Lubiprostone Study: Ineffective for Pediatric Functional Constipation

MA Benninga et al. DOI:https://doi.org/10.1016/j.cgh.2021.04.005 Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-blind Study With Long-term Extension

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).

Related blog posts:

Normative Data for Fecal Calprotectin, age 4-16 yrs

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.

Related blog posts:

AAP Behind the Scenes (Fall 2020)

This Georgia AAP (virtual) board meeting started with a brief review from Dr. Kathleen Tomey (Department of Health)

Some slides:

This data should be interpreted based on limited testing in this age group

AAP Update from Dr. Scornik:

Toolkit available at Georgia AAP Website
Full link: Race, Postoperative Complications, and Death in Apparently Healthy Children
Link to register: Fall AAP Meeting

Safe sleep initiatives briefly discussed by Dr. Sarah Lazarus which aligns with Strong4Life campaign:

From Dr. Evan Anderson’s presentation to AAP Board Meeting
Dr. Anderson notes that COVID-19 mortality and morbidity IN CHILDREN exceeding other conditions with vaccines like Varicella and Influenza.
Letter from AAP President to FDA (Dr. Hahn) and HHS (Alex Azar)

Other information:

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

Disclaimer: This blog, gutsandgrowth, assumes no responsibility for any use or operation of any method, product, instruction, concept or idea contained in the material herein or for any injury or damage to persons or property (whether products liability, negligence or otherwise) resulting from such use or operation. These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) should be confirmed by prescribing physician.  Because of rapid advances in the medical sciences, the gutsandgrowth blog cautions that independent verification should be made of diagnosis and drug dosages. The reader is solely responsible for the conduct of any suggested test or procedure.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition

COVID-19 Toll on U.S. Children

From AAP News: AAP Report: 513,415 children diagnosed with COVID-19

  • 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.
  • There have been 792 confirmed cases of multisystem inflammatory syndrome in children in 42 states, New York City and Washington, D.C., and 16 death

Online Aspen Webinar (Part 2) -Abnormal Liver Enzymes in a Tween

What Do Abnormal Liver Enzymes Mean in a Tween William Balistreri

Below I’ve included a few slides and some notes; my notes may have errors of omission or transcription.

Key Points:

  • Provided updated normal reference data for ALT/AST along with patterns of abnormalities
  • Reviewed step-wise workup for teenagers with elevated ALT/AST, particularly fatty liver disease and drug-induced liver disease
  • Increasingly frequent cause of fatty liver disease: psychotropic medications
  • Discussed role/indications of liver biopsy. Liver biopsy is NOT practical option for all children with fatty liver disease and elevated liver enzymes
  • However, ALT values tend to underestimate severity of liver disease

 

 

COVID-19 in Children from Italy

NEJM: Children with Covid-19 in Pediatric Emergency Departments in Italy

Key points:

  • Children younger than 18 years of age who had Covid-19 composed only 1% of the total number of patients; 11% of these children were hospitalized, and none died
  • The Coronavirus Infection in Pediatric Emergency Departments (CONFIDENCE) study involved a cohort of 100 Italian children younger than 18 years of age with Covid-19 (median age 3.3 years)
    • .Common symptoms were cough (in 44% of the patients) and no feeding or difficulty feeding (in 23%) (especially if <2 years)
    •  Fever, cough, or shortness of breath occurred in 28 of 54 of febrile patients (52%)
    •  Of the 9 patients who received respiratory support, 6 had coexisting conditions

My take: This study provides additional data indicating that severe outcomes are rare in children with Covid-19.

Related article from NY Times: How Coronavirus Mutates and Spreads

An excerpt:

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.

Related blog posts:

Improving Obesity Trend in Young Children?

Link (YouTube): William Meyers Inaugural Conference Lecture

Related blog post: William Meyers

———————————

CBS News: Study shows declining obesity rate for preschoolers who receive government food aid

An excerpt:

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.

Related blog posts:

Ledipasvir-Sofosbuvir for Children 6-11 years

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.

Key findings:

  • 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.

Related blog posts:

Mesquite Flat Sand Dunes, Death Valley

More on Hepatitis B Treatment in Children

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.”

Mina Falls, El Yunque Rainforest

Mina Falls, El Yunque Rainforest