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Winter H.S.,MassGeneral Hospital for Children | Krzeski P.,Medpace | Heyman M.B.,University of California at San Francisco | Ibarguen-Secchia E.,Methodist Childrens Hospital | And 9 more authors.
Journal of Pediatric Gastroenterology and Nutrition | Year: 2014

Objective: The aim of the study was to assess the safety and efficacy of highand low-dose oral, delayed-release mesalamine in a randomized, doubleblind, active control study of children with mild-to-moderately active ulcerative colitis.Methods: Patients ages 5 to 17 years, with a Pediatric Ulcerative Colitis Activity Index (PUCAI) score of ≥10 to ≤55 and a truncated Mayo Score of ≥1 for both rectal bleeding and stool frequency, were enrolled. They received body weight-dependent doses of oral, delayed-release mesalamine for 6 weeks in a low- (27-71 mg · g-1 · day-1) or highdose group (53-118 mg · g-1 · day-1). The primary endpoint was treatment success, defined as the proportion of patients who achieved remission (PUCAI score <10) or partial response (PUCAI score ≥10 with a decrease from baseline by ≥20 points). Secondary endpoints included truncated Mayo Score and global assessment of change of disease activity.Results: The modified intent-to-treat population included 81 of 83 patients enrolled. Treatment success by PUCAI was achieved by 23 of 41 (56%) and 22 of 40 (55%) patients in the mesalamine low- and high-dose groups, respectively (P=0.924). Truncated Mayo Score (low-dose 30 [73%] and high-dose 28 [70%] patients) and other efficacy results did not differ between the groups. The type and severity of adverse events were consistent with those reported in previous studies of adults with ulcerative colitis and did not differ between groups.Conclusions: Both low- and high-dose oral, delayed-release mesalamine doses were equally effective as short-term treatment of mild-to-moderately active ulcerative colitis in children, without a specific benefit or risk to using either dose. Copyright © 2014 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.


Roy S.L.,Centers for Disease Control and Prevention | Atkins J.T.,Methodist Childrens Hospital | Gennuso R.,Methodist Childrens Hospital | Kofos D.,Methodist Childrens Hospital | And 8 more authors.
Parasitology Research | Year: 2015

Balamuthia mandrillaris, a free-living ameba, causes rare but frequently fatal granulomatous amebic encephalitis (GAE). Few patients have survived after receiving experimental drug combinations, with or without brain lesion excisions. Some GAE survivors have been treated with a multi-drug regimen including miltefosine, an investigational anti-leishmanial agent with in vitro amebacidal activity. Miltefosine dosing for GAE has been based on leishmaniasis dosing because no data exist in humans concerning its pharmacologic distribution in the central nervous system. We describe results of limited cerebrospinal fluid (CSF) and serum drug level testing performed during clinical management of a child with fatal GAE who was treated with a multiple drug regimen including miltefosine. Brain biopsy specimens, CSF, and sera were tested for B. mandrillaris using multiple techniques, including culture, real-time polymerase chain reaction, immunohistochemical techniques, and serology. CSF and serum miltefosine levels were determined using a liquid chromatography method coupled to tandem mass spectrometry. The CSF miltefosine concentration on hospital admission day 12 was 0.4 μg/mL. The serum miltefosine concentration on day 37, about 80 h post-miltefosine treatment, was 15.3 μg/mL. These are the first results confirming some blood–brain barrier penetration by miltefosine in a human, although with low-level CSF accumulation. Further evaluation of brain parenchyma penetration is required to determine optimal miltefosine dosing for Balamuthia GAE, balanced with the drug’s toxicity profile. Additionally, the Balamuthia isolate was evaluated by real-time polymerase chain reaction (PCR), demonstrating genetic variability in 18S ribosomal RNA (18S rRNA) sequences and possibly signaling the first identification of multiple Balamuthia strains with varying pathogenicities. © 2015, Springer-Verlag Berlin Heidelberg (outside the USA).


PubMed | Centers for Disease Control and Prevention, University of California at San Francisco, Methodist Hospital, Netherlands Cancer Institute and Methodist Childrens Hospital
Type: Case Reports | Journal: Parasitology research | Year: 2015

Balamuthia mandrillaris, a free-living ameba, causes rare but frequently fatal granulomatous amebic encephalitis (GAE). Few patients have survived after receiving experimental drug combinations, with or without brain lesion excisions. Some GAE survivors have been treated with a multi-drug regimen including miltefosine, an investigational anti-leishmanial agent with in vitro amebacidal activity. Miltefosine dosing for GAE has been based on leishmaniasis dosing because no data exist in humans concerning its pharmacologic distribution in the central nervous system. We describe results of limited cerebrospinal fluid (CSF) and serum drug level testing performed during clinical management of a child with fatal GAE who was treated with a multiple drug regimen including miltefosine. Brain biopsy specimens, CSF, and sera were tested for B. mandrillaris using multiple techniques, including culture, real-time polymerase chain reaction, immunohistochemical techniques, and serology. CSF and serum miltefosine levels were determined using a liquid chromatography method coupled to tandem mass spectrometry. The CSF miltefosine concentration on hospital admission day 12 was 0.4g/mL. The serum miltefosine concentration on day 37, about 80h post-miltefosine treatment, was 15.3g/mL. These are the first results confirming some blood-brain barrier penetration by miltefosine in a human, although with low-level CSF accumulation. Further evaluation of brain parenchyma penetration is required to determine optimal miltefosine dosing for Balamuthia GAE, balanced with the drugs toxicity profile. Additionally, the Balamuthia isolate was evaluated by real-time polymerase chain reaction (PCR), demonstrating genetic variability in 18S ribosomal RNA (18S rRNA) sequences and possibly signaling the first identification of multiple Balamuthia strains with varying pathogenicities.


White J.T.,University of Texas Health Science Center at San Antonio | Samples D.C.,University of Texas Health Science Center at San Antonio | Prieto J.C.,University of Texas Health Science Center at San Antonio | Prieto J.C.,Childrens Hospital Of San Antonio | And 2 more authors.
Current Urology Reports | Year: 2015

Tethered cord syndrome describes a condition of multisystem end organ dysfunction due to fixation of the spinal cord. This systematic review focuses on the closed skin variant of this condition, occult spinal dysraphism. The embryology, pathophysiology, presentation, and classification of occult spinal dysraphism are explained to develop a simple framework for discussions regarding this often confusing condition. Following Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines, we synthesized urologic outcome data after tethered cord release in children from 17 studies performed over the past 25 years. These results prompted several conclusions. First, the different subgroups and different nomenclature of tethered cord syndrome are often confused, making interpretation of results difficult. Second, untethering has a positive effect on urologic symptoms and urodynamics parameters. Third, timing of untethering is important: early intervention prevents significant long-term traction aiming to avoid irreversible neurologic damage. Fourth, pediatric urologists and neurosurgeons have an important role in diagnosing and treating this condition and should work closely as part of a multidisciplinary team. © 2015, Springer Science+Business Media New York.


Azakie A.,Methodist Childrens Hospital
Operative Techniques in Thoracic and Cardiovascular Surgery | Year: 2015

Anomalous origin of the left coronary artery from the pulmonary artery (ALCAPA), a rare congenital cardiac lesion, is an important cause of myocardial ischemia and infarction in children, and carries a high mortality in the first year of life. In the current era, repair of ALCAPA is most commonly performed by aortic implantation. Coronary elongation techniques are available for cases where the ectopic coronary artery originates at point in the pulmonary artery that is distant from the aortic root. In cases where clinically significant mitral regurgitation (MR) is present mitral valve repair is usually not performed. The early outcomes for aortic implantation of ALCAPA are excellent in the current era, with survival rates exceeding 90%. A small number of children, those who present with cardiogenic shock and very poor ventricular function, may require post-repair mechanical circulatory support using ECMO or LVAD and still have high survival rates and expect good long-term recovery. Following repair of ALCAPA by aortic implantation, ventricular functional parameters such as depressed ejection fraction, ventricular dilation and MR should recover within 8 months of repair. © 2015 Elsevier Inc.


PubMed | Methodist Childrens Hospital
Type: Journal Article | Journal: Journal of pediatric oncology nursing : official journal of the Association of Pediatric Oncology Nurses | Year: 2013

The number of pediatric bone marrow transplants is increasing for malignant and nonmalignant diseases. The number of survivors is also increasing, and their long-term health and protection from infection is increasingly important. To prevent infections, it is standard practice to re-immunize pediatric patients after bone marrow transplant (BMT) using the Centers for Disease Control and Prevention immunization guidelines; however, surveys in the United States and other parts of the world indicate that many BMT patients do not receive all the recommended immunizations. A literature review was conducted to identify research based on evidence for immunization following BMT and to recognize barriers to the process. Also, the immunization clinical guidelines from 2000 and 2011 for patients following BMT were compared and an updated clinical protocol and immunization schedule was developed to reflect the current evidence, encourage a change in practice, and discourage fragmented care.

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