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Electronic Nicotine Delivery Systems (ENDS)

Electronic nicotine delivery systems (ENDS), also called electronic cigarettes, e-cigarettes, vaping devices, or vape pens, are battery-powered devices used to smoke or “vape” a flavored solution which usually contains nicotine. The American Academy of Family Physicians (AAFP) recognizes the alarmingly increased use of ENDS, especially among youth and young adults, as well as its use by those attempting to quit smoking tobacco.

The AAFP calls for further research to assess ENDS’ safety, quality, and efficacy as a potential cessation device. The AAFP also recommends that the marketing and advertising of ENDS to children and youth cease immediately. The AAFP encourages members to screen for ENDS use starting with school-age children, to discuss the potential harms of ENDS, and to recommend cessation interventions with e-cigarette users. The AAFP encourages members to inform patients who use ENDS, especially children, that the majority of these products contain nicotine and are addictive.  (2014 COD) (April 2019 BOD)

Keywords 
adolescent adult child nicotine tobacco vaping family electronic protocol U.S.

Concussion Incidence, Duration, and Return to School and Sport in 5- to 14-Year-Old American Football Athletes

Author/s: 
Chrisman, Sara P. D., Lowry, Sara, Herring, Stanley A., Kroshus, Emily, Hoopes, Teah R., Higgins, Shannon K., Rivara, Frederick P.

OBJECTIVE:

To collect prospective data on concussion incidence, risk factors, duration of symptoms, and return to school and sport in 5- to 14-year-old American football participants.

STUDY DESIGN:

We conducted a prospective cohort study over 2 years collecting data during two 10-week fall seasons. Youth with concussion were followed to determine time to return to school, sport, and baseline level of symptoms. Logistic regression was used to estimate the risk of sustaining a concussion associated with baseline demographic factors. Time to return to school, sport, and baseline symptoms were analyzed using Kaplan-Meier survival curves.

RESULTS:

Of 863 youth followed (996 player-seasons), 51 sustained a football-related concussion, for an athlete-level incidence of 5.1% per season. Youth with history of concussion had a 2-fold increased risk for sustaining an incident concussion (OR, 2.2; 95% CI, 1.1-4.8). Youth with depression had a 5-fold increased risk of concussion (OR, 5.6; 95% CI, 1.7-18.8). After a concussion, 50% of athletes returned to school by 3 days, 50% returned to sport by 13 days, and 50% returned to a baseline level of symptoms by 3 weeks.

CONCLUSIONS:

Concussion rates in this study were slightly higher than previously reported, with 5 of every 100 youth sustaining a football-related concussion each season. One-half of youth were still symptomatic 3 weeks after injury. Further research is needed to address the risk of concussion in youth football.

Keywords 
child brain trauma

Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents

Author/s: 
Hayden, Frederick G., Sugaya, Norio, Hirotsu, Nobuo, Lee, Nelson, de Jong, Menno D., Hurt, Aeron C., Ishida, Tadashi, Sekino, Hisakuni, Yamada, Kota, Portsmouth, Simon, Kawaguchi, Keiko, Shishido, Takao, Arai, Masatsugu, Tsuchiya, Kenji, Uehara, Takeki, Watanabe, Akira, Baloxavir Marboxil Investigators Group

BACKGROUND:

Baloxavir marboxil is a selective inhibitor of influenza cap-dependent endonuclease. It has shown therapeutic activity in preclinical models of influenza A and B virus infections, including strains resistant to current antiviral agents.

METHODS:

We conducted two randomized, double-blind, controlled trials involving otherwise healthy outpatients with acute uncomplicated influenza. After a dose-ranging (10 to 40 mg) placebo-controlled trial, we undertook a placebo- and oseltamivir-controlled trial of single, weight-based doses of baloxavir (40 or 80 mg) in patients 12 to 64 years of age during the 2016-2017 season. The dose of oseltamivir was 75 mg twice daily for 5 days. The primary efficacy end point was the time to alleviation of influenza symptoms in the intention-to-treat infected population.

RESULTS:

In the phase 2 trial, the median time to alleviation of influenza symptoms was 23.4 to 28.2 hours shorter in the baloxavir groups than in the placebo group (P<0.05). In the phase 3 trial, the intention-to-treat infected population included 1064 patients; 84.8 to 88.1% of patients in each group had influenza A(H3N2) infection. The median time to alleviation of symptoms was 53.7 hours (95% confidence interval [CI], 49.5 to 58.5) with baloxavir, as compared with 80.2 hours (95% CI, 72.6 to 87.1) with placebo (P<0.001). The time to alleviation of symptoms was similar with baloxavir and oseltamivir. Baloxavir was associated with greater reductions in viral load 1 day after initiation of the regimen than placebo or oseltamivir. Adverse events were reported in 20.7% of baloxavir recipients, 24.6% of placebo recipients, and 24.8% of oseltamivir recipients. The emergence of polymerase acidic protein variants with I38T/M/F substitutions conferring reduced susceptibility to baloxavir occurred in 2.2% and 9.7% of baloxavir recipients in the phase 2 trial and phase 3 trial, respectively.

CONCLUSIONS:

Single-dose baloxavir was without evident safety concerns, was superior to placebo in alleviating influenza symptoms, and was superior to both oseltamivir and placebo in reducing the viral load 1 day after initiation of the trial regimen in patients with uncomplicated influenza. Evidence for the development of decreased susceptibility to baloxavir after treatment was also observed. (Funded by Shionogi; JapicCTI number, 153090, and CAPSTONE-1 ClinicalTrials.gov number, NCT02954354 .).

Keywords 
baloxavir marboxil oseltamivir influenza
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