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Newborn News

Topical Antibiotic Eradicates S. Aureus in NICU Infants

Applying mupirocin, a topical antibiotic, to various body areas safely and effectively eliminates Staphylococcus aureus (SA) colonization on infants in the neonatal intensive care unit (NICU), according to researchers.

University of Maryland researchers conducted a phase 2 multicenter, open-label, randomized trial assessing the safety and efficacy of intranasal plus topical mupirocin (Bactroban, GlaxoSmithKline; Centany, Medimetriks Pharmaceuticals Inc) in decolonizing SA in critically ill infants between April 2014 and May 2016.

S. aureus is a leading cause of sepsis in young children admitted to the NICU, and for infants, sepsis can prove fatal. Preventing such infections is extremely important for NICU babies, who are delicate and are often fighting multiple medical issues.

Infants in NICUs at eight study centers, aged younger than 24 months and colonized with SA, were randomly assigned to receive 5 days of mupirocin versus no mupirocin to the intranasal, periumbilical, and perianal areas. Treatment effects for all areas were evaluated on day 8 (primary decolonization) and day 22 (persistent decolonization). Primary decolonization occurred in 62/66 (93.9%) of treated infants and 3/64 (4.7%) of the control infants (P < 0.001). Persistent decolonization was seen in 21/46 (45.7%) of treated infants compared with 1/48 (2.1%) of the controls (P < 0.001).

Source:, January 3, 2019

Blood/Genetic Tests Can Identify Leukemia Risk in Newborns with Down Syndrome

Research into hundreds of babies with Down syndrome is providing valuable insight into leukemia’s genetic roots and offering a route to identify newborns at high risk.

A study by researchers at the University of Oxford’s MRC Weatherall Institute of Molecular Medicine identified children at high risk of developing myeloid leukemia within four years through blood or genetic tests.

Approximately 2%–3% of children with Down syndrome develop acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) at a far higher rate than that of the general population. In children aged 0–4 years with Down syndrome, AML’s standardized incidence ratio (SIR) is 114, compared with other children. The SIR of ALL is 27 in children aged 1–4 years.

The study recruited 471 neonates with Down syndrome and followed them for up to four years. One focus was on AML that appears before age 4 and is preceded by a neonatal preleukemia – transient abnormal myelopoiesis (TAM) – that only occurs in Down syndrome. TAM, which occurs with GATA1 mutations, usually resolves on its own after birth. But sometimes, the mutations continue, causing AML to develop.

The study showed that 341 of the children had no GATA1 mutation and 130 (28%) had the mutation. Dr. Irene Roberts of the MRC Weatherall Institute indicated that this latter number was a “very high frequency.”

In patients with the mutation, 7 (5%) developed AML at a median age of 16 months; no patient without the mutation developed AML. Among the 130 neonates with the mutation, 42% were considered to have “clinical” TAM and 58% were considered to have “silent” TAM. Researchers had predicted that babies with clinical TAM would have more severe disease, which turned out to be the case.

According to the study, newborns with Down syndrome are more likely to survive without leukemia if they have silent TAM, compared with those who have clinical TAM, and if they have an estimated variant allele frequency above 15%.

Source:, January 4, 2019

Vaxelis, a Pediatric 6-in-1 Vaccine, Receives FDA Approval

The FDA has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate [meningococcal protein conjugate] and hepatitis B [recombinant] vaccine), the first hexavalent vaccine available in the U.S.

Vaxelis, developed by Sanofi and Merck & Co., is for children aged 6 weeks through 4 years old to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to Haemophilus influenzae type B. The vaccine consists of a 0.5-mL intramuscular injection series administered to children before they turn 5 years old.

Vaxelis is contraindicated in children with a history of severe allergic reaction to a previous dose or any ingredient of Vaxelis, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type B vaccine.

The vaccine is also contraindicated in patients with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within seven days of a vaccine containing pertussis, which is not attributable to another identifiable cause, and in patients with a history of progressive neurologic disorder until a treatment regimen is established and the condition is stable.

Reported adverse reactions included irritability, crying, injection-site pain, somnolence, injection site erythema, decreased appetite, fever ≥ 38.0°C, injection-site swelling, and vomiting.

Merck and Sanofi are currently increasing supplies of Vaxelis to meet anticipated U.S. demand, and plan to launch the vaccine in 2020. The vaccine, which will be supplied in a single-dose vial in 10-count packages, was first approved in Europe in 2016.

Source:, January 2, 2019; Sanofi., December 26, 2018