DNAtrix (United States)

Probiotic supplementation is associated with health benefits in preterm infants. The 2021 American Academy of Pediatrics (AAP) statement on probiotic use advised caution, citing heterogeneity and absence of federal regulation. We assessed the impact of the AAP statement and current institution-wide patterns of probiotic use across neonatal intensive care units (NICU) across the United States. A cross-sectional web-based institutional survey using REDCap was emailed to 430 Children's Hospital Neonatal Consortium (CHNC) and Pediatrix Medical Group institutions. The survey captured data on probiotic formulations, supplementation, initiation and cessation criteria, reasons for discontinuation, interest in initiating, and AAP statement's impact. Ninety-five (22.1%) hospitals, including 42/46 (91%) CHNC and 53/384 (14%) Pediatrix institutions, completed the survey. Thirty-seven (39%) currently use probiotics. Fourteen different probiotic formulations were reported. The common criteria for initiation were birth weight <1,500 g and gestational age <32 weeks. Parental consent or assent was obtained at only 30% of institutions. Five hospitals (11%) with prior probiotic use discontinued solely due to the AAP statement. Overall, 23 (24%) of hospitals indicated that the AAP statement significantly influenced their decision regarding probiotic use. Nineteen of 51 nonusers (37%) are considering initiation. Probiotic use in preterm infants is likely increasing in NICUs across the United States, but significant variability exists. The 2021 AAP statement had variable impact on NICUs' decision regarding probiotic use. The growing interest in adopting probiotics and the significant interhospital variability highlight the need for better regulation and consensus guidelines to ensure standardized use. · Probiotic use in preterm infants is likely increasing in U.S. NICUs, but clinical variability exists.. · The AAP statement on probiotic use in preterm infants had a modest impact on current practices.. · There's a need for better product regulation and consensus guidelines to ensure standardized use..

BackgroundNoise exposure in the neonatal intensive care unit (NICU) is consistently higher than current recommendations. This may adversely affect neonatal sleep, weight gain, and overall health. We sought to evaluate the effect of a novel active noise control (ANC) system.MethodsAn ANC device’s noise reduction performance was compared to that of adhesively affixed foam ear covers in response to alarm and voice sounds in a simulated NICU environment. The zone of noise reduction of the ANC device was quantified with the same set of alarm and voice sounds.ResultsThe ANC device provided greater noise reduction than the ear covers in seven of the eight sound sequences tested in which a noise reduction greater than the just noticeable difference was achieved. For noise in the 500 Hz octave band, the ANC device exhibited consistent noise reduction throughout expected patient positions. It provided better performance for noise below 1000 Hz than above 1000 Hz.ConclusionsThe ANC device provided generally superior noise reduction to the ear covers and provided a zone of noise reduction throughout the range where an infant would be placed within an incubator. Implications for patient sleep and weight gain are discussed.ImpactActive noise control device can effectively reduce noise inside an infant incubator due to bedside device alarms.This is the first analysis of an incubator-based active noise control device and comparison to adhesively affixed silicone ear covers.A non-contact noise reduction device may be an appropriate means of reducing noise exposure of the hospitalized preterm infant.

Bronchopulmonary dysplasia (BPD) is the most common complication of extreme prematurity. Its etiology is multifactorial and is attributed to genetic susceptibility to prenatal and postnatal factors. As advancements in neonatology have led to the increased survival of premature infants, a parallel increase in the incidence of BPD has occurred. Over time, the definition and diagnostic criteria for BPD have evolved, as have management strategies. However, challenges continue to exist in the management of these infants, which is not surprising given the complexity of the disease. We summarize the key diagnostic criteria and provide insight into the challenges related to various aspects of BPD definitions, data comparisons, and clinical care implementation.

The aim of this study was to determine the relationship between iron exposure and the development of bronchopulmonary dysplasia (BPD). A secondary analysis of the PENUT Trial dataset was conducted. The primary outcome was BPD at 36 weeks gestational age and primary exposures of interest were cumulative iron exposures in the first 28 days and through 36 weeks' gestation. Descriptive statistics were calculated for study cohort characteristics with analysis adjusted for the factors used to stratify randomization. Of the 941 patients, 821 (87.2%) survived to BPD evaluation at 36 weeks, with 332 (40.4%) diagnosed with BPD. The median cohort gestational age was 26 weeks and birth weight 810 g. In the first 28 days, 76% of infants received enteral iron and 55% parenteral iron. The median supplemental cumulative enteral and parenteral iron intakes at 28 days were 58.5 and 3.1 mg/kg, respectively, and through 36 weeks' 235.8 and 3.56 mg/kg, respectively. We found lower volume of red blood cell transfusions in the first 28 days after birth and higher enteral iron exposure in the first 28 days after birth to be associated with lower rates of BPD. We find no support for an increased risk of BPD with iron supplementation. NCT01378273. https://clinicaltrials.gov/ct2/show/NCT01378273 IMPACT: Prior studies and biologic plausibility raise the possibility that iron administration could contribute to the pathophysiology of oxidant-induced lung injury and thus bronchopulmonary dysplasia in preterm infants. For 24-27-week premature infants, this study finds no association between total cumulative enteral iron supplementation at either 28-day or 36-week postmenstrual age and the risk for developing bronchopulmonary dysplasia.

Since 2010, the American College of Obstetrics and Gynecology have released three committee opinions to recommend and reaffirm the utility of magnesium sulfate for neuroprotection and later for tocolysis to achieve antenatal steroid course completion in preterm labor. We sought to determine changes in antenatal magnesium sulfate exposure and other tocolytic agents for pregnancies resulting in neonatal intensive care unit (NICU)-admitted preterm infants. Using the Pediatrix Clinical Data Warehouse, we evaluated all inborn infants delivered between 22 and 33 weeks' gestation and admitted to the intensive care units from 2009 to 2018. We classified patients based on antenatal exposure to tocolytic medications: calcium channel blockers (nifedipine and amlodipine), betamimetics (terbutaline, theophylline, and ritodrine), prostaglandin inhibitors (indomethacin), and magnesium sulfate. A total of 229,781 patients met inclusion criteria. During the study period, magnesium sulfate exposure increased from 27.6 to 57.7% of births while betamimetic exposure decreased from 10.2 to 5.2%. Increasing magnesium sulfate exposure over time was seen at all gestational ages examined and magnesium exposure was most common between 23 and 31 weeks' gestation. By 2017 to 2018, 70.5% of 24 to 29 weeks' gestation NICU infants received exposure to at least one tocolytic agent while this remained at 53.7% of 32 to 33 weeks' NICU admitted infants. Antenatal steroid exposure increased from 74.8 to 87.4% during the study period. For NICU-admitted preterm infants, prenatal exposure patterns to tocolytic agents has shifted since 2009 with prenatal magnesium sulfate exposure increasing significantly. Antenatal steroid exposure has risen concurrently. Exposure to tocolytic agents is the highest among preterm infants born between 24 and 29 weeks' gestation. · Exposure to magnesium sulfate significantly increased from 2009 to 2018 for NICU admitted infants.. · Concurrently, the use of other tocolytics decreased significantly.. · The use of antenatal steroids has been rising over time..

BACKGROUND DNX-2401 (tasadenoturev) is a replication-competent, tumor-selective, oncolytic adenovirus. A dose-escalating, Phase II study of a single intratumoral injection of DNX-2401 with pembrolizumab to determine optimal dose, safety and efficacy is ongoing and enrolling up to 48 patients with recurrent glioblastoma. Key inclusion criteria include patients with a single lesion at first or second recurrence for which resection is not possible or planned.

Diffuse intrinsic pontine gliomas (DIPGs) are aggressive glial brain tumors that primarily affect children, for which there is no curative treatment. Median overall survival is only one year. Currently, the scientific focus is on expanding the knowledge base of the molecular biology of DIPG, and identifying effective therapies. Oncolytic adenovirus DNX-2401 is a replication-competent, genetically modified virus capable of infecting and killing glioma cells, and stimulating an anti-tumor immune response. Clinical trials evaluating intratumoral DNX-2401 in adults with recurrent glioblastoma have demonstrated that the virus has a favorable safety profile and can prolong survival. Subsequently, these results have encouraged the transition of this biologically active therapy from adults into the pediatric population. To this aim, we have designed a clinical Phase I trial for newly diagnosed pediatric DIPG to investigate the feasibility, safety, and preliminary efficacy of delivering DNX-2401 into tumors within the pons following biopsy. This case report presents a pediatric patient enrolled in this ongoing Phase I trial for children and adolescents with newly diagnosed DIPG. The case involves an 8-year-old female patient with radiologically diagnosed DIPG who underwent stereotactic tumor biopsy immediately followed by intratumoral DNX-2401 in the same biopsy track. Because there were no safety concerns or new neurological deficits, the patient was discharged 3 days after the procedures. To our knowledge, this is the first report of intratumoral DNX-2401 for a patient with DIPG in a clinical trial. We plan to demonstrate that intratumoral delivery of an oncolytic virus following tumor biopsy for pediatric patients with DIPG is a novel and feasible approach and that DNX-2401 represents an innovative treatment for the disease.

DNX-2401 is an oncolytic adenovirus that has been tested in clinical studies for treating recurrent glioblastoma. It has also been shown in animal models of cancer that DNX-2401 exhibits synergy when combined with a variety of agents, including temozolomide. A clinical study of DNX-2401 followed by temozolomide was conducted to investigate this further. To investigate safety, OR, and OS following treatment with DNX-2401 and temozolomide. Patients at first recurrence after prior surgery, radiotherapy, and temozolomide were treated (n=31). A tumor resection or biopsy was performed to confirm recurrent disease. All patients received a single intraparenchymal injection of 3e10 vp DNX-2401 followed by 4 cycles of 150 mg/m2temozolomide (7 days on/7 days off) 2–4 weeks later. Ninety-four percent (94%) of patients completed all 4 planned cycles. Grade 3–4 adverse events were consistent with toxicities associated with temozolomide (lymphopenia) or the underlying disease (headache, mental impairment). Several objective responses were observed. One patient with unmethylated MGMT is alive 30 months after study treatment in the absence of progression or need for further treatment. Two additional patients are alive after 23 months. The study is ongoing and results will be updated. The study results demonstrate that DNX-2401 with temozolomide can be safely administered. Indications of clinical activity after recurrence supports additional investigation in this setting and evaluation in front-line glioblastoma.

We studied the diet of a population of Senegal running frogs Kassina senegalensis, a ground dwelling hyperoliid. Prey inventories were collected in May by stomach flushing 27 male and 28 female frogs from one population from Bénoué National Park, Cameroon. Sexes did not differ in body size, or size or number of prey items. The most frequently taken prey item was Orthoptera (36%) and Hymenoptera (24%) and Aranae (10%) followed it. The proportion of the 1087 prey samples in the litter did not differ significantly from 625 samples from the frog stomach, indicating a low degree of prey electivity. The data suggest Senegal running frog to be a wide foraging generalist.