Randomized trial to assess the efficacy and safety of xyloglucan for the treatment of acute gastroenteritis in children.

Acute gastroenteritis is one of the most common diseases in children and an important cause of morbidity and mortality worldwide. No specific treatment is available; therefore, management is exclusively symptomatic. Xyloglucan has been approved in Europe as a class IIa medical device for restoration of the physiological functions of the intestinal wall. Our objective was to assess efficacy and safety of xyloglucan for the treatment of acute gastroenteritis in children. We performed a triple-blind, randomized placebo-controlled clinical trial in four primary care centers and one continued care hospital center. The study population comprised children with acute gastroenteritis aged >3 months and <5 years. Our primary endpoint was time (in hours) of resolution of diarrhea, defined as the time to resolution of stool consistency (Bristol Stool Form Scale ≤5 or Amsterdam Stool Form Scale B or C) or time until deposition frequency resumes to normality, whichever occurred first. We also recorded intravenous rehydration, hospitalization, stools per day, Vesikari scale, vomiting, relapse, weight loss, drugs prescribed, and adverse events. Eighty children were included in the intention-to-treat population (43 xyloglucan and 37 placebo) and 74 (93%) in the per-protocol population. Time to resolution of diarrhea was similar in both groups with (median, 95% CI) 24, 17-24 h in the xyloglucan group versus 24, 19-24 h in the placebo group, p = .680. Significant differences were observed for patients with moderate-to-severe diarrhea (Vesikari scale ≥9): xyloglucan group (20 [15-24] h) versus placebo group (85 [51-120] h) (p = .04). No other significant differences were found. Xyloglucan can be considered safe and other studies should be performed to confirm the usefulness in patients with moderate-to-severe diarrhea.

Variability in the management of infants under 3 months with minor head injury in paediatric emergency departments.

INTRODUCTION: In the assessment of infants younger than 3 months with minor traumatic head injury (MHI), it is essential to adapt the indication of imaging tests. The Pediatric Head Injury/Trauma Algorithm (PECARN) clinical prediction rule is the most widely used to guide clinical decision making. OBJECTIVES: To analyse the variability in the performance of imaging tests in infants under 3 months with MHI in paediatric emergency departments (PEDs) and the adherence of each hospital to the recommendations of the PECARN rule. POPULATION AND METHODS: We conducted a prospective multicentre observational study in 13 paediatric emergency departments in Spain between May 2017 and November 2020. RESULTS: Of 21 981 children with MHI, 366 (1.7%) were aged less than 3 months; 195 (53.3%) underwent neuroimaging, with performance of CT scans in 37 (10.1%; interhospital range, 0%-40.0%), skull X-rays in 162 (44.3 %; range, 0%-100%) and transfontanellar ultrasound scans in 22 (6.0%; range, 0%-24.0%). The established recommendations were followed in 25.6% (10/39) of infants classified as high-risk based on PECARN criteria (range, 0%-100%); 37.1% (36/97) classified as intermediate-risk (range, 0%-100%) and 57.4% (132/230) classified as low-risk (range, 0%-100%). CONCLUSION: We found substantial variability and low adherence to the PECARN recommendations in the performance of imaging tests in infants aged less than 3 months with MHI in Spanish PEDs, mainly due to an excessive use of skull X-rays.

Variabilidad en la atención en urgencias al lactante menor de 3 meses con un traumatismo craneoencefálico leve / Variability in the management of infants under 3 months with minor head injury in paediatric emergency departments

Introducción: En la valoración de los lactantes menores de 3 meses con un traumatismo craneoencefálico (TCE) leve es imprescindible adecuar la indicación de pruebas radiológicas. La regla de predicción clínica PECARN es la más utilizada para ayudar en la toma de decisiones clínicas. Objetivos: Evaluar la variabilidad en la realización de pruebas radiológicas en los menores de 3 meses con un TCE leve en los servicios de urgencias pediátricos y la adherencia de cada hospital a las recomendaciones de la regla de predicción clínica PECARN. Población y métodos: Estudio de cohortes prospectivo en<3 meses con un TCE leve que consultaron en 13 servicios de urgencias pediátricos españoles entre mayo de 2017 y noviembre de 2020. Resultados: Se atendieron 21.981 pacientes con un TCE leve, de los que 366 (1,7%) eran menores de 3 meses. Se realizaron pruebas de imagen al 53,3% (195): TC craneal a 37 (10,1% [rango entre hospitales 0-40%]), radiografía de cráneo a 162 (44,3% [rango 0-100%]) y ecografía transfontanelar a 22 (6,0% [rango 0-24%]). Se siguieron las recomendaciones PECARN en el 25,6% (10/39) de los lactantes con criterios de alto riesgo (rango 0-100%); el 37,1% (36/97) de los de riesgo intermedio (rango 0-100%) y el 57,4% (132/230) de los de bajo riesgo (rango 0-100%). Conclusiones: Existe gran variabilidad, con un bajo cumplimiento de las recomendaciones PECARN, en la realización de pruebas radiológicas en los menores de 3 meses que consultan por un TCE leve en los servicios de urgencias pediátricos españoles, a expensas fundamentalmente de un exceso en el empleo de radiografías de cráneo. (AU)

Introduction: In the assessment of infants younger than 3 months with minor traumatic head injury (MHI), it is essential to adapt the indication of imaging tests. The Pediatric Head Injury/Trauma Algorithm (PECARN) clinical prediction rule is the most widely used to guide clinical decision making. Objectives: To analyse the variability in the performance of imaging tests in infants under 3 months with MHI in paediatric emergency departments and the adherence of each hospital to the recommendations of the PECARN rule. Population and methods: We conducted a prospective multicentre observational study in 13 paediatric emergency departments in Spain between May 2017 and November 2020. Results: Of 21,981 children with MHI, 366 (1.7%) were aged less than 3 months; 195 (53.3%) underwent neuroimaging, with performance of CT scans in 37 (10.1%; interhospital range, 0%–40.0%), skull X-rays in 162 (44.3%; range, 0%–100%) and transfontanellar ultrasound scans in 22 (6.0%; range, 0%–24.0%). The established recommendations were followed in 25.6% (10/39) of infants classified as high-risk based on PECARN criteria (range, 0%–100%); 37.1% (36/97) classified as intermediate-risk (range, 0%–100%) and 57.4% (132/230) classified as low-risk (range, 0%–100%). Conclusion: We found substantial variability and low adherence to the PECARN recommendations in the performance of imaging tests in infants aged less than 3 months with MHI in Spanish paediatric emergency departments s, mainly due to an excessive use of skull X-rays. (AU)

Evaluation of the PECARN rule for traumatic brain injury applied to infants younger than 3 months and creation of a modified, age-specific rule.

Infants < 3 months with minor head trauma (MHT) are a particularly vulnerable group, though few studies have focused specifically on these patients. We aimed to evaluate the application of the PECARN prediction rule, designed for clinically important traumatic brain injury (ciTBI) in children < 2 years in infants < 3 months, and create a specific prediction rule for this population. We conducted a prospective multicenter observational study in 13 pediatric emergency departments (PEDs) in Spain. The PECARN rule was applied to all patients. A new specific prediction rule for infants < 3 months of age was created. The main outcome measures were (1) ciTBI, (2) TBI evidenced on computed tomography (CT) scan, and (3) isolated skull fracture (ISF). Telephone follow-up was conducted for all patients over the 4 weeks after the initial PED visit. Of 21,981 children with MHT, 366 (1.7%) were < 3 months old and 195 (53.3%) underwent neuroimaging, including 37 (10.1%) with CT scan. The sensitivity and negative predictive value (NPV) of the PECARN prediction rule for ciTBI were 100% (95% CI, 20.7-100) and 99.7% (95% CI, 98.4-100%), respectively. Of the 230 infants (62.8%) who met the PECARN low-risk criteria, none had ciTBI, 1 (0.4% overall, 95% CI, 0-2.4) had TBI on CT, and 2 (0.9% overall; 95% CI, 0.1-3.1) had an ISF. Among the 136 infants (37.2%) who did not meet the PECARN low-risk criteria, 1 (0.3% overall; 95% CI, 0-1.5) had ciTBI, 11 (8.1% overall; 95% CI, 4.1-14.0) had TBI on CT, and 18 (13.2% overall; 95% CI, 8-20.1) had an ISF. The sensitivity and NPV of the Spanish prediction rule for ciTBI were 100% (95% CI, 20.7-100) and 100% (95% CI, 98.4-100%), respectively. No infants in the registry developed complications during follow-up. CONCLUSION: The PECARN rule for infants < 2 years old accurately identified infants < 3 months old at low risk for ciTBI in our population, although the adapted Spanish rule presented here could be even more accurate. WHAT IS KNOWN: • Infants younger than 3 months are vulnerable to minor blunt head trauma due to their age and to difficulties in assessing the subtle symptoms and minimal physical findings detected on examination. • A low threshold for CT scan is recommended in this population. WHAT IS NEW: • PECARN rule for infants < 2 years old is an adequate tool with which to identify infants < 3 months old at low risk for clinically important traumatic brain injury. • Spanish rule could identify even more low-risk infants without overlooking important outcomes but it should be validated to confirm its predictive capacity.

Epidemiology of minor blunt head trauma in infants younger than 3 months.

Specific knowledge of the features of minor head trauma in infants is necessary to develop appropriate preventive strategies and adjust clinical management in pediatric emergency departments (PEDs). The aim of this study is to describe the epidemiology of minor blunt head trauma in infants < 3 months who present to PEDs. We performed a prospective study of infants evaluated in any of 13 Spanish PEDs within 24 h of a minor head trauma (Glasgow Coma Scale scores of 14-15) between May 2017 and November 2020. Telephone follow-up was conducted for all patients over the 4 weeks after the initial PED visit. Of 1,150,255 visits recorded, 21,981 children (1.9%) sustained a head injury, 386 of whom (0.03%) were under 3 months old. Among the 369 patients who met the inclusion criteria (0.03%), 206 (56.3%) were male. The main causes of trauma were fall-related (298; 80.8%), either from furniture (138/298; 46.3%), strollers (92/298; 30.9%), or a caregiver's arms (61/298; 20.5%). Most infants were asymptomatic (317; 85.9%) and showed no signs of injury on physical exam (210; 56.9%). Imaging studies were performed in 195 patients (52.8%): 37 (10.0%) underwent computed tomography (CT) scan, 162 (43.9%) X-ray, and 22 (6.0%) ultrasound. A clinically important traumatic brain injury (ciTBI) occurred in 1 infant (0.3% overall; 95% CI, 0-1.5), TBI was evidenced on CT scan in 12 (3.3% overall; 95% CI, 1.7-5.7), and 20 infants had an isolated skull fracture (5.5% overall; 95% CI, 3.4-8.3). All outcomes were caused by falls onto hard surfaces. CONCLUSION:  Most head injuries in infants younger than 3 months are benign, and the rate of ciTBI is low. Prevention strategies should focus on falls onto hard surfaces from furniture, strollers, and caregivers' arms. Optimizing imaging studies should be a priority in this population. WHAT IS KNOWN: • Infants younger than 3 months are vulnerable to minor blunt head trauma due to their age and to difficulties in assessing the subtle symptoms and minimal physical findings detected on examination. • A low threshold for CT scan is recommended in this population. WHAT IS NEW: • Most cases of blunt head trauma in infants younger than 3 months have good outcomes, and the rate of clinically important traumatic brain injury is low. • Optimizing imaging studies should be a priority in this population, avoiding X-ray examinations and reducing unnecessary CT scans.

Unexpected diagnosis of severe coarctation of the aorta after ketamine procedural sedation.

A 12-year-old child presented to the emergency department with a right forearm fracture. After administration of an intravenous dose of ketamine for fracture reduction, he developed severe hypertension. This sign led us to discover an undiagnosed coarctation of the aorta.