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Articles

. 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.

A new study found that cell-free DNA from routine prenatal testing can accurately identify preterm birth risk without added cost or procedures. 

New blood test predicts preterm birth risk early in pregnancy

In 3 studies evaluating the effects of probiotics on eczema, probiotics groups reported a greater reduction in symptoms than placebo groups, but only when the allergy was IgE mediated. 

Do probiotics reduce allergy symptoms? It’s complicated!

 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.

From the FDA approvals of dupilumab and maralixibat tablets to a new puzzler case study, get caught up with our weekly review article. 

Weekly review: FDA approves dupilumab, ACIP meets, and more

The CRL issued by the FDA to Regeneron for extended EYLEA HD dosing to 24 weeks cited no safety or efficacy concerns.

FDA issues CRL for aflibercept 8 mg extended dosing for all indications

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Authors

An otherwise healthy 6-month-old boy has a 1-cm area of recurrent blistering with surrounding erythema on his right cheek that developed shortly after birth.

A 6-month-old male with solitary mastocytoma

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

 poll. Take a look at the following case below. After reading through the description, choose a multiple-choice answer and try to guess the correct patient diagnosis.

This case was presented by Rutva Vora, BS; and Monica Guirguis, DO.

A 2-month-old female was born after an uneventful pregnancy at 40 weeks’ gestation via vacuum-assisted vaginal delivery to a G2P1011 female. The patient’s APGAR scores were 7 and 9 at 1 and 5 minutes, respectively, at birth. No bleeding or other complications were reported during delivery. The newborn and mother were discharged two days after delivery without requiring NICU stay or interventions. The infant briefly developed a small soft palpable scalp swelling that resolved within days after delivery. The patient followed an otherwise uncomplicated growth progression since birth. She did exhibit mild reflux symptoms, which were managed with supportive care measures. Physical examination after delivery and subsequent exams revealed no abnormalities, including no signs of scalp swelling or injury.

At 8 weeks of age, the patient presented to the Emergency Department with a 3-day history of new-onset scalp swelling. The parents decided to seek medical attention after the swelling became noticeably enlarged. Parents denied any changes in her mental status, vomiting, fevers, lethargy, irritability, or any other new concerns. She did have symptoms of gassiness and fussiness that were unchanged from baseline. No history of trauma was reported, and there were no concerning signs suggestive of nonaccidental trauma. The patient appeared well, with a soft, fluctuant palpable subcutaneous fluid collection overlying the parieto-occipital scalp, without crossing suture lines. The anterior fontanelle was soft and non-bulging, and there was no hemotympanum.

Bleeding disorder (e.g. Von Willebrand Disease)

Can you diagnose this patient? Take our poll and find out! Then check back for the full case, differential diagnosis, and correct diagnosis.

Case Studies

Diagnose this 2-month-old with scalp swelling

On April 18, 2025, the FDA approved a resubmitted supplemental biologics license application (sBLA) for dupilumab (Dupixent; Regeneron and Sanofi) to treat chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older, according to a press release from Regeneron.

The interleukin (IL)-4 and IL-13 inhibitor for this CSU indication is designed to treat those whose disease is not adequately controlled with H1 antihistamine treatment, and is the first targeted therapy for CSU in over a decade.

With the federal agency's decision, CSU is now the 7th disease with underlying type 2 inflammation in which dupilumab is approved.

"[Dupilumab] is the first new targeted treatment for CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease,” said George D. Yancopoulos, MD, PhD, in a statement. Yancopoulos is the board co-chair, president, and chief scientific officer at Regeneron. "With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions. We look forward to bringing Dupixent to the more than 300,000 CSU patients in the U.S. with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options," added Yancopoulos.

Data that led to dupilumab approval for CSU 

Acceptance of the sBLA was based on data from the LIBERTY-CUPID phase 3 clinical program that featured Study A, Study B, and Study C. This sBLA added results from Study C, which was carried out in patients with uncontrolled CSU who were on standard-of-care antihistamines. This study met primary and key secondary endpoints that confirmed results in Study A.

Study A and Study C were phase 3, randomized, placebo-controlled, double-blind trials, that compared dupilumab with placebo in symptomatic CSU patients despite H1-AH—the treatment met the primary and all key secondary outcomes. According to data 

, Study A was made up of omalizumab-naive patients aged 6 years and up (n = 138) while Study B featured omalizumab-intolerant/incomplete responders aged 12 years and older (n = 108). 

Both Weekly Urticaria Activity Score (UAS7) and Weekly Itch Severity Score (ISS7) improved with dupilumab compared to treatment in Study A, according to data published in 

The Journal of Allergy and Clinical Immunology 

((difference -8.5 [95% CI, -13.2 to -3.9; (difference -8.5 [95% CI, -13.2 to -3.9; 

 = .0003] and -4.2 [95% CI, -6.6 to -1.8; 

Trial investigators noted that in Study B, UAS7 improved (difference -5.8 [95% CI, -11.4 to -0.3; 

 = .0390]), with a numerical trend in ISS7 (difference -2.9 [95% CI, -5.7 to -0.07; nominal 

 = .0449, not significant]). Pooled safety data across each study revealed consistency between dupilumab and placebo, which aligned with the known safety profile of dupilumab.

Dupilumab improves itch and hives in CSU patients 

The chronic inflammatory skin disease is characterized by the sudden onset of hives on the skin or swelling under the skin. Study C enrolled 151 children and adults to receive either dupilumab (n = 74) or placebo (n = 77), added to standard-of-care histamine-1 (H1) antihistamines, Sanofi previously announced. At 24 weeks, efficacy for patients receiving dupilumab, compared to placebo, was:

8.64-point reduction in itch severity from baseline with dupilumab versus a 6.10-point reduction with placebo (

15.86-point reduction in urticaria activity (itch and hive) severity from baseline with dupilumab vs an 11.21-point reduction with placebo (

30% of dupilumab-treated patients reported no urticaria, or complete response, compared to 18% individuals on placebo (

1. Dupixent (dupilumab) Approved in the US as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU). Regeneron. Press release. April 18, 2025. Accessed April 18, 2025. https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-new-targeted-therapy-over

2. Fitch, J. FDA accepts application for dupilumab to treat chronic spontaneous urticaria. Contemporary Pediatrics. November 15, 2024. Accessed April 17, 2025. https://www.contemporarypediatrics.com/view/fda-accept-application-for-dupilumab-to-treat-chronic-spontaneous-urticariaContemporary Pediatrics. November 15, 2024. Accessed April 17, 2025. https://www.contemporarypediatrics.com/view/fda-accept-application-for-dupilumab-to-treat-chronic-spontaneous-urticaria 

3. Maurer M, Casale TB, Saini SS, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): Two randomized, double-blind, placebo-controlled, phase 3 trials. 

. 2024 Jul;154(1):184-194. doi:10.1016/j.jaci.2024.01.028. Epub 2024 Feb 29. PMID: 38431226 

4. Press Release: Dupixent phase 3 study confirms significant improvements in itch and hives for patients with CSU. Sanofi. Press release. September 11, 2024. Accessed April 17, 2025. https://www.sanofi.com/en/media-room/press-releases/2024/2024-09-11-05-05-00-2944239 

The sBLA for dupilumab (Dupixent) was supported by data from the phase 3 LIBERTY-CUPID clinical program in patients with uncontrolled CSU. 

News

FDA approves dupilumab for chronic spontaneous urticaria in ages 12 and up

 poll. Take a look at the following case below. After reading through the description, choose a multiple choice answer and try to guess the correct patient diagnosis. 

This case was presented by Rylee Moody, BS; Mary Gibney, MD;and Elaine Siegfried, MD

A 21-month-old girl presented with a history of "skin tags" involving her gluteal cleft,noted at birth (Figure 1A). She was otherwise healthy and developing normally. Notably, her older sister had a confirmed history of molluscum contagiosum (MC).

Skin exam featured three prominent2-4 mm soft, pedunculated papules within the superior aspect of hergluteal cleft, as well as sparsely scattered 1-2 mmpapulescharacteristic of MC on the gluteal prominences and in mirror distribution on the perianal mucosa.

Click here to view the full case presentation, differential diagnosis, and the correct diagnosis for this patient.

Can you diagnose this patient? Take our poll and find out! Then check back for the full case, differential diagnosis, and correct diagnosis. 

Diagnose this 21-month-old with history of “skin tags” on her gluteal cleft 

Recent research detailed that a child was most likely to be killed in a mass shooting by a parent or family member vs a stranger or peer. Study investigator Stephanie Chao, MD, breaks down these data. 

Stephanie Chao, MD details relationships in mass shootings involving children

Stephanie Chao, MD, FACS, FAAP, associate professor of Pediatric Surgery at Stanford Medicine Children’s Health, has dedicated her research to understanding the true risks of firearm-related mass shootings involving children. Motivated by both her professional expertise and personal experience as a mother, Chao became concerned after her young daughter described an active shooter drill at school.

“She told me, ‘Well, the teacher said, in case there’s a bear outside, this is what we should do,’” Chao recalled. “I just thought that that was incredible in that the teacher had to create a story.” This experience led Chao to question the effectiveness of school-based active shooter drills and examine where the true threats to children exist.

Chao co-authored a recent study published in 

, which analyzed mass shootings involving child victims. The study defined pediatric mass shootings as incidents in which at least 4 people were killed, excluding the perpetrator, and at least 1 of the victims was under 18 years old.

Researchers reviewed 121 incidents between 2009 and 2020, which resulted in 308 child fatalities. The study found that 59.1% of these deaths were perpetrated by a family member, with parents alone responsible for 40.9% of all mass shooting deaths. In contrast, classmates accounted for just 6.8% of child fatalities.

“I was surprised by our findings,” Chao said. “We found in our study that 59% of mass shootings that involved children dying were committed by a relative, and 41% of those shootings were committed by a parent. Only a very small percentage, by comparison, was committed by a classmate.” 

Chao emphasized the role of pediatricians in addressing firearm safety. 

“I think pediatricians are really on the front lines with kids,” she said. “They see all the small booboos, they see the cold, but they also see the things that are the beginnings of lifelong trauma.” However, discussing firearm safety remains a challenge in clinical settings. Chao noted that even seasoned pediatricians find conversations about gun safety uncomfortable and difficult to fit into busy patient visits.

One of Chao’s ongoing research projects, PLEDGE, aims to bridge this gap by developing a school-based curriculum focused on gun safety, safe storage, and mental health awareness. 

Maria Fazal, MS3, MA

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