Following the Framework: Intentional Genomic Alterations in Animals

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, there are products currently approved and on the market. These products are facing legal hurdles as well as consumer backlash. This paper will address what intentional genomic alterations in animals are, the framework that established the regulatory structure surrounding these products, the current relevant regulatory guidance, the IGA products currently on the market and the legal issues facing these products

Risk of Developmental Disorders in Children Born at 32 to 38 Weeks' Gestation : A Meta-Analysis

CONTEXT: Very preterm birth (<32 weeks) is associated with increased risk of developmental disorders. Emerging evidence suggests children born 32 to 38 weeks might also be at risk. OBJECTIVES: To determine the relative risk and prevalence of being diagnosed with, or screening positive for, developmental disorders in children born moderately preterm, late preterm, and early term compared with term (≥37 weeks) or full term (39-40/41 weeks). DATA SOURCES: Medline, Embase, Psychinfo, Cumulative Index of Nursing, and Allied Health Literature. STUDY SELECTION: Reported ≥1 developmental disorder, provided estimates for children born 32 to 38 weeks. DATA EXTRACTION: A single reviewer extracted data; a 20% sample was second checked. Data were pooled using random-effects meta-analyses. RESULTS: Seventy six studies were included. Compared with term born children, there was increased risk of most developmental disorders, particularly in the moderately preterm group, but also in late preterm and early term groups: the relative risk of cerebral palsy was, for 32 to 33 weeks: 14.1 (95% confidence intervals [CI]: 12.3-16.0), 34 to 36 weeks: 3.52 (95% CI: 3.16-3.92) and 37 to 38 weeks: 1.44 (95% CI: 1.32-1.58). LIMITATIONS: Studies assessed children at different ages using varied criteria. The majority were from economically developed countries. All were published in English. Data were variably sparse; subgroup comparisons were sometimes based on single studies. CONCLUSIONS: Children born moderately preterm are at increased risk of being diagnosed with or screening positive for developmental disorders compared with term born children. This association is also demonstrated in late preterm and early term groups but effect sizes are smaller

Whether weather matters: Evidence of association between in utero meteorological exposures and foetal growth among Indigenous and non-Indigenous mothers in rural Uganda

Pregnancy and birth outcomes have been found to be sensitive to meteorological variation, yet few studies explore this relationship in sub-Saharan Africa where infant mortality rates are the highest in the world. We address this research gap by examining the association between meteorological factors and birth weight in a rural population in southwestern Uganda. Our study included hospital birth records (n = 3197) from 2012 to 2015, for which we extracted meteorological exposure data for the three trimesters preceding each birth. We used linear regression, controlling for key covariates, to estimate the timing, strength, and direction of meteorological effects on birth weight. Our results indicated that precipitation during the third trimester had a positive association with birth weight, with more frequent days of precipitation associated with higher birth weight: we observed a 3.1g (95% CI: 1.0–5.3g) increase in birth weight per additional day of exposure to rainfall over 5mm. Increases in average daily temperature during the third trimester were also associated with birth weight, with an increase of 41.8g (95% CI: 0.6–82.9g) per additional degree Celsius. When the sample was stratified by season of birth, only infants born between June and November experienced a significant associated between meteorological exposures and birth weight. The association of meteorological variation with foetal growth seemed to differ by ethnicity; effect sizes of meteorological were greater among an Indigenous subset of the population, in particular for variation in temperature. Effects in all populations in this study are higher than estimates of the African continental average, highlighting the heterogeneity in the vulnerability of infant health to meteorological variation in different contexts. Our results indicate that while there is an association between meteorological variation and birth weight, the magnitude of these associations may vary across ethnic groups with differential socioeconomic resources, with implications for interventions to reduce these gradients and offset the health impacts predicted under climate change

Risk of Developmental Disorders in Children Born at 32 to 38 Weeks’ Gestation: A Meta-Analysis

CONTEXT Very preterm birth (<32 weeks) is associated with increased risk of developmental disorders. Emerging evidence suggests children born 32 to 38 weeks might also be at risk. OBJECTIVES To determine the relative risk and prevalence of being diagnosed with, or screening positive for, developmental disorders in children born moderately preterm, late preterm, and early term compared with term (≥37 weeks) or full term (39–40/41 weeks). DATA SOURCES Medline, Embase, Psychinfo, Cumulative Index of Nursing, and Allied Health Literature. STUDY SELECTION Reported ≥1 developmental disorder, provided estimates for children born 32 to 38 weeks. DATA EXTRACTION A single reviewer extracted data; a 20% sample was second checked. Data were pooled using random-effects meta-analyses. RESULTS Seventy six studies were included. Compared with term born children, there was increased risk of most developmental disorders, particularly in the moderately preterm group, but also in late preterm and early term groups: the relative risk of cerebral palsy was, for 32 to 33 weeks: 14.1 (95% confidence intervals [CI]: 12.3–16.0), 34 to 36 weeks: 3.52 (95% CI: 3.16–3.92) and 37 to 38 weeks: 1.44 (95% CI: 1.32–1.58). LIMITATIONS Studies assessed children at different ages using varied criteria. The majority were from economically developed countries. All were published in English. Data were variably sparse; subgroup comparisons were sometimes based on single studies. CONCLUSIONS Children born moderately preterm are at increased risk of being diagnosed with or screening positive for developmental disorders compared with term born children. This association is also demonstrated in late preterm and early term groups but effect sizes are smaller

Late Ordovician (Hirnantian) Diploporitan Fauna of Anticosti Island, Quebec, Canada: Implications for Evolutionary and Biogeographic Patterns

Hirnantian (latest Ordovician) localities containing echinoderm fossils are rare; the few that have been discovered primarily contain disarticulated crinoid ossicles. Therefore, relatively little is known about echinoderm evolutionary dynamics across the Late Ordovician – early Silurian boundary, especially noncrinoid echinoderms. New diploporitan echinoderms, Holocystites salmoensis and an unidentified holocystitid, from reefal facies of the Upper Ordovician Ellis Bay Formation of Anticosti Island provide a critical data point concerning diploporitan biogeography and evolutionary pathways undertaken during the Ordovician and Silurian. These fossils also provide a crucial link in understanding the ancestry of the Silurian Holocystites Fauna, an unusual diploporitan fauna from the middle Silurian of North America, whose origination dates back at least 15 million years earlier than previously thought with the discovery of taxa described here. New fossil data such as these stress the importance of uncovering new localities from underrepresented times and places in Earth’s history, so that these evolutionary transitions can be better understood

Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial)

INTRODUCTION: Based on epidemiological, immunological and pathology data, the idea that appendicitis is not necessarily a progressive disease is gaining ground. Two types are distinguished: simple and complicated appendicitis. Non-operative treatment (NOT) of children with simple appendicitis has been investigated in several small studies. So far, it is deemed safe. However, its effectiveness and effect on quality of life (QoL) have yet to be established in an adequately powered randomised trial. In this article, we provide the study protocol for the APAC (Antibiotics versus Primary Appendectomy in Children) trial. METHODS AND ANALYSIS: This multicentre, non-inferiority, randomised controlled trial randomises children aged 7-17 years with imaging-confirmed simple appendicitis between appendectomy and NOT. Patients are recruited in 15 hospitals. The intended sample size, based on the primary outcome, rate of complications and a non-inferiority margin of 5%, is 334 patients.NOT consists of intravenous antibiotics for 48-72 hours, daily blood tests and ultrasound follow-up. If the patient meets the predefined discharge criteria, antibiotic treatment is continued orally at home. Primary outcome is the rate of complications at 1-year follow-up. An independent adjudication committee will assess all complications and their relation to the allocated treatment. Secondary outcomes include, but are not limited to, delayed appendectomies, QoL, pain and (in)direct costs.The primary outcome will be analysed both according to the intention-to-treat principle and the per-protocol principle, and is presented with a one-sided 97.5% CI. We will use multiple logistic and linear regression for binary and continuous outcomes, respectively, to adjust for stratification factors. ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Ethics Review Committee of the Academic Medical Center, Amsterdam. Data monitoring is performed by an independent institute and a Data Safety Monitoring Board has been assigned. Results will be presented in peer-reviewed academic journals and at (international) conferences. TRIAL REGISTRATION NUMBER: NCT02848820; NTR5977; Pre-results