Key finding: 606 patients were randomized to treatment (placebo: n=202; lubiprostone: n=404). No statistically significant difference in overall SBM (spontaneous bowel movement) response rate was observed between the lubiprostone and placebo groups (18.5% vs 14.4%; P=.2245).
This study collected prospective data from 212 children. Key finding: The median and 95th percentile for fCP were 18.8 mg/kg and 104.5 mg/kg, respectively. “We found a statistically significant association between the 95th percentile of fCP concentrations and age (p < 0.001).”
My take: This is another study showing that calprotectin cut off values need to be higher in younger children.
This Georgia AAP (virtual) board meeting started with a brief review from Dr. Kathleen Tomey (Department of Health)
AAP Update from Dr. Scornik:
Safe sleep initiatives briefly discussed by Dr. Sarah Lazarus which aligns with Strong4Life campaign:
Update on E-Cigarettes Webinar*+: Wednesday, October 28 at 12:30 pm Please note new date! Here’s a chance to still register. First in a series of three webinars offered to Georgia Pediatricians on the growing epidemic of youth e-cigarette use Faculty: Alice Little Caldwell, MD, FAAP https://register.gotowebinar.com/register/8457518617359610381
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The latest report shows a rate of 680 COVID-19 cases per 100,000 children.
Children make up 9.8% of the total cases and about 1.7% of all COVID-19 hospitalizations, up from 0.8% of hospitalizations in late May.
Roughly 1.9% of children diagnosed with COVID-19 have been hospitalized, according to data from the 23 states and New York City that are publicly reporting hospitalization data.
There also have been at least 103 pediatric deaths in 42 states and New York City, making up about 0.07% of all COVID-19 deaths. Roughly 0.02% of children who have contracted known cases of COVID-19 have died.
Researchers have found that the coronavirus is mutating relatively slowly compared to some other RNA viruses, in part because virus proteins acting as proofreaders are able to fix some mistakes. Each month, a lineage of coronaviruses might acquire only two single-letter mutations.
In the future, the coronavirus may pick up some mutations that help it evade our immune systems. But the slow mutation rate of the coronavirus means that these changes will emerge over the course of years.
That bodes well for vaccines currently in development for Covid-19. If people get vaccinated in 2021 against the new coronavirus, they may well enjoy a protection that lasts for years.
The obesity rate for preschoolers who receive government food aid has declined, according to a study released Tuesday in the Journal of the American Medical Association. Obesity rates dropped steadily to about 14% in 2016 — the latest data available — from 16% in 2010, the Centers for Disease Control and Prevention reported.
The improvement affected youngsters ages 2 through 4 who receive food vouchers and other services in the federal Women, Infants and Children nutrition program. About 1 in 5 U.S. kids that age were enrolled in 2016…
My take: This is good news. Hopefully, this report will be one of many indicating that the rates of obesity could actually improve.
Almost two years ago, the FDA approved Ledipasvir-Sofosbuvir (aka Harvoni) for pediatric patients 12-17 years of age with hepatitis C virus (HCV) infection. Now, a recent study (KF Murray, WF Balistreri, S Bansal et al. Hepatology 2018; 68: 2158-66) is likely to expedite approval for children ages 6-11 years of age.
In this open-label study with 92 patients, 88 had genotype 1, 89 received treatment with ledipasvir-sofosbuvir without ribavirin for 12 weeks, 97% were perinatally-infected, and 78% were treatment naive. The median age was 9 years. The dose (determined by intense pharmacokinetics) was 45 mg-200 mg (half the adult dosage). Two patients with genotype 3 HCV received ledipasvir-sofosbuvir for 24 weeks along with ribavirin.
SVR12 was 99% (91/91). The single patient without SVR12 had relapsed 4 weeks after completing a 12 week treatment course.
Ledipasvir-sofosbuvir was well-tolerated; the common adverse events reported were headache and pyrexia.
The authors note that while most children are considered to have mild symptoms or are asymptomatic, some progress to have significant fibrosis or cirrhosis, a small minority develop hepatocellular carcinoma, and HCV infection can impact both cognitive development and overall health.
My take: This study confirms that effectiveness of DAA therapy with ledipasvir/sofosbuvir in children as young as 6 years of age.
Related study: F Tucci et al. Hepatology 2018; 68: 2434-37. The authors report the successful treatment with ledipasvir/sofosbuvir of an infant with both SCID and HCV infection.
A recent post (New Hepatitis B Treatment Guidelines -AASLD) described the updated treatment recommendations. When these guidelines were published, a separate review devoted specifically to pediatrics was published (Hepatology 2016; 63: 307-18).
Some of the key points:
This pediatric review included 14 studies with 1425 children. The authors note that 7 of these trials had a high risk of bias. Also, the studies are limited by relying on surrogate markers of long-term outcomes as clinical outcomes like cirrhosis, HCC, and death are rare in childhood.
Among oral agents, entecavir and lamivudine are approved for use in children ≥ 2 years, whereas adefovir and tenofovir are approved for use in children ≥ 12 years. Both lamivudine and adefovir are associated with frequent development of viral resistance
For children with elevated ALT (>1.5 times upper limit of normal [ULN]), treatment is recommended:
9A. The AASLD suggests antiviral therapy in HBeAg-positive children (ages 2 to <18 years) with both elevated ALT and measurable HBV DNA levels, with the goal of achieving sustained HBeAg seroconversion.
Why not treat everyone?
Children with immune-tolerant HBV infection (normal or near-normal ALT [< 1.5-2 times ULN] along with high HBV DNA [>10 million IU/mL]), “are not typically candidates for treatment because treatment with any of the currently available drugs has not been demonstrated to improve HBeAg seroconversion compared with no treatment.”
Children with ALT >10 time ULN may be in the process of spontaneous seroconversion “and should be observed for several months before treatment” is initiated.
“Prolonged treatment with nucleoside or nucleotide analogs in children who are in immune-tolerant phase has not been associated with substantial benefit and carries a risk of developing antiviral drug resistance…An exception may be those…undergoing immunosuppressive therapy.”