 1 MARBLE (Modulating ApoE Signaling to Reduce Brain Inflammation, Delirium, and Postoperative Cognitive Dysfunction) trials. This phase 2 MARBLE trial thus examined the safety and feasibility of CN-105 for reducing postoperative delirium and neuroinflammation in older surgical patients. This randomized clinical trial enrolled patients from April 17, 2019, to December 28, 2022, at a tertiary academic medical center in North Carolina, U.S., and included patients > 60 years older scheduled for a noncardiac or nonintracranial surgery. Patients were randomly assigned 3:1 to the CN-105 group or placebo group. The CN-105 group received intravenous CN-105 doses of 0.1, 0.5, or 1 mg/kg (3 cohorts). The primary outcome was the incidence and number of postoperative adverse events (AEs) at 6 weeks. In total, 186 participants were randomized and underwent surgery (mean [SD] age, 68.7 [5.2] years; 119 males [64.0%]), with 137 in the CN-105 group and 49 in the placebo group. The rates of grade 2 or higher AEs among patients between the CN-105 vs placebo groups were not significantly different (76.6% vs 87.8%; relative risk [RR], 0.87; 95% CI, 0.76-1.00). The CN-105 group had fewer grade 2 or higher AEs per patient compared to the placebo group (median [IQR], 1 [1-3] vs 2 [1-5]). The percentage of CN-105 doses administered within the time window was 94.6% (860/ 909; 95% CI, 92.9%-96.0%) in the CN-105 group and 93.8% (346/369; 95% CI, 90.8%-96.0%) in the placebo group, exceeding the prespecified feasibility threshold of >90%. Overall, this phase 2 trial found CN-105 to be safe and feasible among older patients with noncardiac or nonintracranial surgery. Future trials are needed to evaluate the efficacy of CN-105 for reducing postoperative AEs.
Image: PD
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