A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19) has begun.

Gallbladder disease in children is an evolving entity and studies suggest an increasing frequency of symptomatic pediatric gallbladder disease and resultant cholecystectomies.

Hispanic ethnicity and obesity are epidemiologically significant risk factors for symptomatic gallbladder disease in the pediatric population. (Read the full article)

Clinical trials in children with severe traumatic brain injury (TBI) are challenging. To date, no work has been published that permits clinical investigators to estimate the number and compositional features of sites from which to recruit children with severe TBI into clinical trials.

Children with severe TBI are infrequent. Less than 5% of all US hospitals discharged more than 78% of severe TBI cases. To maximize enrollment efficiency for future clinical trials, attention has to be paid to selecting appropriate hospital sites. (Read the full article)

Available clinical prediction rules to identify children with cerebrospinal fluid pleocytosis at low risk for Lyme meningitis include headache duration, cranial nerve palsy, and percent cerebrospinal fluid mononuclear cells. These rules require independent validation.

These clinical prediction rules accurately identify patients at low risk for Lyme meningitis in our large multicenter cohort. Children at low risk may be considered for outpatient management while awaiting Lyme serology. (Read the full article)

The demographics of trials that use antenatal consent may not be representative of the populations that they are intended to study.

This study analyzes the difference in clinical outcomes between the enrolled and eligible but not enrolled populations of a trial that required antenatal consent. (Read the full article)

Few studies have examined the reliability of clinical findings in pediatric appendicitis. Clinical prediction rules are most useful if the included variables are reliable across practice settings and practitioners.

Among children who present with possible appendicitis, the interrater reliability varied considerably for patient history and physical examination variables. Those variables with the highest degree of reliability may be best suited for inclusion in appendicitis clinical prediction rules. (Read the full article)

Strategies to assist patients in achieving optimal chronic disease self-management are critical. The complex family and regimen issues surrounding pediatric type 1 diabetes management suggest the need to integrate such strategies into routine clinical care.

This study demonstrates the efficacy of a practical, low-intensity behavioral intervention delivered during routine care for improving glycemic outcomes. Findings indicate that the approach may offer a potential model for integrating medical and behavioral sciences to improve health care. (Read the full article)

Evaluating dehydration severity is a challenging task. Clinical dehydration scores that combine multiple clinical findings are promising. One clinical dehydration scale score has been developed and subsequently evaluated; however, few participants in the derivation and validation studies were significantly dehydrated.

In children requiring intravenous rehydration, the dehydration scale displayed moderate reliability and weak associations with objective measures. Thus, although the scale can assist in assessing dehydration, it should not be used in isolation to dictate interventions (eg, intravenous rehydration, hospitalization). (Read the full article)

Existing clinical research policy does not guarantee availability of results. Registration on the Web site ClinicalTrials.gov and the Food and Drug Administration Amendments Act improved transparency in pediatric clinical research. Registration and publication remain voluntary for many trials involving children.

Only 29% of completed registered studies and 53% of National Institutes of Health–funded trials involving children were published. Numbers of studies are increasing. Registration and posting of results on ClinicalTrials.gov should be mandatory for all studies involving children. (Read the full article)

Providers who speak Spanish, regardless of their proficiency level, may use Spanish for clinical care without seeking professional interpretation. Failure to use professional interpretation increases the risk for miscommunication and can lead to patient harm.

Providing residents with objective feedback on Spanish language proficiency decreased willingness to use Spanish in straightforward clinical scenarios. Language proficiency testing, coupled with institutional policies requiring professional interpretation, may improve care for patients with limited English proficiency. (Read the full article)

Persistent facial nerve palsy is a well-described neurologic deficit after Lyme neuroborreliosis and occurs in 13% to 20% of children. Other neurologic deficits are less closely described. Nonspecific subjective symptoms are reported as often among patients as controls in previous short-term follow-up studies.

Persistent neurologic deficits, other than facial nerve palsy, were found in 14% of patients, causing impaired fine motor skills, poor balance, or persistent pain. Nonspecific subjective symptoms were reported as often among patients as controls in this long-term follow-up study and should not be considered as sequelae after Lyme neuroborreliosis. (Read the full article)

There is evidence from both developed and developing countries that antiretroviral treatment significantly reduces mortality in HIV-infected children. However, in sub-Saharan Africa, numerous health system, financial, and human resource obstacles make delivering quality pediatric HIV care a challenge.

We describe the experience of the Baylor International Pediatrics AIDS Initiative in Malawi, Lesotho, and Swaziland. Despite challenges delivering pediatric treatment in these countries, mortality and clinical outcomes approaching those from developed countries are feasible. (Read the full article)

Critics argue that pediatric research without the potential for clinical benefit treats children as mere means to benefit others. Yet, there are no data to assess whether adolescents who participate in research, or their parents, agree with this view.

Respondents felt that by participating in research the adolescents were making important contributions to help others, and the adolescents felt proud to be doing so. These findings support the view that nonbeneficial pediatric research involves a type of charitable activity. (Read the full article)

There are limited data regarding the current status of the pediatric clinical trial enterprise.

Evaluation of the ClinicalTrials.gov data set allows description of the overall portfolio of clinical trials relevant to US children, which was previously not possible. (Read the full article)

Chromosomal microarray analysis offers a superior diagnostic yield over karyotyping for the evaluation of individuals with developmental disabilities. Many third-party payers, however, do not reimburse for microarray testing, citing a lack of evidence that patients benefit from testing.

This study demonstrates that microarray testing frequently identifies conditions that include features requiring specific medical follow-up and that referring physicians respond to abnormal test results with appropriate clinical actions. Microarray testing, therefore, provides direct benefits to patients. (Read the full article)

There is concern about the potential exploitation of children who are enrolled into clinical trials in developing and transition countries. Previous studies of globalization have only examined pediatric drug trials, and only 1 study has provided patient-level data by country.

The involvement of developing and transition countries depends on the product or indication under investigation and is greater for vaccines than for drugs or biologicals. Compared with our previous analysis, involvement of these countries in pediatric drug development has decreased. (Read the full article)

Gaining intravenous access in children can be difficult. Recently, several near-infrared devices have been introduced attempting to support intravenous cannulation by visualizing veins underneath skin. Only one of those devices has been evaluated systemically thus far and results are inconclusive.

Although it was possible to visualize veins with near-infrared in most patients, the VascuLuminator did not improve the success of cannulation. An explanation is that the main problem is probably not localization of the vein but insertion of the cannula. (Read the full article)

Cerebral edema (CE) occurs frequently during treatment of diabetic ketoacidosis (DKA) in children. Severe, life-threatening CE occurs rarely, but subclinical CE is common. Whether the rate of infusion of intravenous fluids influences the occurrence or severity of CE is unknown.

This study demonstrates that the rate of fluid infusion in children with DKA does not substantially affect MRI measures of CE. Studies assessing measures other than edema formation are necessary to determine whether fluid infusion rates influence DKA-related brain injury. (Read the full article)

Children exposed to second-hand smoke have high rates of hospitalization for respiratory illness. These visits represent a "teachable moment" when parental smokers can be motivated to quit. However, pediatric health care practitioners receive little training in tobacco cessation.

The Web-Based Respiratory Education About Tobacco and Health online training program was effective at increasing the provision of an effective tobacco cessation intervention by pediatric hospital-based respiratory therapists, registered nurses, and nurse practitioners to adult smokers. (Read the full article)

Pediatric training programs use simulation for procedural skills training. Research demonstrates student satisfaction with simulation training, improved confidence, and improved skills when retested on a simulator. Few studies, however, have investigated the clinical impact of simulation education.

This is the first multicenter, randomized trial to evaluate the impact of simulation-based mastery learning on clinical procedural performance in pediatrics. A single simulation-based training session was not sufficient to improve interns’ clinical procedural performance. (Read the full article)

Expectations are high that electronic health record–based clinical decision support and performance feedback will improve adherence to guidelines by delivering relevant and actionable information to clinicians. Few studies have evaluated these assertions or examined the combined effects of decision support and feedback.

Clinical decision support customized to a patient’s history and presentation and performance feedback are both effective for improving adherence to guidelines for otitis media. However, the combination of the 2 interventions is no better than either delivered alone. (Read the full article)

Neuropsychiatric conditions comprise a substantial and growing disease burden among children. Pharmacotherapy represents an important treatment option for these conditions, although most drugs are not approved for use in children.

Very few drug trials studying neuropsychiatric conditions focus on children. Furthermore, these trials examine and provide pediatric evidence for only a fraction of all available drugs in the treatment of common neuropsychiatric conditions. (Read the full article)

The ideal management of children with vesicoureteral reflux (VUR) remains a source of debate. There is little evidence to support many of the current management practices for children with VUR who have had 1 or 2 urinary tract infections.

Baseline associations, including bladder and bowel dysfunction and imaging studies, from the largest randomized, controlled trial conducted to date aimed at assessing the value of antimicrobial prophylaxis in children with urinary tract infection and VUR are presented. (Read the full article)

Asthma is a common medical complication during pregnancy that is associated with an increased risk of adverse obstetric outcomes.

This study adds knowledge on potential long-term consequences of maternal asthma during pregnancy for offspring health, demonstrating that maternal asthma during pregnancy is linked to a wide spectrum of offspring diseases during childhood. (Read the full article)

The intestinal microbiome may play a role in immune system maturation, and it has been postulated that early-life probiotic administration may reduce the risk of allergies and asthma in childhood. To date, however, results from clinical trials have been inconsistent.

In this meta-analysis, administration of probiotics in early life may reduce total immunoglobulin E level and protect against atopic sensitization but do not seem to protect against asthma/wheezing. Future trials should carefully select probiotic strains and include longer follow-up. (Read the full article)

Pediatric myasthenia encompasses a group of rare and underdiagnosed conditions affecting the neuromuscular junction. Symptoms include fluctuating skeletal muscle weakness, which can progress to respiratory failure if left untreated. The autoimmune form of this condition, in particular, is treatable.

This study describes the incidence, clinical features, diagnostic testing, and treatment trends of pediatric myasthenia in Canada, which have not been previously reported in the literature. (Read the full article)

Caregiver behavioral symptom ratings are frequently used to assist in diagnosing childhood behavioral disorders. Although behavioral disorders are highly comorbid with learning disabilities (LDs), little work has examined the utility of caregiver ratings of learning concerns for screening of comorbid LD.

The validity of a time- and cost-efficient caregiver rating of academic concerns (Colorado Learning Difficulties Questionnaire) was examined. The screening measure accurately predicted children without LD, suggesting that the absence of parent-reported difficulties may be adequate to rule out overt LD. (Read the full article)

Fewer clinical trials are performed in children compared with other patient populations. It is unknown how well existing pediatric clinical trials are aligned with the needs of children, both in high-income countries and globally.

There is only moderate correlation between clinical trial activity and pediatric burden of disease, with certain conditions substantially underrepresented in the current research portfolio. Our findings provide a benchmark for prioritizing conditions for study, analyzing gaps, and identifying funding priorities. (Read the full article)

Although appendicitis is the most common surgical cause of abdominal pain in pediatrics, its diagnosis remains elusive. When evaluated independently, clinical scoring systems and ultrasonography have been shown to have low to moderate sensitivity in the diagnosis of appendicitis.

Our study evaluated the accuracy of a clinical practice guideline combining the Samuel’s pediatric appendicitis score and selective ultrasonography as the primary imaging modality for children with suspected appendicitis. Our clinical pathway demonstrated high sensitivity and specificity. (Read the full article)

Quantitative real-time polymerase chain reaction allows sensitive detection of respiratory viruses. The clinical significance of detection of specific viruses is not fully understood, however, and several viruses have been detected in the respiratory tract of asymptomatic children.

Our results indicate that quantitative real-time polymerase chain reaction is limited at distinguishing acute infection from detection in asymptomatic children for rhinovirus, bocavirus, adenovirus, enterovirus, and coronavirus. (Read the full article)

The incidence of Kawasaki disease is increasing in many countries. The only reported Australian incidence (3.4/100 000 <5 years) is almost 20 years old and the current Australian epidemiology and outcomes are unknown.

We analyzed 30 years’ total population hospitalization data from Western Australia. Kawasaki disease incidence increased markedly from 1979 to 2009 and is currently 9.34/100 000 <5 years. The epidemiology and cardiovascular outcomes are similar to other predominantly European-Caucasian populations. (Read the full article)

Scabies is a frequent cause of consultation and has recently been classified as a neglected disease. The clinical presentation seems to be linked with age, although no specific study has aimed to delineate the clinical spectrum of scabies in infants and children.

Scabies in infants and children has distinct clinical features. This prospective observational study found that infants were more likely to have relapse, nodules, and to present involvement with extremities, face, and scalp, arguing for specific cares in this age group. (Read the full article)

Predicting high-risk populations in congenital diaphragmatic hernia (CDH) can help target care strategies. Prediction rules for infants with CDH often lack validation, are aimed at a prenatal population, and are of limited generalizability. We cannot currently discriminate the highest risk neonates during the crucial period shortly after birth.

This clinical prediction rule was developed and validated on an international database. It discriminates patients and high, intermediate, and low risk of mortality; is easy to apply; and is generalizable to most infants with CDH. (Read the full article)

There are discrepancies regarding which treatment is best in clinical practice for children with parapneumonic empyema, with some authors favoring video-assisted thoracoscopy and others favoring intrapleural fibrinolytic agents.

This study is one of the few randomized clinical trials on this subject in children and the first multicenter trial. It exclusively included patients with septated empyema. Thoracoscopy and fibrinolysis with urokinase were equally effective for this condition. (Read the full article)

Pediatric Brain Injury Research Network investigators recently derived a highly sensitive clinical prediction rule for pediatric abusive head trauma (AHT).

The performance of this AHT screening tool has been validated. Four clinical variables, readily available at the time of admission, detect pediatric AHT with high sensitivity in intensive care settings. (Read the full article)

Sustained lung inflation and positive end-expiratory pressure would permit lung recruitment immediately after birth, improving lung mechanics and reducing the need for respiratory support. Previous clinical studies in preterm infants provided promising results but have some limitations.

This randomized controlled study found that prophylactic sustained lung inflation and positive end-expiratory pressure in the delivery room decreased the need for mechanical ventilation in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome. (Read the full article)

Celiac disease (CD) may develop at any age. Young children with CD are at particular risk for malabsorption and failure to thrive. HLA-DR3-DQ2 homozygotes are at the highest genetic risk and develop CD very early in life.

Most children with CD detected in screening by 4 years of age have no symptoms and normal growth. Symptoms are unrelated to HLA genotype. Autoantibody levels correlate higher with severity of mucosal lesions in symptomatic as compared to asymptomatic children. (Read the full article)

Encephalitis is a serious and disabling condition. There are infectious and immune-mediated causes of encephalitis, but many cases remain undiagnosed.

This large single-center study on childhood encephalitis provides insight into the relative frequency and clinicoradiologic phenotypes of infectious, autoantibody-associated, and unknown encephalitis. Risk factors for an abnormal outcome are also defined. (Read the full article)

Conventional invasive pneumococcal disease (IPD) definition using laboratory confirmation lacks sensitivity. Using a vaccine-probe design, the FinIP trial showed that IPD disease burden and vaccine-preventable disease incidence were fourfold higher when a more sensitive outcome, clinically suspected IPD, was used.

Vaccine-preventable disease incidence (ie, absolute reduction due to PCV10 vaccination) during routine vaccination program was threefold with the more sensitive outcome of clinically suspected IPD compared with the conventional IPD definition. This has major implications for cost-effectiveness of PCVs. (Read the full article)

Central apnea sometimes complicates bronchiolitis. Because apnea tends to occur early in the course of bronchiolitis, there is a danger that infants may be discharged from the emergency department only to subsequently develop apnea at home.

This study prospectively derived clinical decision rules to help emergency physicians admit infants at risk for apnea while discharging those not at risk. (Read the full article)