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Pediatrics

Monthly pediatrics bulletin — September 18, 2026

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MONTHLY PEDIATRICS BULLETIN — September 18, 2026
Period covered: August 19 – September 18, 2026.

Neonatology and perinatal

1. Four in five neonatal and infant deaths would be preventable: eight years of CHAMPS surveillance in seven countries

[Epidemiology] [Sub-Saharan Africa and South Asia; CDC/MMWR]
On September 8, MMWR Surveillance Summaries published results from the CHAMPS network (Bangladesh, Ethiopia, Kenya, Mali, Mozambique, Sierra Leone and South Africa, December 2016–December 2024). Of 18,784 eligible deaths, 8,500 (stillbirths, neonates and children under 5) had a complete investigation with minimally invasive tissue sampling, laboratory testing and verbal autopsy. Among the 3,230 neonatal deaths, complications of prematurity dominated (~40%), followed by asphyxia/hypoxia (~38%) and sepsis (~37%), the latter with gram-negative organisms in ~86% of cases with an identified pathogen and Klebsiella pneumoniae in nearly half. 80.7% of deaths were judged preventable or possibly preventable; 44% of neonatal deaths had two or more concurrent causes.
Why it matters: This is the largest study of causes of death with pathological confirmation in low- and middle-income countries, but the catchment areas are not nationally representative, hospital deaths are overrepresented, and "preventability" is an expert judgment. The burden of perinatal asphyxia and multidrug-resistant gram-negative sepsis is directly transferable to the discussion on neonatal resuscitation and empiric antibiotic policy in Dominican units.
Source: https://doi.org/10.15585/mmwr.ss7506a1

2. Synbiotic with Bifidobacterium and human milk oligosaccharides: safe and colonizes the infant gut (ARTEMIS trial)

[Industry] [United States]
Randomized, placebo-controlled trial in 114 participants (58 infants aged 2 to 12 months and 56 children aged 12 to 24 months) with a synbiotic of four Bifidobacterium strains, four human milk oligosaccharides and vitamin D. There were no differences in adverse events or gastrointestinal symptoms versus placebo; colonization was detected in 72% of infants and 67% of toddlers at 4 weeks. An exploratory analysis suggested better sleep quality in the 12-to-24-month group.
Why it matters: This is a manufacturer-sponsored (Persephone Biosciences) safety and colonization study, with a small sample, parent-reported outcomes and no hard clinical endpoint; it does not change practice or replace the evidence for probiotics in preterm infants for necrotizing enterocolitis.
Source: https://www.contemporarypediatrics.com/view/bifidobacterium-based-synbiotic-shows-safety-and-gut-colonization-in-infants-and-toddlers

Infectious disease, vaccines and emergency care

3. AAP expands RSV immunization criteria for the second season (8 to 19 months)

[Guideline] [United States; AAP, Pediatrics]
Policy statement from the Committee on Infectious Diseases published online September 2 (Pediatrics, doi 10.1542/peds.2026-079047). A single dose of nirsevimab or clesrovimab, with no product preference, remains recommended for all infants under 8 months who are born into or entering their first season, unless protected by maternal RSVpreF vaccination ≥14 days before delivery. For the 2026-2027 season, high-risk criteria are expanded from 8 to 19 months: prematurity <32 weeks regardless of support, hemodynamically significant congenital heart disease, pulmonary or neuromuscular anomalies, Down syndrome and other chromosomal disorders, bronchopulmonary dysplasia with support in the prior 6 months, severe immunosuppression, selected cystic fibrosis, and American Indian and Alaska Native children. Nirsevimab is the only product indicated in the second season, based on chronological age and independent of maternal vaccination or prior dosing.
Why it matters: This is backed by consistent real-world effectiveness (60–80% against hospitalization in European and US series), but the expanded criteria rely more on epidemiological risk than on subgroup-specific trials. In the Dominican Republic, where neither nirsevimab nor clesrovimab is in the public schedule, the value lies in guiding private prescribing and prioritizing infants born <32 weeks and those with heart disease.
Source: https://www.aap.org/en/news-room/news-releases/aap/2026/american-academy-of-pediatrics-issues-recommendations-for-rsv-immunizations-2026-2027/

4. Measles in the Americas: 52,676 confirmed cases and 61 deaths through September 5

[Epidemiology] [Region of the Americas; PAHO]
PAHO situation report No. 11 (September 11; epidemiological weeks 1–35) tallies 52,676 confirmed cases in 17 countries and territories, 3.8 times more than the same period in 2025, with 61 deaths (Guatemala 41, Mexico 19, Bolivia 1). Guatemala has accumulated 33,334 cases, Mexico 12,848, the United States 3,134, Peru 1,997 and Canada 1,119 (99.5% of the total). In weeks 33–34, 911 new cases were reported in six countries, 36.6% fewer than in the previous two weeks.
Why it matters: The recent trend is downward, but the magnitude (the United States has already exceeded its 2025 total and risks its elimination status) and the 93% of cases in unvaccinated individuals call for strict surveillance of fever with rash and verification of two doses of MMR at every clinical encounter; the country does not appear among the most affected in the summary, but the risk of importation through tourism and migration is high.
Source: https://www.paho.org/en/documents/situation-report-11-measles-americas-region-11-september-2026

5. Nirsevimab associated with fewer antibiotic prescriptions in infants (target trial emulation, CHOP)

[Publication] [United States; Clinical Infectious Diseases]
Target trial emulation study using medical records from 32 primary care practices in the Children's Hospital of Philadelphia network: 15,341 infants under 8 months (mean age 3.5 months), of whom 7,413 received nirsevimab. Compared with unimmunized infants, nirsevimab was associated with 14.4% fewer antibiotic prescriptions for outpatient acute respiratory infections, 40.3% fewer for outpatient bronchiolitis, and 69.4% fewer for RSV-related hospitalizations.
Why it matters: This is a retrospective observational design in a single regional network, without confidence intervals in the press coverage, with possible residual confounding and missed prescriptions outside the network; even so, it adds an antimicrobial stewardship argument to RSV prevention, relevant for a country with high bacterial resistance.
Source: https://doi.org/10.1093/cid/ciag406

6. 2026-2027 COVID-19 vaccine: AAP recommends universal dosing from 6 to 23 months and risk-based dosing from 2 to 18 years

[Guideline] [United States; AAP, Pediatrics]
Policy statement and technical report (Pediatrics, doi 10.1542/peds.2026-079045 and -079046) published September 2. Recommends universal vaccination from 6 to 23 months; from 2 to 18 years, a dose for children with risk conditions, in congregate care, never vaccinated, or living with vulnerable people, and available at parental request; two or more doses in the immunocompromised. Supporting data: infants under 6 months had a cumulative hospitalization rate of 251.4 per 100,000 in 2024-2025, higher than adults aged 65 to 74; the 2024-2025 dose's effectiveness against emergency visits was 76–77% in children aged 9 months to 4 years and 45–56% in those aged 5 to 17; fewer than 4% of eligible hospitalized children were up to date.
Why it matters: The AAP explicitly diverges from the recent federal US schedule; the effectiveness evidence is observational, and post-vaccination myocarditis has fallen to 1.24 per million doses with current formulations. For the Dominican context, where the pediatric COVID vaccine has limited availability, this serves as a technical reference for risk groups.
Source: https://doi.org/10.1542/peds.2026-079045

General pediatrics, growth and development

7. Weekly semaglutide in children aged 6 to 11 with obesity: 40.4% exit the obesity range (STEP Young, preliminary results)

[Industry] [Denmark; multinational trial, Novo Nordisk]
Novo Nordisk announcement of September 7 on the phase 3 STEP Young trial: 165 children aged 6 to <12 with obesity (more than 85% with class II or III obesity), randomized to weekly subcutaneous semaglutide (maximum dose 1.7 or 2.4 mg depending on baseline weight) or placebo, both with a hypocaloric diet and physical activity, for 68 weeks. The primary endpoint (percentage change in BMI) was met, with no figures published; on the confirmatory secondary endpoint, 40.4% of treated children had a BMI below the 95th percentile at 68 weeks versus 0% with placebo. Safety was described as consistent with prior studies, with no signals regarding growth or puberty.
Why it matters: This is a preliminary results announcement without peer review, without the magnitude of the primary endpoint or adverse event data, and the "on-product" estimand assumes full adherence; full data will be presented at ObesityWeek (November 14–17). It extends to school-age children evidence already established in adolescents, but long-term safety regarding growth and pubertal development remains unresolved, and cost puts it out of reach for most Dominican families.
Source: https://www.globenewswire.com/news-release/2026/09/07/3357042/0/en/novo-nordisk-step-young-phase-3-data-40-4-of-children-living-with-obesity-achieved-a-bmi-below-the-obesity-threshold-with-semaglutide-and-lifestyle-modification.html

8. Vosoritide improves growth velocity in hypochondroplasia: phase 3 CANOPY-HCH-3 trial

[Clinical trial] [Multinational, 23 centers in 9 countries; NEJM Evidence, sponsored by BioMarin]
Published September 9 in NEJM Evidence and presented at ESPE 2026. 81 children aged 3 to <18 with confirmed hypochondroplasia and height ≤ −2 SD, randomized 1:1 to daily subcutaneous vosoritide (n=41) or placebo (n=40) for 52 weeks. Annualized growth velocity changed by +1.95 cm/year with vosoritide versus −0.39 cm/year with placebo (difference 2.33 cm/year; 95% CI 1.85–2.82; p<0.0001); standing height was 2.35 cm greater and height Z-score improved by 0.39. No grade 3 or higher adverse events or discontinuations; more injection-site reactions with the drug.
Why it matters: This is a well-designed but one-year, manufacturer-sponsored trial with a surrogate endpoint (growth velocity, not adult height); it excluded children under 3 and mild forms. The indication-expansion application is already before the FDA; access to vosoritide is exceptional in our setting.
Source: https://doi.org/10.1056/EVIDoa2600257

9. FDA approves apitegromab (Isembyld), first muscle-directed drug for spinal muscular atrophy

[FDA regulatory] [United States; Scholar Rock]
Approval on September 11 for patients aged 2 years or older with SMA already receiving SMN2-directed treatment (nusinersen or risdiplam). Basis: the SAPPHIRE trial (NCT05156320), 52 weeks, 188 non-ambulatory patients aged 2 to 21, with the primary analysis in 156 patients aged 2 to 12. With 10 mg/kg IV every 4 weeks, the HFMSE scale improved by 2.2 points versus placebo (nominal p 0.0121); 34.2% achieved an improvement of ≥3 points versus 13.5% with placebo. Adverse events: respiratory infections, vomiting, headache, and increased fracture risk.
Why it matters: This is an add-on, not a replacement, treatment with a modest but clinically measurable effect in patients who kept losing function despite background therapy; fracture risk and cost are the practical limitations.
Source: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-therapy-target-muscle-loss-spinal-muscular-atrophy

10. First gene therapy for Sanfilippo syndrome type A (MPS IIIA): FDA approves Fayuvi

[FDA regulatory] [United States; Ultragenyx]
On September 17, the FDA approved rebisufligene etisparvovec (Fayuvi), a single-dose intravenous AAV9 gene therapy delivering the SGSH gene. Approval is based on an open-label, single-arm, multicenter study in children aged 2 to 5 (median follow-up 4.8 years) whose treated patients maintained or improved cognitive function compared with an untreated historical cohort. Adverse events >5%: elevated transaminases, nausea and vomiting, fever, cytopenias; warnings for thrombotic microangiopathy and a theoretical risk of genomic integration; requires corticosteroids starting the day before and for at least 8 weeks.
Why it matters: This is the first therapeutic option in a lethal neurodegenerative disease, but the evidence is single-arm with a historical control and no effect figures given in the announcement; long-term safety follow-up is mandatory.
Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-pediatric-patients-sanfilippo-syndrome-type

11. Pegcetacoplan reduces proteinuria 75% in adolescents with C3 glomerulopathy and IC-MPGN (VALIANT trial subgroup)

[Publication] [United States; CJASN, subanalysis funded by Apellis/Biogen]
Prespecified adolescent subgroup of the phase 3 VALIANT trial (NCT05067127; total n 124, age ≥12, biopsy-confirmed C3G or primary IC-MPGN), published in the Clinical Journal of the American Society of Nephrology and released September 17. In 55 adolescents, twice-weekly subcutaneous pegcetacoplan reduced proteinuria 75% versus placebo at 26 weeks (95% CI 59–84%; nominal p<0.001); 71% versus 4% achieved a ≥50% reduction, and 57% versus 4% achieved the composite of stable renal function with ≥50% reduction.
Why it matters: This is an underpowered subgroup with nominal p-values and optional biopsy in some adolescents; even so, it is among the few randomized data points in pediatric nephrology this year and supports the indication already approved from age 12. It requires vaccination against encapsulated organisms because of meningococcal infection risk.
Source: https://investors.biogen.com/news-releases/news-release-details/phase-3-pediatric-empaveli-data-published-clinical-journal

12. New AAP clinical report on iron deficiency: ferritin in screening and early supplementation in preterm infants

[Guideline] [United States; AAP and ASPHO, Pediatrics 2026;158(1)]
Joint clinical report from the Section on Hematology-Oncology, the Committee on Nutrition and ASPHO (doi 10.1542/peds.2026-077414), disseminated and discussed in specialty press this month. Main changes: screening with complete blood count and ferritin at 9–12 months in breastfed infants and 15–18 months in formula-fed infants, annually through age 4 if risk factors are present, and in menstruating adolescents one year after menarche or at age 14; ferritin thresholds <20 ng/mL in children and <30 ng/mL in adolescents; supplementation of 1 mg/kg/day in breastfed infants from 4 months and 2–3 mg/kg/day in preterm infants from 2 weeks; treatment with 3 mg/kg/day of elemental iron (65 mg/day in adolescents) for 3 months, with follow-up at 1 and 3 months.
Why it matters: The report was published in the July issue of Pediatrics, so it slightly exceeds this month's window, but its practical dissemination has occurred in September and changes routine screening. The ferritin recommendation is reasonable but raises screening costs and must be interpreted as an acute-phase reactant; in our setting, with high prevalence of iron-deficiency anemia, the most applicable measure is systematic supplementation of preterm infants and breastfed infants.
Source: https://doi.org/10.1542/peds.2026-077414

Pediatric surgery and surgical subspecialties

13. FDA Pediatric Advisory Committee (September 16): safety review of scoliosis devices, the Contegra conduit and Epicel, and of pediatric-use drugs

[FDA regulatory] [United States]
The meeting reviewed annual reports for devices with a humanitarian device exemption used in pediatric surgery: The Tether (vertebral body tethering for idiopathic scoliosis), the Reflect Scoliosis Correction System, MID-C, the Contegra pulmonary valved conduit, Epicel cultured epidermal autografts for burns, Enterra, Liposorber and Sonalleve MR-HIFU; and postmarketing pediatric safety of remdesivir, ophthalmic atropine, dalbavancin, dasatinib, atezolizumab, intranasal naloxone and others. The published material is surveillance documentation, with no new efficacy data.
Why it matters: There are no new verifiable surgical trials in the past month (recent RCTs on ERAS in complicated appendicitis in Mexico and on nonoperative treatment of simple appendicitis are from April and earlier months, already covered). The FDA's agenda is useful for those using The Tether or Contegra: it is worth reviewing the adverse event reports published on that page.
Source: https://www.fda.gov/advisory-committees/pediatric-advisory-committee/briefing-materials-september-16-2026-meeting-pediatric-advisory-committee

Cross-cutting: regional child health and events

14. Dominican epidemiological snapshot 2026 (SINAVE, through week 29): dengue and leptospirosis rise, malaria and infant mortality fall

[Epidemiology] [Dominican Republic; SINAVE via Hoy]
According to reports from the National Epidemiological Surveillance System through epidemiological week 29 (published August 16): dengue 213 confirmed cases versus 173 in 2025 (+20%, with greater burden in Santo Domingo and the endemic corridor in the security zone); malaria 115 versus 673 (−83%, foci in Azua and San Juan); leptospirosis 253 versus 85 (+190%, led by Puerto Plata); pertussis 7 cases versus 1; tetanus 16 cases and 6 deaths; infant mortality 992 versus 1,093 (−9.2%), mostly neonatal; case fatality of severe acute respiratory infection rose from 0.7 to 3.7 per 100 cases.
Why it matters: This is administrative surveillance data, not a study, and 33 days old, but it is the only recent national snapshot: the upturn in pertussis and leptospirosis and the case fatality of severe ARI are signals to reinforce pentavalent/DPT vaccination and clinical suspicion in the febrile child. The Dominican Society of Pediatrics reaffirmed on August 12 its unrestricted support for the national vaccination schedule.
Source: https://hoy.com.do/el-pais/republica-dominicana-reduce-malaria-colera-suben-infecciones-respiratorias-graves_1098696.html

15. Riyadh hosted the 24th International Neonatology Congress of the Saudi Neonatology Society (September 15–17)

[Congress] [Saudi Arabia]
The Saudi Neonatology Society held its 24th international congress in Riyadh from September 15 to 17, with local and international speakers, sessions and workshops; press coverage does not detail results of studies presented.
Why it matters: Included as a reference to regional scientific activity; there is no verifiable clinical data in the source. No new, verifiable pediatric trials dated August-September were found this month in searches in Japanese, Chinese, Korean, Russian, Turkish, German or Portuguese; what turned up in those languages were guidelines or studies from earlier months. (Source in Arabic)
Source: https://sabq.org/article/d8212yo

Upcoming meetings and dates

AAP National Conference & Exhibition 2026, San Diego, October 2–6, 2026 (http://aapexperience.org).
ObesityWeek 2026, Washington DC, November 14–17: presentation of the full STEP Young results (semaglutide in children aged 6 to 11).

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