LATUDA Phase 3 Study Demonstrates Improvement in Pediatric and Adolescent Bipolar Depression

MedicalResearch.com Interview with:

Antony Loebel, M.D. Executive Vice President and Chief Medical Officer Sunovion, Head of Global Clinical Development Sumitomo Dainippon Pharma Group

Dr. Loebel

Antony Loebel, M.D.
Executive Vice President and Chief Medical Officer
Sunovion, Head of Global Clinical Development
Sumitomo Dainippon Pharma Group

MedicalResearch.com: What is the background for this study? What are the main findings?

In the six-week, randomized, double-blind, placebo-controlled study, 347 children and adolescents (10 to 17 years of age) with bipolar depression received once-daily LATUDA flexibly dosed (20-80 mg/day) or placebo.The Phase 3 clinical study met its primary endpoint, showing statistically significant and clinically meaningful improvement in symptoms compared to placebo. LATUDA was generally well tolerated, with minimal effects on weight and metabolic parameters.

The primary efficacy endpoint was change from baseline to week 6 on the Children Depression Rating Scale, Revised (CDRS-R) total score. LATUDA was associated with statistically significant and clinically meaningful improvement in bipolar depression symptoms compared to placebo, based on CDRS-R total score (-21.0 vs. -15.3; effect size = 0.45; p<0.0001) and CGI-BP-S score for depression (-1.49 vs. -1.05; effect size = 0.44; p<0.001).

LATUDA also demonstrated statistically significant improvement on secondary efficacy endpoints.

The most common treatment-emergent adverse events reported for LATUDA compared to placebo were nausea (16% vs. 5.8%), somnolence (9.1% vs. 4.7%), weight gain (6.9% vs. 1.7%), vomiting (6.3% vs. 3.5%), dizziness (5.7% vs. 4.7%) and insomnia (5.1% vs. 2.3%). LATUDA was associated with no increases in fasting glucose or lipids, and minimal increase in mean weight vs. placebo (+0.74 kg vs. +0.44 kg).

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Babies As Young as 3-5 Months Taught To Stand

MedicalResearch.com Interview with:
Professor Hermundur Sigmundsson

Department of Psychology
Norwegian University of Science and Technology

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There are around 23 baby-swimming instructors in Iceland who are offering baby swimming-courses. However, Snorris way to do this is unice after my knowledge.

He has been doing baby swimming from 1990 – and has had around 7.000.- babies

He heard about this from Norway and discovered that very young babies can stand in this way. He discovered this through practical experience.

It works like this:  When holding children in the water – He put his hand under the feet of the children – and lift little bit under i.e gives some pressure (tactile stimuli) the children are gradually able to stand in the feet – so stimuli and experience is important. When they are able to stand once they are able to stand again.

How long time it takes for each baby to be able to stand varies a lot – as in our study – the youngest was 3.6 months old. One of the participants was standing in 15 sec in the hands of Snorri in the first week of baby swimming course.

I did see babies stand first soon after Snorri started baby swimming instruction around 1990-1991.

I was very surprised – and was thinking how is it possible? This is not supported by the literature. My colleagues an I thought about this as a window to study development of balance and coordination in infants. The issue about reflexes versus voluntary movement through experience was central.

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Adolescents Admitted For Self Harm At Risk For Further Self Harming Behavior

MedicalResearch.com Interview with:

Dr Annie Herbert, PhD Department of Behavioural Science and Health, Institute of Epidemiology and Healthcare University College London London  UK

Dr. Herbert

Dr Annie Herbert, PhD
Department of Behavioural Science and Health, Institute of Epidemiology and Healthcare
University College London
London  UK 

MedicalResearch.com: What is the background for this study?

Response: 1 in 25 adolescents (i.e. one in every classroom) will be admitted to hospital as an emergency with injuries related self-harm, drug or alcohol misuse, or violence. Currently, the guidelines for how these adolescents are managed differ greatly depending on the type of injury they come in with (whether through self-harm, drug or alcohol misuse, or violence).

MedicalResearch.com: What are the main findings?

Response: In our study, we found that adolescents admitted with any of these injuries were at an increased risk of suicide and of drug or alcohol related death in the ten years after leaving hospital, compared to other admitted adolescents.While the overall risk is relatively low—for example, 2–3 girls out of 1000 and 7 boys out of 1000 who are admitted as an emergency to hospital with drug or alcohol related injuries die from suicide within 10 years—the rates are 5–6 times higher than among adolescents admitted to hospital following an accident.

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Finnish-Style Baby Box Reduced Parent-Baby Bed Sharing

MedicalResearch.com Interview with:

Megan Heere, MD Assistant Professor of Clinical Pediatrics Lewis Katz School of Medicine at Temple University Medical Director Temple University Hospital Well Baby Nursery Temple Pediatric Care Philadelphia, PA 19140

Dr. Heere

Megan Heere, MD
Assistant Professor of Clinical Pediatrics
Lewis Katz School of Medicine at Temple University
Medical Director
Temple University Hospital Well Baby Nursery
Temple Pediatric Care
Philadelphia, PA 19140

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Bed-sharing, the unsafe practice in which parents sleep in the same bed as their babies, is associated with sleep-related deaths in infants, including sudden infant death syndrome (SIDS) and accidental suffocation and strangulation in bed. No studies have examined the effect of a Finnish-style baby box on infant sleep environment. Face-to-face postpartum education about safe infant sleep, combined with the distribution of a baby box, which is a cardboard bassinet, reduced the rates of bed-sharing during babies’ first 8 days of life.

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Stop Using Cotton Tip Applicators in Kids’ Ears

MedicalResearch.com Interview with:

Kris Jatana, MD FAAP Pediatric Otolaryngologist Nationwide Children’s Hospital

Dr. Jatana

Kris Jatana, MD FAAP
Pediatric Otolaryngologist
Nationwide Children’s Hospital

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study looked at a 21-year period – 1990 through 2010 – and focused on children younger than 18 years of age treated in U.S. hospital emergency departments for cotton tip applicator-related ear injuries. About 263,000 children were injured during the study period, which comes out to approximately 1000 injuries seen in emergency departments every month or 34 per day.

The majority of injuries occurred when cotton tip applicators were used to clean a child’s ear canal (73%), and most of those injuries occurred when a child was using a cotton tip applicator on their own (77%), or their parent was using the device (16%) to clean the ear canal. About two out of every three patients were younger than 8 years of age, and patients aged 0-3 years accounted for 40% of all injuries.

Surprisingly, the highest rate of injury was in children 0-3 years old. The most common injuries were foreign body sensation (30%), perforated ear drum (25%) and soft tissue injury (23%).

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Regions With Strict Gun Control Laws Have Lower Rates of Pediatric Gun Injuries

MedicalResearch.com Interview with:

Monika Goyal, M.D., M.S.C.E. Assistant Professor of Pediatrics & Emergency Medicine Director of Research, Division of Emergency Medicine Attending Physician Children’s National Health System The George Washington University

Dr. Monika Goyal

Monika Goyal, M.D., M.S.C.E.
Assistant Professor of Pediatrics & Emergency Medicine
Director of Research, Division of Emergency Medicine and Attending Physician
Children’s National Health System
The George Washington University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: As pediatric emergency clinicians, unfortunately, many of us have cared for a number of children who have been victims of gun violence. We wanted to investigate whether gun laws may make a difference in the rates of firearm-related morbidity and mortality in children. We specifically were interested in emergency department visits because they relate directly to the care we provide to pediatric patients.

Our main findings from our five-year study were that children are affected by gun violence nationally and, specifically, we saw regional differences in emergency department visits made by children who were victims of firearm violence.

Overall, firearm-related visits by patients 21 and younger to emergency departments remained consistent over time at a rate of 65 per every 100,000 visits until 2013, when they decreased slightly to 51 per 100,000 visits.

We also found that regions with more strict gun laws had lower rates of emergency department visits by children for gun violence compared with those regions with less stringent laws. We used the Brady Score, which looks at various state gun laws and assigns a score, to measure strictness. Then, based on state-level scores, we created regional composite scores.

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Saliva Test Can Predict Concussion Duration in Children

MedicalResearch.com Interview with:

Steven Daniel Hicks, MD, PhD Assistant Professor, Division of Academic General Pediatrics College of Medicine Penn State Health

Dr. Hicks

Steven Daniel Hicks, MD, PhD
Assistant Professor, Division of Academic General Pediatrics
College of Medicine
Penn State Health

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There are about 3 million concussions in the US each year and the majority occur in children. Parents of children with concussions commonly cite length of recovery as a major concern, but pediatricians have no objective or accurate tests for addressing this concern.

Our research group previously identified small regulatory molecules called microRNAs that were altered in both the spinal fluid and saliva in children with traumatic brain injuries. In this study we investigated whether those microRNAs could predict duration of concussion symptoms. In 52 children with concussion we found a set of microRNAs that predict whether concussion symptoms would last beyond one month with over 80% accuracy. This was significantly more accurate than survey based tools such as the sports concussion assessment tool or a modified concussion clinical risk score. Interestingly, the microRNAs with predictive accuracy targeted pathways involved in brain repair and showed correlations with specific concussion symptoms.

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Fatty Acids From Fish During Infancy May Lower Risk of Type 1 Diabetes

MedicalResearch.com Interview with:

Sari Niinistö, PhD Senior Researcher, Public Health Solutions, Nutrition Unit National Institute for Health and Welfare Helsinki, Finland

Dr. Niinistö

Sari Niinistö, PhD
Senior Researcher,
Public Health Solutions, Nutrition Unit
National Institute for Health and Welfare
Helsinki, Finland

MedicalResearch.com: What is the background for this study?

Response: Previous prospective studies have observed protective association between fish-derived fat and type 1 diabetes related autoimmunity in older children. Also some other fatty acids have been associated with the risk for type 1 diabetes associated autoimmunity. We wanted to study very young children, because type 1 diabetes associated autoimmunity often begins early, already in infancy. Therefore, we investigated whether serum fatty acid levels during infancy or the main dietary sources of fatty acids (breast milk and infant formula) were related to the development of autoimmunity responses among children at increased genetic risk of developing type 1 diabetes.

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Arsenic Still Found In Infant Rice Products

MedicalResearch.com Interview with:

Dr. Antonio J. Signes-Pastor, PhD Institute for Global Food Security Queen’s University Belfast Belfast, Northern Ireland, United Kingdom, Department of Epidemiology, Geisel School of Medicine Dartmouth College Lebanon, NH

Dr. Signes-Pastor

Dr. Antonio J. Signes-Pastor, PhD
Institute for Global Food Security
Queen’s University Belfast
Belfast, Northern Ireland, United Kingdom,
Department of Epidemiology, Geisel School of Medicine
Dartmouth College Lebanon, NH

MedicalResearch.com: What is the background for this study?

Response: Inorganic arsenic is a human carcinogen, which has also been associated with several adverse health effects including neurological, cardiovascular, respiratory, and metabolic outcomes. Early life exposure is of particular concern since it may adversely impact on lifetime health outcomes. If low inorganic arsenic drinking water is available the main source of exposure is the diet, especially rice and rice-based products, which are widely used during weaning and to feed infants and young children. In order to reduce exposure, the EU has recently regulated (1st January 2016) the inorganic arsenic maximum level of 0.1 mg/kg for rice products addressed to infants and young children. This level is also under consideration by the US FDA.

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Number of Preschool Children With Visual Impairment Projected To Rise

MedicalResearch.com Interview with:

Rohit Varma, MD, MPH</strong> Executive Director - USC Roski Eye Institute and Dean of the Keck School of Medicine of USC

Dr. Varma

Rohit Varma, MD, MPH
Executive Director – USC Roski Eye Institute and
Dean of the Keck School of Medicine of USC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Visual impairment in early childhood has profound impact on a child’s development. It can significantly impair development of visual, motor, and cognitive function1-3 and lead to adverse psychosocial consequences. There has been a lack of accurate data characterizing the current and expected numbers of visual impairment cases among preschool children in the United States from 2015 to 2060.

The number of preschool children with visual impairment is projected to increase by 26% in 2060. And 69% of these visual impairment will result from simple uncorrected refractive error such hyperopia and myopia, which can be prevented or treated by low-cost refractive correction.

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Having A Dog Doesn’t Protect Kids From Type 1 Diabetes

MedicalResearch.com Interview with:

Tove Fall, PhD Department of Medical Sciences Molecular Epidemiology and Science for Life Laboratory, Uppsala University Uppsala, Sweden

Dr. Tove Fall

Tove Fall, PhD
Department of Medical Sciences
Molecular Epidemiology and Science for Life Laboratory, Uppsala University
Uppsala, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Type 1 diabetes is a severe chronic disease in children. There are few established risk factors, but it has been hypothesized that factors related to reduction of microbial exposure in childhood may increase the risk. We have previously shown that children in dog-owning families are at lower risk for asthma, and we now wanted to investigate the relationship of dog ownership and diabetes. We did this by studying the whole Swedish child population with record linkage across registers of health and dog ownership. We could not find evidence for an association of dog ownership and type 1 diabetes in the general population.

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Does Cell Phone Use During Pregnancy Increase Childhood Behavioral Problems?

MedicalResearch.com Interview with:
Laura Birks, MPH, Predoctoral Fellow
ISGlobal
Instituto de Salud Global de Barcelona – Campus MAR
Barcelona Biomedical Research Park (PRBB) (office 183.01B)
Barcelona, Spain

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Previous studies in Denmark and the Netherlands have reported associations between prenatal cell phone use and child behavioral problems, but findings have been inconsistent and based on retrospective assessment of cell phone use. This study aimed to assess this association in a multi-national analysis, using data from three cohorts with prospective data on prenatal cell phone use, together with previously published data from two cohorts with retrospectively collected cell phone use data.

We found that cell phone use during pregnancy was associated with increased risk for behavioral problems in offspring, specifically hyperactivity/inattention problems. This association was fairly consistent across cohorts and between cohorts with retrospectively and prospectively collected cell phone use data. While our models were adjusted for many confounders, it is possible that other factors could explain this association, such as hyperactivity in the mother or parenting styles (variables that were not collected in these cohorts). Furthermore, to date there is no known biological mechanism that could explain the association.

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