random Pulse Oximeter Sensor Application During Neonatal Resuscitation: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-02-17T00:07:18-08:00 Pulse oximeter is better than skin color assessment in the initial minutes of life. After sensor application, a delay occurs in the display of reliable saturation and heart rate. An appropriate method of sensor placement can minimize the delay.Attaching sensor first to oximeter and then to neonate picked up signal faster than attaching it to the neonate first and then to the equipment. However, the time from birth to display of reliable signal was similar between the methods. (Read the full article) Full Article
random Effective Messages in Vaccine Promotion: A Randomized Trial By pediatrics.aappublications.org Published On :: 2014-03-03T00:06:29-08:00 Maintaining high levels of measles-mumps-rubella immunization is an important public health priority that has been threatened by discredited claims about the safety of the vaccine. Relatively little is known about what messages are effective in overcoming parental reluctance to vaccinate.Pro-vaccine messages do not always work as intended. The effectiveness of those messages may vary depending on existing parental attitudes toward vaccines. For some parents, they may actually increase misperceptions or reduce vaccination intention. (Read the full article) Full Article
random Diarrhea in Preschool Children and Lactobacillus reuteri: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-03-17T00:06:43-07:00 Diarrhea still remains as a significant cause of morbidity and mortality. Intervention to reduce this risk are needed. Evidence on the effect of Lactobacillus reuteri DSM 17938 to prevent diarrhea in children is scarce.In healthy children attending day care centers, daily administration of L reuteri DSM 17938 had a significant effect in reducing episodes and duration of diarrhea and respiratory tract infections, with consequent cost saving for the community. (Read the full article) Full Article
random Collaborative Care Outcomes for Pediatric Behavioral Health Problems: A Cluster Randomized Trial By pediatrics.aappublications.org Published On :: 2014-03-24T00:06:20-07:00 Integrated or collaborative care intervention models have revealed gains in provider care processes and outcomes in adult, child, and adolescent populations with mental health disorders. However optimistic, conclusions are not definitive due to methodologic limitations and a dearth of studies.This randomized trial provides further evidence for the efficacy of an on-site intervention (Doctor Office Collaborative Care) coordinated by care managers for children's behavior problems. The findings provide support for integrated behavioral health care using novel provider and caregiver outcomes. (Read the full article) Full Article
random Practice-Tailored Facilitation to Improve Pediatric Preventive Care Delivery: A Randomized Trial By pediatrics.aappublications.org Published On :: 2014-05-05T00:06:52-07:00 Children receive only half of recommended health care; disadvantaged children have higher risk of unmet needs. Practice coaching combined with quality improvement using rapid-cycle feedback has potential to help practices meet quality standards and improve pediatric health care delivery.The Practice-tailored Facilitation Intervention led to large and sustained improvements in preventive service delivery, including substantial numbers of disadvantaged children, and in multiple simultaneous health care domains. Practice-tailored facilitation holds promise as a method to advance pediatric preventive care delivery. (Read the full article) Full Article
random Cognitive Outcomes of Preterm Infants Randomized to Darbepoetin, Erythropoietin, or Placebo By pediatrics.aappublications.org Published On :: 2014-05-12T00:06:52-07:00 Although a number of randomized controlled trials of erythropoietin administration to preterm infants have been performed, few studies have reported 2-year or longer neurodevelopmental outcomes, and no studies have evaluated neurodevelopmental outcomes of infants randomized to receive Darbepoetin.This is the first prospectively designed study to evaluate the neurocognitive outcomes of preterm infants randomized to receive Darbepoetin or erythropoietin compared with placebo. Infants in the ESA groups had significantly higher cognitive scores compared with the placebo group. (Read the full article) Full Article
random Increasing Provision of Adolescent Vaccines in Primary Care: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-07-07T05:07:02-07:00 The Centers for Disease Control and Prevention recommends that health departments in all 50 states deliver AFIX (Assessment, Feedback, Incentives, and eXchange) consultations to 25% of federally funded vaccine providers each year. AFIX effectively raises vaccination coverage among young children.AFIX consultations achieved short-term gains in coverage for 11- to 12-year-olds for vaccines in the adolescent platform. No gains occurred for older adolescents or over the long term. Consultations were equally effective when delivered in-person or by webinar. (Read the full article) Full Article
random Weighted Blankets and Sleep in Autistic Children--A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-07-14T00:07:16-07:00 Children with autism sleep poorly compared with their peers. Sensory integration, including use of weighted blankets, is proposed as a means to reduce arousal and stress. There is, however, no evidence that weighted blankets can improve sleep for these children.This is the first robust study to evaluate the impact of weighted blankets and show that they do not improve sleep parameters in children with autism spectrum disorder. (Read the full article) Full Article
random Reducing Distress in Mothers of Children With Autism and Other Disabilities: A Randomized Trial By pediatrics.aappublications.org Published On :: 2014-07-21T00:07:03-07:00 Mothers of children with neurodevelopmental disabilities often experience poor health, high stress, anxiety, and depression. Highly stressed parents are less effective in their parenting roles, risking their children's developmental progress.Evidence-based interventions in mindfulness and positive psychology significantly reduce distress in mothers of children with disabilities. Well-trained peer-mentors are effective interventionists. Adult-oriented services are needed for these mothers to improve their mental health and sustain their caregiving over the long-term. (Read the full article) Full Article
random Telephone Peer Counseling of Breastfeeding Among WIC Participants: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-08-04T00:06:57-07:00 In-person peer counseling to pregnant and new mothers has been shown to improve breastfeeding modestly in three US RCTs. But this level of support for WIC is unlikely to be scaled up nationally in the current fiscal environment.We randomly assigned WIC clients to a telephone peer counseling program relative to standard WIC support for breastfeeding. Nonexclusive breastfeeding among Spanish-speakers increased at 1, 3, and 6 months, but the program had much less of an effect on English-speaking clients. (Read the full article) Full Article
random Automated Conversation System Before Pediatric Primary Care Visits: A Randomized Trial By pediatrics.aappublications.org Published On :: 2014-08-04T00:06:56-07:00 A substantial gap exists between what is recommended for effective primary care of children and what takes place. Patient-centered health information technologies have been used to gather information and counsel parents, however, have not been integrated directly with electronic health records nor been speech-based to improve decision-making at the point-of-care.This study shows that a ubiquitous technology, the telephone, can be successfully used to automatically assess and counsel parents before pediatric primary care visits as well as inform their primary care clinicians in a way that is feasible and effective for multiple important issues. (Read the full article) Full Article
random High-dose Vitamin A With Vaccination After 6 Months of Age: A Randomized Trial By pediatrics.aappublications.org Published On :: 2014-08-18T00:07:03-07:00 The World Health Organization recommends using vaccination contacts to deliver high-dose vitamin A supplementation (VAS) to children aged 6 to 59 months. The effect of this policy on overall child mortality has not been assessed.In this first randomized controlled trial of VAS at routine vaccination contacts after 6 months, VAS had no overall effect on mortality but was associated with reduced mortality in girls and increased mortality in boys. (Read the full article) Full Article
random Adoption of Cardiovascular Risk Reduction Guidelines: A Cluster-Randomized Trial By pediatrics.aappublications.org Published On :: 2014-08-25T00:07:25-07:00 Cardiovascular risk begins in childhood. New clinical guidelines established a care strategy for lowering risks. Incorporation of guidelines into routine practice lags due to barriers related to knowledge and attitudes about guidelines, as well as behaviors of practitioners, patients, and clinical systems.This study demonstrated that a multifaceted approach including tools, education, and support for changes in practice systems can accelerate the adoption of guidelines during routine pediatric well-child visits, compared with dissemination of the guidelines alone. (Read the full article) Full Article
random Effects of the FITKids Randomized Controlled Trial on Executive Control and Brain Function By pediatrics.aappublications.org Published On :: 2014-09-29T00:06:48-07:00 Physical activity programs have been shown to have positive implications for children’s cognitive performance and brain structure and function. However, additional randomized controlled trials are needed to determine whether daily physical activity influences executive control and its neural underpinnings.The randomized controlled trial, designed to meet daily physical activity recommendations, used behavioral and electrophysiological measures of brain function to demonstrate enhanced attentional inhibition and cognitive flexibility among prepubertal children. (Read the full article) Full Article
random Feedback on Oral Presentations During Pediatric Clerkships: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-10-27T00:06:33-07:00 Delivering competent oral case presentations is an important clinical communication skill, yet effective means of improving trainees’ presentations have not been identified.Oral presentation feedback sessions facilitated by faculty by using an 18-item competency-based evaluation form early in pediatric clerkships improved medical students’ subsequent oral presentations. Medical schools should consider implementing this evidence-supported practice. (Read the full article) Full Article
random Urokinase Versus VATS for Treatment of Empyema: A Randomized Multicenter Clinical Trial By pediatrics.aappublications.org Published On :: 2014-10-27T00:06:34-07:00 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) Full Article
random A Randomized Trial on Screening for Social Determinants of Health: the iScreen Study By pediatrics.aappublications.org Published On :: 2014-11-03T00:06:30-08:00 Despite growing interest around clinical screening for health-related social and environmental risk factors, little evidence exists regarding screening formats that maximize disclosure of psychosocial information.This study compares psychosocial and socioeconomic adversity disclosure rates in face-to-face interviews versus electronic formats in a large, urban pediatric emergency department. (Read the full article) Full Article
random Coparenting Breastfeeding Support and Exclusive Breastfeeding: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-12-01T00:06:28-08:00 Fathers’ attitude and support affects breastfeeding outcomes. Fathers are currently not targeted in breastfeeding support and care provided by health care professionals. Breastfeeding interventions delivered to fathers have been shown to increase breastfeeding exclusivity and duration.A coparenting breastfeeding support intervention delivered to mothers and fathers in the postpartum period showed beneficial effects on breastfeeding duration, paternal breastfeeding confidence, breastfeeding help provided by fathers, and mothers’ satisfaction with fathers’ involvement with breastfeeding. (Read the full article) Full Article
random Text Message Reminders for Second Dose of Influenza Vaccine: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2014-12-29T00:06:47-08:00 Influenza vaccine coverage is low, and young children in need of 2 doses in a given season are at particular risk, with less than half receiving both doses. Text message vaccine reminders increase receipt of first dose of influenza vaccine.Little is known about what types of text message reminders are most effective, including embedding educational information. We demonstrate that text message reminders increase timely receipt of the second dose of influenza vaccine and embedding health literacy information improves effectiveness. (Read the full article) Full Article
random Benefits of Strict Rest After Acute Concussion: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-01-05T00:06:55-08:00 Expert consensus recommends rest after concussion with stepwise return to activity. Animal and retrospective human data suggest that early mental and physical activity may worsen outcome. There are no pediatric studies testing the efficacy of recommending strict rest after concussion.Recommending strict rest postinjury did not improve outcome and may have contributed to increased symptom reporting. Usual care (rest for 1–2 days with stepwise return to activity) is currently the best discharge strategy for pediatric mild traumatic brain injury/concussion. (Read the full article) Full Article
random Online Problem-Solving Therapy After Traumatic Brain Injury: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-01-12T00:05:27-08:00 Pediatric traumatic brain injury (TBI) contributes to impairments in functioning across multiple settings. Online family problem-solving therapy may be effective in reducing adolescent behavioral morbidity after TBI. However, less is known regarding maintenance of effects over time.This large randomized clinical trial in adolescents with TBI is the only study to examine maintenance of treatment effects. Findings reveal that brief, online treatment may result in long-term improvements in child functioning, particularly among families of lower socioeconomic status. (Read the full article) Full Article
random Morphine or Ibuprofen for Post-Tonsillectomy Analgesia: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-01-26T00:05:28-08:00 Sleep apnea is a common condition in childhood, mainly managed by tonsillectomy. Codeine was recently contraindicated for pain management after surgery. Controversy exists regarding the safety and effectiveness of alternative medications, morphine, and ibuprofen.Our findings suggest that ibuprofen does not increase tonsillar bleeding and in combination with acetaminophen is effective for pain management after tonsillectomy. Furthermore, standard morphine doses increased postoperative respiratory events and were not safe in all children. (Read the full article) Full Article
random Sustained Lung Inflation at Birth for Preterm Infants: A Randomized Clinical Trial By pediatrics.aappublications.org Published On :: 2015-01-26T00:05:27-08:00 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) Full Article
random A School-Based Sleep Education Program for Adolescents: A Cluster Randomized Trial By pediatrics.aappublications.org Published On :: 2015-02-16T00:05:27-08:00 Sleep deprivation is a worldwide problem in adolescents. The effectiveness of sleep education in enhancing sleep knowledge with consequent modification of sleep habits remains uncertain, in view of small sample sizes and lack of control groups in previous studies.This large-scale, cluster randomized controlled study found that a school-based sleep education program was effective in enhancing sleep knowledge and improving behavioral and mental health, but it had no significant impact on sleep duration or pattern among adolescents. (Read the full article) Full Article
random Early Intervention for Toddlers With Language Delays: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-03-02T00:05:24-08:00 Early language delay is common in toddlers and is associated with poor academic outcomes, reading difficulties, and persistent communication problems. Despite these long-term sequelae, few interventions for toddlers with early language delays yield positive expressive and receptive language results.A 28-session program delivered over 3 months can enhance parent language facilitation strategies. Unusually, the small short-term benefits were mainly in receptive, rather than expressive, language and vocabulary. Extended follow-up could determine the costs versus benefits of this promising approach. (Read the full article) Full Article
random Safety and Efficacy of Pimecrolimus in Atopic Dermatitis: A 5-Year Randomized Trial By pediatrics.aappublications.org Published On :: 2015-03-23T00:05:26-07:00 Topical corticosteroids are often used to treat atopic dermatitis (AD) in infants, although compliance is poor due to concerns over side effects. Pimecrolimus was shown to be a safe and effective noncorticosteroid treatment of AD in infants in short-term studies.The Petite Study shows that long-term management of mild-to-moderate AD in infants with pimecrolimus or topical corticosteroids was safe without any effect on the developing immune system. Pimecrolimus had similar efficacy to topical corticosteroids and a marked steroid-sparing effect. (Read the full article) Full Article
random Vitamin B-12, Folic Acid, and Growth in 6- to 30-Month-Old Children: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-03-23T00:05:25-07:00 Micronutrient deficiencies, including deficiencies of vitamin B-12 and folate, are common worldwide and may be a contributing factor to the estimated 165 million stunted children.Routine supplementation of vitamin B-12 improved linear and ponderal growth in subgroups of young Indian children. We provide evidence that vitamin B-12 deficiency is a contributor to poor growth in low- and middle-income countries. (Read the full article) Full Article
random Collaborative Care for Children With ADHD Symptoms: A Randomized Comparative Effectiveness Trial By pediatrics.aappublications.org Published On :: 2015-03-23T00:05:24-07:00 Collaborative care is known to be an effective system to manage child behavioral health conditions in the primary care setting.Among urban children with attention-deficit/hyperactivity disorder, using lay care managers to address barriers to engagement with care and challenging child behaviors has the potential to improve the effectiveness of conventional collaborative care. (Read the full article) Full Article
random Medical-Legal Strategies to Improve Infant Health Care: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-06-01T06:07:56-07:00 US parents trust the health care system and bring their infant children in for preventive care. Previous studies have demonstrated the ability of health care systems to identify, and sometimes address, the economic needs of low-income families.Families of newborns at a safety-net primary care center have high levels of economic hardship. Compared with controls, Developmental Understanding and Legal Collaboration for Everyone families had accelerated access to concrete supports, improved rates of on-time immunization and preventive care, and decreased emergency department utilization. (Read the full article) Full Article
random Physician Communication Training and Parental Vaccine Hesitancy: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-06-01T06:07:55-07:00 Parental hesitancy about childhood vaccines is prevalent and related to delay or refusal of immunizations. Physicians are highly influential in parental vaccine decision-making, but may lack confidence in addressing parents’ vaccine concerns.A physician-targeted communications intervention designed to reduce maternal vaccine hesitancy through the parent-physician relationship did not affect maternal hesitancy or physician confidence communicating with parents. Further research should determine the most effective approaches to addressing vaccine hesitancy. (Read the full article) Full Article
random Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial By pediatrics.aappublications.org Published On :: 2015-07-06T00:06:48-07:00 More than 200 million children <5 years are not reaching their developmental potential. Lack of stimulating caregiving is a major cause, and effective scalable interventions are needed. Integrating parenting with health services has been recommended, but there are few evaluations.An innovative parenting intervention can be delivered at routine visits for primary health care, with benefits to child cognitive development and parenting knowledge. This approach using films, discussion, and practice has the potential for delivery at scale. (Read the full article) Full Article
random A Tailored Family-Based Obesity Intervention: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-07-20T00:07:27-07:00 Although treatment programs for childhood obesity can demonstrate success, long-term outcomes have seldom been evaluated. The benefit of intervention when overweight is identified in a screening assessment and parental recognition of the problem is minimal is understudied.A low-dose (sessions every 1–3 months), but long-term (2 years), family-based intervention was effective at reducing BMI compared with usual care in children recruited via a weight screening initiative in which many parents had been unaware their child was overweight. (Read the full article) Full Article
random The Impact of Rudeness on Medical Team Performance: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-08-10T00:07:44-07:00 Rudeness is routinely experienced by hospital-based medical teams. Individuals exposed to mildly rude behavior perform poorly on cognitive tasks, exhibit reduced creativity and flexibility, and are less helpful and prosocial.Rudeness had adverse consequences on diagnostic and procedural performance of members of the NICU medical teams. Information-sharing mediated the adverse effect of rudeness on diagnostic performance, and help-seeking mediated the effect of rudeness on procedural performance. (Read the full article) Full Article
random Alcohol Interventions Among Underage Drinkers in the ED: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-09-07T00:07:55-07:00 Intervention strategies are needed to reduce underage drinking. Meta-analyses of youth alcohol brief interventions (BIs) conclude that therapist-delivered BIs are efficacious; however, to maximize public health impact, recommendations include using technology to streamline intervention delivery, for which evidence is lacking.A single-session BI, delivered by a computer or therapist in the emergency department, shows promise for underage drinkers. Findings for the stand-alone computer BI are particularly appealing given the ease of future implementation. (Read the full article) Full Article
random Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-09-28T00:07:30-07:00 The vitamin D concentration in breast milk of women taking 400 IU vitamin D per day is relatively low, leading to vitamin D deficiency in breastfeeding infants. As a result, the American Academy of Pediatrics recommends breastfeeding infant vitamin D supplementation within days after birth.Maternal vitamin D supplementation alone with 6400 IU/day safely supplies breast milk with adequate vitamin D to satisfy the requirement of her nursing infant and offers an alternate strategy to direct infant supplementation. (Read the full article) Full Article
random Intraurethral Lidocaine for Urethral Catheterization in Children: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-09-28T00:07:30-07:00 Urethral catheterization is a painful, yet common procedure to obtain a sterile urine sample in young children. There are conflicting results regarding the effectiveness of lidocaine to reduce pain, and it is unclear if it should be routinely used.In young children, combined topical and intraurethral lidocaine does not reduce pain during urethral catheterization and is associated with more pain than nonanesthetic lubricant during instillation. Clinicians should use noninvasive methods of analgesia during this painful procedure. (Read the full article) Full Article
random Deferred Consent for Randomized Controlled Trials in Emergency Care Settings By pediatrics.aappublications.org Published On :: 2015-10-05T00:07:46-07:00 Deferral of consent avoids delaying emergency interventions while ensuring consent to ongoing participation and use of data. Deferred consent is particularly important for enabling trials in pediatric settings, where many medicines and devices are unlicensed and untested for use.Approaches for seeking deferred consent should balance the potential burden of obtaining consent against risk of bias due to outcome-related attrition. Ethics committees could consider approving data use when best efforts to obtain deferred consent are met with no response. (Read the full article) Full Article
random Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-10-19T00:07:48-07:00 Endotracheal intubation is a mandatory skill for neonatal trainees. It is a difficult skill to acquire, and success rates of junior doctors are low and falling.Videolaryngoscopy allows the supervisor to share the intubator’s view of the airway and provide more informed guidance. Teaching intubation using a videolaryngoscope with the screen visible to the instructor results in significantly higher success rates for inexperienced doctors. (Read the full article) Full Article
random Promoting HPV Vaccination in Safety-Net Clinics: A Randomized Trial By pediatrics.aappublications.org Published On :: 2015-10-19T00:07:48-07:00 Previous studies have evaluated separately the effects of brief education and reminder/recall intervention strategies to increase human papillomavirus vaccine coverage. None have examined if intervention effects varied by race/ethnicity.When compared with a general adolescent vaccine brochure, human papillomavirus vaccine-specific educational materials increased 1-dose coverage among Hispanic but not black individuals. Recalls for doses 2 and 3 were effective in increasing 3-dose coverage for both racial/ethnic groups. (Read the full article) Full Article
random Treating EEG Seizures in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-10-19T00:07:47-07:00 Continuous conventional EEG video is currently gold standard for identifying neonatal seizures and a substantial proportion of neonatal seizures are electrographic. Currently there is no direct evidence that EEG monitoring, seizure identification, or treatment impacts long-term outcomes.In neonates with hypoxic ischemic encephalopathy, EEG monitoring and treatment of electrographic seizures results in significant reduction in seizure burden. Increasing seizure burden is associated with more severe brain injury and significantly lower performance scores on Bayley Scales of Infant Development III. (Read the full article) Full Article
random Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2015-10-26T00:07:20-07:00 The impact of neonatal abstinence syndrome is of concern because the number of newborns showing symptoms of withdrawal after intrauterine drug exposure is increasing worldwide. Newborns developing neonatal abstinence syndrome require prolonged medical treatment and longer hospital admission after birth.This first randomized controlled trial presents data on newborns with neonatal abstinence syndrome treated with laser acupuncture. The findings suggest that adjuvant laser acupuncture has the potential to reduce duration of morphine therapy and length of hospital stay. (Read the full article) Full Article
random Evaluation of the effect of contezolid (MRX-I) on the corrected QTc interval: a randomized, double-blind, placebo- and positive-controlled crossover study in healthy Chinese volunteers [Clinical Therapeutics] By aac.asm.org Published On :: 2020-03-30T10:04:32-07:00 Contezolid (MRX-I), a new oxazolidinone, is an antibiotic in development for treating complicated skin and soft tissue infections (cSSTI) caused by resistant Gram-positive bacteria. This was a thorough QT study conducted in 52 healthy subjects who were administered oral contezolid at a therapeutic (800 mg) dose, a supratherapeutic (1600 mg) dose, placebo, and oral moxifloxacin 400 mg in 4 separate treatment periods. The pharmacokinetic profile of contezolid was also evaluated. Time-point analysis indicated that the upper bounds of the two-sided 90% confidence interval (CI) for placebo-corrected change-from-baseline QTc (QTc) were <10 ms for the contezolid therapeutic dose at each time point. The upper bound of the 90% CI for QTc were slightly more than 10 ms with the contezolid supratherapeutic dose at 3 and 4 hours postdose, and the prolongation effect on the QT/QTc interval was less than that of the positive control, moxifloxacin 400 mg. At 3 and 4 h after the moxifloxacin dose, the moxifloxacin group met the assay sensitivity criteria outlined in ICH Guidance E14 with having a lower confidence bound ≥5 ms. The results of a linear exposure-response model which were similar to that of a time point analysis demonstrated a slightly positive relationship between contezolid plasma levels and QTcF interval with a slope of 0.227 ms per mg/L (90% CI: 0.188 to 0.266). In summary, contezolid did not prolong the QT interval at a therapeutic dose and may have a slight effect on QT interval prolongation at a supratherapeutic dose. Full Article
random Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial By pediatrics.aappublications.org Published On :: 2020-04-01T01:00:57-07:00 BACKGROUND: Approximately 25% of children with concussion have persistent postconcussive symptoms (PPCS) with resultant significant impacts on quality of life. Melatonin has significant neuroprotective properties, and promising preclinical data suggest its potential to improve outcomes after traumatic brain injury. We hypothesized that treatment with melatonin would result in a greater decrease in PPCS symptoms when compared with a placebo. METHODS: We conducted a randomized, double-blind trial of 3 or 10 mg of melatonin compared with a placebo (NCT01874847). We included youth (ages 8–18 years) with PPCS at 4 to 6 weeks after mild traumatic brain injury. Those with significant medical or psychiatric histories or a previous concussion within the last 3 months were excluded. The primary outcome was change in the total youth self-reported Post-Concussion Symptom Inventory score measured after 28 days of treatment. Secondary outcomes included change in health-related quality of life, cognition, and sleep. RESULTS: Ninety-nine children (mean age: 13.8 years; SD = 2.6 years; 58% girls) were randomly assigned. Symptoms improved over time with a median Post-Concussion Symptom Inventory change score of –21 (95% confidence interval [CI]: –16 to –27). There was no significant effect of melatonin when compared with a placebo in the intention-to-treat analysis (3 mg melatonin, –2 [95% CI: –13 to 6]; 10 mg melatonin, 4 [95% CI: –7 to 14]). No significant group differences in secondary outcomes were observed. Side effects were mild and similar to the placebo. CONCLUSIONS: Children with PPCS had significant impairment in their quality of life. Seventy-eight percent demonstrated significant recovery between 1 and 3 months postinjury. This clinical trial does not support the use of melatonin for the treatment of pediatric PPCS. Full Article
random Randomized Placebo-controlled Trial of a 42-Day Tapering Course of Dexamethasone to Reduce the Duration of Ventilator Dependency in Very Low Birth Weight Infants: Outcome of Study Participants at 1-Year Adjusted Age By pediatrics.aappublications.org Published On :: 1999-07-01 T. Michael O'SheaJul 1, 1999; 104:15-21ARTICLES Full Article
random Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), A Randomized, Controlled Trial. I: Primary Outcomes By pediatrics.aappublications.org Published On :: 2000-02-01 The STOP-ROP Multicenter Study GroupFeb 1, 2000; 105:295-310ARTICLES Full Article
random Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial By pediatrics.aappublications.org Published On :: 2020-05-08T00:05:23-07:00 This phase IIb randomized controlled trial demonstrates greater efficacy of phenobarbital than levetiracetam in the treatment of neonatal seizures; more adverse events occurred with phenobarbital. Full Article
random Coronavirus: No community spread signs, random sample tests in March negative, says ICMR By www.financialexpress.com Published On :: 2020-03-18T09:54:00+05:30 This community transmission test is running separately from the testing and tracking of symptomatic travellers as well as those who have come in contact with confirmed Covid-19 cases. Full Article Health Lifestyle
random Linux/x86 Random Bytes Encoder + XOR/SUB/NOT/ROR execve(/bin/sh) Shellcode By packetstormsecurity.com Published On :: Thu, 09 Jan 2020 14:59:44 GMT 114 bytes small Linux/x86 random bytes encoder and XOR/SUB/NOT/ROR execve(/bin/sh) shellcode. Full Article
random Random Number Bug Blights FreeBSD By packetstormsecurity.com Published On :: Fri, 30 Nov 2007 21:21:25 GMT Full Article bsd
random FreeBSD Abandoning Hardware Randomness By packetstormsecurity.com Published On :: Tue, 10 Dec 2013 05:20:06 GMT Full Article headline flaw bsd nsa cryptography