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Meet the Editors

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

Articles

Kay Rhee, MD, discusses the challenges of pediatric obesity treatment, highlighting the role of biological and environmental factors, behavioral interventions, and the potential benefits of GLP-1 medications in weight management for children and teens.


Overcoming pediatric obesity: Behavioral strategies and GLP-1 support

. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

At the 2024 AAP National Conference, Steven Selbst, MD, highlighted the rise in accidental THC ingestions among children, urging pediatricians to counsel parents on the dangers of improperly stored THC gummies that resemble candy.

Trend talk: Increasing THC ingestions in pediatric emergency departments

Angela Chun, MEd, MD, FAAP, shares tips on distinguishing mechanical vs inflammatory joint pain in children, emphasizing timing, activity, and key physical exam maneuvers.

Angela Chun, MEd, MD, FAAP, identifies red flags in pediatric joint pain

A single dose of the mRNA-1273.222 vaccine demonstrated strong immune responses against various omicron subvariants and showed a favorable safety profile compared to existing vaccines. 

 Phase 2/3 trial of new omicron-targeted vaccine shows efficacy in adolescents

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Dr Still is a pediatric resident, University of Nevada School of Medicine, Las Vegas.

Influenza Vaccine Live (FluMist; AstraZeneca) is now FDA approved for the prevention of

caused by subtypes A and B for self- or caregiver-administration among individuals aged 2 to 49 years, according to an announcement from the federal agency.

Initially approved for use in 2003 for individuals aged 5 to 49 years, the FDA approved use of the nasal vaccine in children as young as 2 years of age in 2007. 

FluMist, which still requires a prescription, contains a weakened form of live influenza virus strains that are sprayed in the nose. With the updated indication, the vaccine may be administered by a health care provider in a health care setting (including a pharmacy) or it may be administered by the vaccine recipient or a caregiver who is 18 years of age or older, the FDA stated.

Tina Tan, MD, FAAP, FIDSA, FPIDS, Professor of pediatrics, Feinberg School of Medicine, Northwestern University; pediatric infectious diseases attending, Ann & Robert H. Lurie Children's Hospital of Chicago, told 

 this expanded indication should help boost vaccination rates, though there are limitations.

"This intranasal live attenuated vaccine has been around for years as an option for influenza vaccination but utilization of the vaccine has been less than expected," Tan said. "It can only be given to healthy individuals 2 to 49 years of age with no underlying conditions, including asthma. Making it available for in home use should increase the use of this vaccine and influenza vaccine, however, it will be important that the selling of this vaccine be monitored as you do not want the wrong individuals receiving the vaccine." 

Tan added caution and attention to instruction for FluMist for self- or caregiver-administration should be taken, and that when available, the vaccine should help those weary of needles. 

"There will need to be clear instructions as to what should be done if the person does not receive the entire dose given that this is a nasal spray, but there is some volume to it, so parts of the dose could drip out of the nose," Tan said. "In home vaccine is not available this influenza season but is expected to be available next influenza season. It's definitely an option for needlephobic individuals."

"Today’s approval of the first influenza vaccine for self- or caregiver-administration provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families,” said Peter Marks, MD, PhD, in a press release from the FDA.

Marks is the director of the FDA's Center for Biologics and Evaluation and Research. "This approval adds another option for vaccination against influenza disease and demonstrates the FDA’s commitment to advancing public health.”

The common and contagious respiratory disease typically circulates during the fall and winter seasons in the United States. Per the Centers for Disease Control and Prevention (CDC), influenza has resulted in about 9.3 million to 41 million illnesses, 100,000 to 710,000 hospitalizations and 4,900 to 51,000 deaths annually between 2010 and 2023. 

Several vaccines approved by the FDA are available during the traditional influenza season, including those 

recommended by the CDC and the Advisory Committee on Immunization Practices (ACIP).

Fever over 100°F in children 2 through 6 years of age, runny nose and nasal congestion in individuals 2 through 49 years of age, and a sore throat in adults 18 through 49 years of age are the most commonly reported side effects of FluMist, according to the FDA. 

The agency noted that those interested in self- or caregiver-administration can expect the vaccine to be available via a third-party online pharmacy, and those who choose this option will complete a screening and eligibility assessment when they order FluMist. 

Caregivers should administer FluMist to individuals aged 2 to 17 years, "as individuals in this age group should not self-administer the vaccine," the FDA stated.

FDA Approves Nasal Spray Influenza Vaccine for Self- or Caregiver-Administration. FDA. Press release. September 20, 2024. Accessed September 20, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-nasal-spray-influenza-vaccine-self-or-caregiver-administration?utm_medium=email&utm_source=govdelivery

With this approval, FluMist becomes the first vaccine to prevent influenza that does not need to be administered by a health care provider. 

News

FDA approves FluMist for self- or caregiver-administration

It is no secret pediatricians play an unequivocally important role in effectively promoting healthy, active living through direct care, advocacy, and multiple forms of support.

 With growing responsibilities, lack of access to specialty care, and burnout, finding additional tools to help deliver the high standard of care for which pediatricians aim can only help.

When it comes to mental health issues among the pediatric population, digital therapeutics could help make a positive impact. According to Jason Kahn, PhD, researcher at Boston Children’s Hospital, instructor of psychiatry at Harvard Medical School, and chief scientific officer and founder of the Mightier digital therapeutic, these tools can be a stop-gap until specialized care is available. 

“I think a lot of pediatricians will be familiar with a lot of the core of the problem that's going on with kids and adults, but kids especially, which is access,” Kahn said. “We don't have a lot of psychiatrists, psychologists, even clinical social workers who can keep up with the demand that we are seeing when we look at kids with ADHD, anxiety, autism, depression, or any number of conditions that we’re seeing. All these prevalence rates are going up. Where digital therapies can step into the void if they can provide tools so kids can build skills, competencies, and strengths that can help them succeed and thrive while they are potentially on a waiting list for more specialized providers, these skills can then transfer into their lives. With these tools, we see kids having more success and getting help earlier when available.”

But what are digital therapeutics? They are technologies such as video games, that are designed to help overcome some limitations seen with conventional mental health care to reduce the risk of further development of these problems. According to a 2022 study published in 

, investigators noted these limitations can include limited access to specialty care, lack of intervention engagement, and unsustainable treatment effects. These digital therapies are developed to demonstrate “therapeutic effects on targeted mental health problems,” stated the investigators.

Kahn, founder of Mightier—a digital therapeutic that targets emotional regulation to help the child maintain the ability to think and keep control while playing video games built inside the device—explains why background and data are important aspects of digital therapeutics, and how Mightier works. 

“A digital therapeutic should be able to tell your patient, or the pediatrician, the evidence, what the target is, what the age is, how it's going to improve, and expectations for dosage. When all those parts play out, we should be able to say, 'this is what we expect when a kid is exposed to this,’” said Kahn. “For me, a digital therapeutic is something where the evidence is really well understood and we can put that in patients' hands, or kids’ hands in my case, and see some well-understood benefit.”

“The way Mightier works itself is that it's built on top of video games. Kids wear a heart rate monitor while they play, [which] allows us to take the moments of frustration that happen in the video game and then start to give kids feedback during those moments of frustration so they see themselves facing a challenge. Then they see their body change in the context of that challenge,” Kahn said in an interview with 

“Rather than just end there, we give the kid a course of action,” he added. “What we do to the game itself is a little counterintuitive to adults because we make the game harder. The child wants to be successful and they understand the language of a game, so they say, [theoretically], 'my body's an input. My emotions are an input. I'm going to be now incentivized to figure out a way to cool down.' We're also giving the kids help as they do this. We're showing them deep breathing exercises. We're showing them progressive muscle relaxation. A bunch of tools that they would be getting in a therapy office we're giving them so they understand what will help their body calm down at the moment, and we watch this progression as kids go through.” 

Kahn added that repetition is a key part of digital therapeutics, as the child can demonstrate over time how their frustration, focus, and body changes. This data is then used to transition the process into other aspects of the child’s life. 

“At the beginning, when they start Mightier, they use these resources, tools, they take the hints that we give them, and they'll use that to cool their body down,” he said. “As they do hundreds, if not thousands of these repetitions because it's a video game, it happens a lot and happens fast, they start becoming more automatic and more self-directed on how to cool down their body. That's the dream, right? We can see that transition in the game, and then we do have data that connects it and takes it from the game. Watching these kids become successful is really what we hope for.”

A 2021 proof of concept randomized controlled trial (NCT 01551732) that featured Mightier, referred to as Regulate and Gain Emotional Control (RAGE-Control) in literature works, was published in 

 Investigators, including Kahn, compared reduction in aggression, anger, oppositionality, and global severity between 2 treatment conditions, which were Anger Control Training (ACT) augmented with Mightier and ACT with a sham version of the game. Heart rate during gameplay was monitored and examined to explore associations between symptom changes and heart rate changes.

There were 40 youths with clinically significant anger dyscontrol aged 10 to 17 years included in the trial, which was conducted at Boston Children’s Hospital between July 2011 and February 2013. According to the investigators, the sample size was determined by power analysis, targeting 80% power to detect effect sizes (ES = 0.63–1.68) from a prior, preliminary, open-label study. Individuals were assigned randomly to 10 sessions of ACT with Mightier (n = 20) or ACT with the sham video game (n = 20). In the first 5 sessions, patients learned a specific coping skill to regulate their mood and behavior, then spent 15 minutes playing Mightier or the sham version of the game, during which they were instructed to use the previous coping skill learned. In sessions 6-10, structured problem solving was involved, “applying coping skills to real-life current problems and continued practice with the assigned version of RAGE-Control,” wrote the authors.

Results demonstrated that both treatments similarly reduced self-reported anger, but mightier treatment led to larger improvements in aggression (CI: –17 to –1.0, ES: 0.55, 

 = 0.015), oppositionality (CI: −9.0 to −7e-6, ES: 0.48, 

 = 0.032), and global severity (CI: −1.0 to −5e-6, ES: 0.51, 

 = 0.023) compared to the sham video game. Participants using Mightier also experienced larger pre-to-post decreases in heart rate, which was significantly associated with larger pre-to-post decreases in aggression and oppositional behaviors.

“Emotional regulation is this ability when you are frustrated, when you have hot emotions, to sort of maintain your cool, maintain your ability to think and stay present and then be successful,” Kahn said. “We see emotional regulation on both the deficit side and the strength side. Kids who have neurodevelopmental diseases like ADHD or autism typically have less emotional regulation. It also shows up in anxiety sometimes. On the flip side, we do see that kids who are particularly resilient and particularly successful in social settings tend to have a lot of emotional regulation.” 

Kahn and coauthors of the study concluded that findings supported that augmenting traditional treatment with technology through skill practice can translate to real-life behavioral change and enhancements. Kahn stated awareness of digital therapeutics might be low, and he wants health care providers to know these technologies exist and can help facilitate care.

“We're asking pediatricians to do more and more, and I don't think we've done a great job helping pediatricians understand how the digital mental health landscape is evolving and changing, and what options are available to them,” he said. “Trying to get the word out and have pediatricians understand what these tools are, I think, is one of the biggest challenges, especially in the context of asking pediatricians to be all sorts of people and wear all sorts of hats for the patients coming into their offices.”

Jason Kahn, PhD disclosed the following to Contemporary Pediatrics: 

Board membership - Neuromotion Inc d/b/a Mightier

Employment - Neuromotion Inc d/b/a Mightier

Grants received/research funding - NIH - R44MH124574

1. Muth ND, Bolling C, Hannon T, Sharifi M. The role of the pediatrician in the promotion of healthy, active living. 

. March 2024; 153 (3): e2023065480. 10.1542/peds.2023-065480

2. Zarefsky M. Most pediatricians have burnout. Here’s what it takes to fix that. American Medical Association. January 8, 2024. Accessed August 8, 2024. https://www.ama-assn.org/practice-management/physician-health/most-pediatricians-have-burnout-here-s-what-it-takes-fix

3. Choi E, Yoon EH, Park MH. Game-based digital therapeutics for children and adolescents: Their therapeutic effects on mental health problems, the sustainability of the therapeutic effects and the transfer of cognitive functions. 

. 2022;13:986687. doi:10.3389/fpsyt.2022.986687

4. Ducharme P, Kahn J, Vaudreuil C, et al. A “proof of concept” randomized controlled trial of a video game requiring emotional regulation to augment anger control training. 

. 2021;12:591906. doi:10.3389/fpsyt.2021.591906 

Digital therapeutics help kids build emotional regulation and coping skills, supporting pediatric care while waiting for specialized mental health services.

Digital therapeutics and what they can do for mental health

Andrew Dauber, MD, MMSc, of Children's National Hospital joined us to talk PGHD and the role of the pediatrician when it comes to treatment. 

A discussion of pediatric growth hormone deficiency with Andrew Dauber, MD, MMSc

Andrew Dauber, MD, MSSc, Chief of Endocrinology at Children’s National Hospital in Washington, DC, discussed standard of care for pediatric growth hormone deficiency and how the general provider can play a role in a multidisciplinary team when it comes to treatment.

“For many years, the standard of care treatment for growth hormone deficiency was to receive daily injections of growth hormone,” Dauber explained. “Recombinant human growth hormone was made for the first time in the mid-1980s, so that's been around for around 40 years, and is very effective.” However, despite its efficacy, the treatment regimen has downsides. 

“The obvious downside of it is that it's a daily injection treatment, and kids need to be on it for many, many years, right? So if they get diagnosed at age 6 or 7 or 8, they can continue on daily injections through all of puberty, until they're done growing and sometimes even into adulthood,” said Dauber. This long-term daily treatment can be challenging for both patients and their families. 

“In the last few years, there's now been weekly formulations of growth hormone approved,” Dauber noted. “There are actually in America 3 different once-a-week injectables, and those all work quite well.” 

While these weekly injections offer a more convenient alternative, they still come with certain challenges. “The major downside of those are still that it's an injection, so there's some kids, patients, and families who really would prefer, obviously, to avoid injection medicine,” Dauber stated. Additionally, the cost of these weekly injections remains a barrier for many families. “And they're also still quite expensive. So those are, I would say, the 2 major barriers.”

Dauber emphasized that compliance remains an issue with any long-term medication, especially when injections are involved. “We know, with any long-term medicine, and especially injectable medicines, there's a decrease in compliance over time, and that really affects outcomes for these patients,” he explained.

The introduction of weekly growth hormone injections represents a significant advance in the treatment of GHD, offering greater convenience and efficacy. However, challenges related to cost, injection discomfort, and compliance still need to be addressed to optimize patient care and outcomes.

Pediatricians, in collaboration with endocrinologists, continue to play an essential role in monitoring patient progress and ensuring optimal outcomes for children with GHD. 

Andrew Dauber, MD, MMSc, of Children's National Hospital joined us to talk PGHD and the role of the pediatrician when it comes to treatment.

Alan Percy, MD, discusses where the general provider comes in when treating Rett syndrome and prescribing trofinetide (Daybue). 

The pediatrician's role in prescribing trofinetide for Rett syndrome

Alan Percy, MD, Professor of Pediatrics, Neurology, Neurobiology, Genetics, and Psychology at the University of Alabama, Birmingham, and lead author of the LILAC-1 and LILAC-2 studies, recently discussed the role of physicians in prescribing trofinetide (Daybue; Acadia Pharmaceuticals) for Rett syndrome. His observations highlight important developments in the prescribing process, while also emphasizing the collaborative effort needed to optimize patient care.

"It's very interesting, and I can't give you an exact percentage, but maybe as high as 50% or so of the children that we have seen have had the medication prescribed by their private physician," Percy noted. "So the private physicians are being informed by the parents that this medication is available, and they are reaching out to the pharmacists to gain approval." 

 "I think that general physicians should be quite confident in being able to prescribe this. They should reach out to so-called centers of excellence," he explained. For physicians unfamiliar with the treatment, these centers can offer guidance and support, helping to bridge the knowledge gap.

Percy also provided practical advice on how to begin administering the medication, particularly for physicians who may be new to treating Rett syndrome. "They also should know that they can start at, say, 50% of the recommended weight-based dose and increase gradually. We have had individuals who have increased by 1 milliliter a week," Percy said. Although this approach might seem slow, he emphasized the importance of gradual increases to minimize side effects and achieve the optimal dose.

As the treatment becomes more widely prescribed, feedback from parents remains crucial. Percy expressed a desire for greater communication between physicians and families, stating, "The question always is, at the end of 6 months or a year, what are the parents seeing? And that is something that we would like to know." 

Alan Percy, MD, discussed what the FDA approval of trofinetide (Daybue) has meant to patients with Rett syndrome aged 2 years and older.

Discussing trofinetide data, FDA approval for Rett syndrome with Alan Percy, MD

Alan Percy, MD, Professor of Pediatrics, Neurology, Neurobiology, Genetics, and Psychology at the University of Alabama, Birmingham, and the lead author for the LILAC-1 and LILAC-2 studies, recently discussed significant advancements in the treatment of Rett syndrome, highlighting the FDA approval of trofinetide (Daybue; Acadia Pharmaceuticals), approved on March 13, 2023. Percy also discussed the recent long-term safety data for trofinetide, based on a pair of open-label extension studies LILAC-1 and LILAC-2.

"Actually, it's quite interesting that while there is great enthusiasm among parents of children, the survival in Rett syndrome is quite long. So average survival is over age 50. So, many adult women with Rett syndrome are also taking this medication," Percy explained, noting the trofinetide approval marked a significant milestone in the direct management of Rett syndrome symptoms. 

Percy emphasized the groundbreaking nature of this treatment, noting that "this was the first product that was ever has been developed and approved by the FDA for direct treatment of the signs or symptoms of Rett syndrome. Other medications we use are for symptomatic care, but nothing has been available previously to direct at the basic underpinnings of Rett syndrome." 

The pivotal trial for this treatment, known as the LAVENDER trial, was a "double-blind, placebo-controlled study lasting 12 weeks," Percy explained. The trial utilized the Rett Syndrome Behavioral Questionnaire (RSBQ) and the Clinical Global Impression of Improvement (CGI-I) as primary endpoints to measure the treatment's effectiveness. "What is quite remarkable is at the end of the first pivotal trial, 12 weeks both the RSBQ and the CGI-I showed improvement." 

LILAC-1 was a 40-week, open-label extension of the LAVENDER trail and evaluated safety and efficacy of trofinetide in patients with Rett syndrome aged 5 to 21 years. LILAC-2 was a 32-month open-label extension evaluating trofinetide in females aged 5 to 22 years who had completed LILAC-1, according to Acadia Pharmaceuticals.

The most common side effects in the trials were diarrhea and vomiting.

Percy acknowledged that while the treatment shows significant promise, it is not without challenges. "I think it is important to mention that diarrhea can be a substantial problem, and there may be individuals who have to stop the treatment simply because the diarrhea is not manageable." However, he pointed out that strategies have been developed over time to manage this side effect more effectively. "We start at 50% of the recommended weight-based dose, and we gradually increase to the point of maximum tolerability."

Clinical data from open-label extension LILAC-1 and LILAC-2 studies evaluating long-term safety and efficacy of Daybue (trofinetide) in patients with rett syndrome published in med. Acadia Pharmaceuticals. Press release. July 18, 2024. Accessed September 4, 2024. https://ir.acadia.com/news-releases/news-release-details/clinical-data-open-label-extension-lilac-1tm-and-lilac-2tm

FDA approves first treatment for Rett Syndrome. FDA. Press release. March 13, 2023. Accessed September 4, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-treatment-rett-syndrome 

Gordon Gray Still, MD

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