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1.  Bringing your tools to CyVerse Discovery Environment using Docker 
F1000Research  2016;5:1442.
Docker has become a very popular container-based virtualization platform for software distribution that has revolutionized the way in which scientific software and software dependencies (software stacks) can be packaged, distributed, and deployed. Docker makes the complex and time-consuming installation procedures needed for scientific software a one-time process. Because it enables platform-independent installation, versioning of software environments, and easy redeployment and reproducibility, Docker is an ideal candidate for the deployment of identical software stacks on different compute environments such as XSEDE and Amazon AWS. CyVerse’s Discovery Environment also uses Docker for integrating its powerful, community-recommended software tools into CyVerse’s production environment for public use. This paper will help users bring their tools into CyVerse Discovery Environment (DE) which will not only allows users to integrate their tools with relative ease compared to the earlier method of tool deployment in DE but will also help users to share their apps with collaborators and release them for public use.
PMCID: PMC5070597  PMID: 27803802
CyVerse; virtualization platform; Discovery Environment
2.  Perceptions of Obesity Treatment Options Among Healthcare Providers and Low-Income Primary Care Patients 
The Ochsner Journal  2016;16(2):158-165.
Primary care is a key component of medical care delivery and has a role to play in reducing obesity in the United States. The purpose of this study was to explore attitudes and perceptions about obesity in low-income primary care patients and to identify preferences for weight management interventions from the patient and healthcare provider perspectives.
A convenience sample of 28 patients and 6 healthcare providers from across the state of Louisiana participated in 1 of 5 structured focus groups. Demographic information was collected from both the patients and healthcare providers using survey instruments.
Patients and healthcare providers were more similar than dissimilar in their perceptions of obesity in that both groups selected referral to a nutritionist, use of medication, and prescribed exercise as the top 3 strategies that would have the greatest impact on losing weight. Referral to a nutritionist was selected as the easiest strategy to implement.
Receiving feedback from both patients and healthcare providers gives researchers the opportunity to acquire useful knowledge that may be beneficial in designing and conducting interventions suitable for patients desiring to lose weight, especially those in primary care settings.
PMCID: PMC4896661  PMID: 27303227
Obesity; primary health care; weight loss; weight reduction programs
3.  Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993–2012 
JAMA  2015;314(10):1039-1051.
Extremely preterm infants contribute disproportionately to neonatal morbidity and mortality.
To review 20-year trends in maternal/neonatal care, complications, and mortality among extremely preterm infants born at Neonatal Research Network centers.
Design, Setting, Participants
Prospective registry of 34,636 infants 22–28 weeks’ gestational age (GA) and 401–1500 gram birthweight born at 26 Network centers, 1993–2012.
Extremely preterm birth.
Main Outcomes
Maternal/neonatal care, morbidities, and survival. Major morbidities, reported for infants who survived more than 12 hours, were: severe necrotizing enterocolitis, infection, bronchopulmonary dysplasia, severe intracranial hemorrhage, cystic periventricular leukomalacia, and/or severe retinopathy of prematurity. Regression models assessed yearly changes, adjusting for study center, race/ethnicity, GA, birthweight for GA, and sex.
Use of antenatal corticosteroids increased from 1993 to 2012 (348/1431 [24%] to 1674/1919 [87%], p<0.001), as did cesarean delivery (625/1431 [44%] to 1227/1921 [64%], p<0.001). Delivery room intubation decreased from 1144/1433 (80%) in 1993 to 1253/1922 (65%) in 2012 (p<0.001). After increasing in the 1990s, postnatal steroid use declined to 141/1757 (8%) in 2004 (p<0.001), with no significant change thereafter. Although most infants were ventilated, continuous positive airway pressure without ventilation increased from 120/1666 (7%) in 2002 to 190/1756 (11%) in 2012 (p<0.001). Despite no improvement from 1993 to 2004, rates of late-onset sepsis declined between 2005 and 2012 for infants of each GA (median GA 26 weeks, 109/296 [37%] to 85/320 [27%], adjusted relative risk [aRR]: 0.93 [95% CI, 0.92–0.94]). Rates of other morbidities declined, but bronchopulmonary dysplasia increased between 2009 and 2012 for infants 26–27 weeks (26 weeks, 130/258 [50%] to 164/297 [55%], p<0.001). Survival increased between 2009 and 2012 for infants 23 weeks (41/152 [27%] to 50/150 [33%], aRR: 1.09 [95% CI, 1.05–1.14]) and 24 weeks (156/248 [63%] to 174/269 [65%], aRR: 1.05 [95% CI, 1.03–1.07]), with smaller relative increases for infants 25 and 27 weeks and no change for infants 22, 26 and 28 weeks. Survival without major morbidity increased approximately 2% per year for infants 25–28 weeks with no change for infants 22–24 weeks.
Conclusions and Relevance
Among extremely preterm infants born at US academic centers over the last 20 years, changes in maternal and infant care practices and modest reductions in several morbidities were observed, although bronchopulmonary dysplasia increased. Survival increased most markedly for infants born at 23 and 24 weeks and survival without major morbidity increased for infants 25–28 weeks. These findings may be valuable in counselling families and developing novel interventions.
PMCID: PMC4787615  PMID: 26348753
4.  PaCO2 in Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) 
To determine the association of PaCO2 with severe intraventricular hemorrhage (sIVH), bronchopulmonary dysplasia (BPD), and neurodevelopmental impairment (NDI) at 18–22 months in premature infants.
Secondary exploratory data analysis of SUPPORT.
Multiple referral NICUs.
1316 infants 24 0/7 to 27 6/7 weeks gestation randomized to different oxygenation (SpO2 target 85–89% vs 91–95%) and ventilation strategies.
Main Outcome Measures
Blood gases from postnatal days 0–14 were analyzed. Five PaCO2 variables were defined: minimum [Min], maximum [Max], standard deviation, average (time-weighted), and a 4 level categorical variable (hypercapnic [highest quartile of Max PaCO2], hypocapnic [lowest quartile of Min PaCO2], fluctuators [both hypercapnia and hypocapnia], and normocapnic [middle two quartiles of Max and Min PaCO2]). PaCO2 variables were compared for infants with and without sIVH, BPD, and NDI (+/− death). Multivariable logistic regression models were developed for adjusted results.
sIVH, BPD, and NDI (+/− death) were associated with hypercapnic infants and fluctuators. Association of Max PaCO2 and outcomes persisted after adjustment (Per 10 mmHg increase: sIVH/death: OR 1.27 [1.13–1.41]; BPD/death: OR 1.27 [1.12–1.44]; NDI/death: OR 1.23 [1.10–1.38], Death: OR 1.27 [1.12–1.44], all p <0.001). No interaction was found between PaCO2 category and SpO2 treatment group for sIVH/death, NDI/death, or death. Max PaCO2 was positively correlated with maximum FiO2 (rs0.55, p<0.0001) & ventilator days (rs0.61, p<0.0001).
Higher PaCO2 was an independent predictor of sIVH/death, BPD/death, and NDI/death. Further trials are needed to evaluate optimal PaCO2 targets for high risk infants.
PMCID: PMC4336211  PMID: 25425651
Infant; premature; Infant mortality; Infant; Premature; Diseases/epidemiology; Predictive value of tests; Prognosis; Intracranial hemorrhage; Blood Gas Analysis
5.  Definitions of cardiovascular insufficiency and relation to outcomes in critically ill newborn infants 
American journal of perinatology  2015;32(11):1024-1030.
We previously reported on the overall incidence, management and outcomes in infants with cardiovascular insufficiency (CVI). However, there are limited data on the relationship of the specific different definitions of CVI to short term outcomes in term and late preterm newborn infants.
To evaluate how 4 definitions of CVI relate to short term outcomes and death.
Study Design
The previously reported study was a multicenter, prospective cohort study of 647 infants ≥ 34 weeks gestation admitted to a Neonatal Research Network (NRN) newborn intensive care unit (NICU) and mechanically ventilated (MV) during their first 72 hours. The relationship of five short term outcomes at discharge and 4 different definitions of CVI were further analyzed.
All 4 definitions were associated with greater number of days on MV & days on O2. The definition using a threshold blood pressure (BP) measurement alone was not associated with days to full feeding, days in the NICU or death. The definition based on treatment of CVI was associated with all outcomes including death.
The definition using a threshold BP alone was not consistently associated with adverse short term outcomes. Using only a threshold BP to determine therapy may not improve outcomes.
PMCID: PMC4689139  PMID: 25825962
blood pressure; cardiovascular insufficiency; outcomes; newborn; infant
6.  Serial aEEG recordings in a cohort of extremely preterm infants: feasibility and safety 
Amplitude-integrated EEG (aEEG) monitoring is increasing in the neonatal population, but the safety and feasibility of performing aEEG in extremely preterm infants have not been systematically evaluated.
Inborn infants 230/7 – 286/7 weeks gestation or birth weight 401–1000 grams were eligible. Serial, six-hour aEEG recordings were obtained from first week of life until 36 weeks postmenstrual age. Adverse events were documented, and surveys evaluated the impact of the aEEGs on routine care. Success of performing aEEGs according to protocol and aEEG quality were assessed.
102 infants were enrolled, with 755 recordings performed. 83% of recordings were performed according to schedule, and 96% were without adverse event. Bedside nurses reported no interference with routine care for 89% of recordings. 92% of recordings had acceptable signal quality.
Serial aEEG monitoring is safe in preterm infants, with few adverse events and general acceptance by nursing staff.
PMCID: PMC4414657  PMID: 25474559
7.  Neurodevelopmental Outcomes of Extremely Preterm Infants Randomized to Stress Dose Hydrocortisone 
PLoS ONE  2015;10(9):e0137051.
To compare the effects of stress dose hydrocortisone therapy with placebo on survival without neurodevelopmental impairments in high-risk preterm infants.
Study Design
We recruited 64 extremely low birth weight (birth weight ≤1000g) infants between the ages of 10 and 21 postnatal days who were ventilator-dependent and at high-risk for bronchopulmonary dysplasia. Infants were randomized to a tapering 7-day course of stress dose hydrocortisone or saline placebo. The primary outcome at follow-up was a composite of death, cognitive or language delay, cerebral palsy, severe hearing loss, or bilateral blindness at a corrected age of 18–22 months. Secondary outcomes included continued use of respiratory therapies and somatic growth.
Fifty-seven infants had adequate data for the primary outcome. Of the 28 infants randomized to hydrocortisone, 19 (68%) died or survived with impairment compared with 22 of the 29 infants (76%) assigned to placebo (relative risk: 0.83; 95% CI, 0.61 to 1.14). The rates of death for those in the hydrocortisone and placebo groups were 31% and 41%, respectively (P = 0.42). Randomization to hydrocortisone also did not significantly affect the frequency of supplemental oxygen use, positive airway pressure support, or need for respiratory medications.
In high-risk extremely low birth weight infants, stress dose hydrocortisone therapy after 10 days of age had no statistically significant effect on the incidence of death or neurodevelopmental impairment at 18–22 months. These results may inform the design and conduct of future clinical trials.
Trial Registration NCT00167544
PMCID: PMC4573756  PMID: 26376074
8.  Executive Summary of the Workshop “Nutritional Challenges in the High Risk Infant” 
The Journal of pediatrics  2012;160(3):511-516.
In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invited an expert panel to a workshop to address the current knowledge gaps and lack of evidence-based guidelines that preclude optimal nutritional care for infants in neonatal intensive care units. Since much research needs to be done in this complex area of science, the group was requested to propose new research to rectify current deficiencies in this field. This paper provides a summary of the workshop presentations and discussions.
PMCID: PMC4530452  PMID: 22240111
prematurity; preterm infants; intensive care; infant; nutrition
10.  Serum Tocopherol Levels in Very Preterm Infants After a Single Dose of Vitamin E at Birth 
Pediatrics  2013;132(6):e1626-e1633.
Our aim was to examine the impact of a single enteral dose of vitamin E on serum tocopherol levels. The study was undertaken to see whether a single dose of vitamin E soon after birth can rapidly increase the low α-tocopherol levels seen in very preterm infants. If so, this intervention could be tested as a means of reducing the risk of intracranial hemorrhage.
Ninety-three infants <27 weeks’ gestation and <1000 g were randomly assigned to receive a single dose of vitamin E or placebo by gastric tube within 4 hours of birth. The vitamin E group received 50 IU/kg of vitamin E as dl-α-tocopheryl acetate (Aquasol E). The placebo group received sterile water. Blood samples were taken for measurement of serum tocopherol levels by high-performance liquid chromatography before dosing and 24 hours and 7 days after dosing.
Eighty-eight infants received the study drug and were included in the analyses. The α-tocopherol levels were similar between the groups at baseline but higher in the vitamin E group at 24 hours (median 0.63 mg/dL vs 0.42 mg/dL, P = .003) and 7 days (2.21 mg/dL vs 1.86 mg/dL, P = .04). There were no differences between groups in γ-tocopherol levels. At 24 hours, 30% of vitamin E infants and 62% of placebo infants had α-tocopherol levels <0.5 mg/dL.
A 50-IU/kg dose of vitamin E raised serum α-tocopherol levels, but to consistently achieve α-tocopherol levels >0.5 mg/dL, a higher dose or several doses of vitamin E may be needed.
PMCID: PMC3838534  PMID: 24218460
vitamin E; preterm infants
11.  Multiscale Representation of Genomic Signals 
Nature methods  2014;11(6):689-694.
Genomic information is encoded on a wide range of distance scales, ranging from tens of base pairs to megabases. We developed a multiscale framework to analyze and visualize the information content of genomic signals. Different types of signals, such as GC content or DNA methylation, are characterized by distinct patterns of signal enrichment or depletion across scales spanning several orders of magnitude. These patterns are associated with a variety of genomic annotations, including genes, nuclear lamina associated domains, and repeat elements. By integrating the information across all scales, as compared to using any single scale, we demonstrate improved prediction of gene expression from Polymerase II chromatin immunoprecipitation sequencing (ChIP-seq) measurements and we observed that gene expression differences in colorectal cancer are not most strongly related to gene body methylation, but rather to methylation patterns that extend beyond the single-gene scale.
PMCID: PMC4040162  PMID: 24727652
12.  Incidence, management and outcomes of cardiovascular insufficiency in critically ill term and late preterm newborn infants 
American journal of perinatology  2014;31(11):947-956.
To characterize the incidence, management and short term outcomes of cardiovascular insufficiency (CVI) in mechanically ventilated newborns, evaluating 4 separate pre-specified definitions.
Study Design
Multicenter, prospective cohort study of infants ≥34 weeks gestational age (GA) and on mechanical ventilation during the first 72 hours. CVI was prospectively defined as either (1) mean arterial pressure (MAP)
Of 647 who met inclusion criteria, 419 (65%) met ≥1 definition of CVI. Of these, 98% received fluid boluses, 36% inotropes and 17% corticosteroids. Of treated infants, 46% did not have CVI as defined by a MAP < GA ± signs of inadequate perfusion. Inotrope therapy was associated with increased mortality (11.1% vs. 1.3%; P < 0.05).
More than half of the infants met at least one definition of CVI. However, almost half of the treated infants met none of the definitions. Inotropic therapy was associated with increased mortality. These findings can help guide the design of future studies of CVI in newborns.
PMCID: PMC4127379  PMID: 24515617
blood pressure; cardiovascular insufficiency; mechanical ventilation; inotrope; fluid bolus; glucocorticoid; outcomes; newborn
To determine if current retinopathy of prematurity screening guidelines1 adequately identify treatable ROP in a contemporary cohort of extremely low gestation infants.
Study Design
Data from the Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial were used. Inborn infants 24 0/7 to 27 6/7 weeks gestational age with consent prior to delivery were enrolled in 2005-2009. Severe retinopathy of prematurity (Type 1 retinopathy of prematurity or treatment with laser, cryotherapy, or bevacizumab) or death was the primary outcome for the randomized trial. Examinations followed then current American Academy of Pediatrics (AAP) screening recommendations, beginning by 31-33 weeks postmenstrual age.2,3
1316 infants were enrolled in the trial. 997 of the 1121 who survived to first eye exam had final retinopathy of prematurity outcome determined. 137 (14% of 997) met criteria for severe retinopathy of prematurity and 128 (93%) of those had sufficient data (without missing or delayed exams) to determine age of onset of severe retinopathy of prematurity. Postmenstrual age at onset was 32.1 to 53.1 wks. In this referral center cohort, 1.4% (14/997) developed severe retinopathy of prematurity after discharge.
Our contemporary data support the 2013 AAP screening guidelines for ROP for infants 24 0/7 to 27 6/7 weeks gestational age.1 Some infants do not meet treatment criteria until after discharge home. Post-discharge follow-up of infants who are still at risk for severe ROP is crucial for timely detection and treatment.
PMCID: PMC3969774  PMID: 24503911
extremely premature infant
Pharmacists play an increasingly important role in medication therapy management, which requires communicating effectively with patients. Pharmacy students completed the Self-Assessment of Perceived Level of Cultural Competence (SAPLCC) questionnaire, and their results were used to identify patterns in self-assessment of cultural competence. In general, students rated their knowledge as less than their skills and attitudes. Important differences were found by race, comparing each group with its counterparts: African American students rated their perceived competencies regarding patient discrimination and barriers to health care at a significantly higher level; Asian American students rated their attitudes to engaging in self-reflection and their knowledge in multicultural issues at significantly lower level; and White students rated their awareness regarding racial dynamics at a significantly lower level. It is recommended to consider the students’ cultural, racial, and ethnic backgrounds before developing curriculum in cultural competence and, perhaps, to develop targeted educational interventions for specific groups.
PMCID: PMC4175523  PMID: 23395945
Cultural competence; pharmacy students; minority health care providers; training; assessment; racial dynamics; curriculum
Physical fitness testing is a common tool for motivating employees with strenuous occupations to reach and maintain a minimum level of fitness. Nevertheless, the use of such tests can be hampered by several factors, including required compliance with US antidiscrimination laws. The Highland Park (Texas) Department of Public Safety implemented testing in 1991, but no single test adequately evaluated its sworn employees, who are cross-trained and serve as police officers and firefighters. In 2010, the department's fitness experts worked with exercise physiologists from Baylor Heart and Vascular Hospital to develop and evaluate a single test that would be equitable regardless of race/ethnicity, disability, sex, or age >50 years. The new test comprised a series of exercises to assess overall fitness, followed by two sequences of job-specific tasks related to firefighting and police work, respectively. The study group of 50 public safety officers took the test; raw data (e.g., the number of repetitions performed or the time required to complete a task) were collected during three quarterly testing sessions. The statistical bootstrap method was then used to determine the levels of performance that would correlate with 0, 1, 2, or 3 points for each task. A sensitivity analysis was done to determine the overall minimum passing score of 17 points. The new physical fitness test and scoring system have been incorporated into the department's policies and procedures as part of the town's overall employee fitness program.
PMCID: PMC4059562  PMID: 24982558
Firefighters who have received an implantable cardioverter-defibrillator (ICD) are asked to retire or are permanently placed on restricted duty because of concerns about their being incapacitated by an ICD shock during a fire emergency. We present the case of a 40-year-old firefighter who, after surviving sudden cardiac arrest and undergoing ICD implantation, sought to demonstrate his fitness for active duty by completing a high-intensity, occupation-specific cardiac rehabilitation training program. The report details the exercise training, ICD monitoring, and stress testing that he underwent. During the post-training treadmill stress test in firefighter turnout gear, the patient reached a functional capacity of 17 metabolic equivalents (METs), exceeding the 12-MET level required for his occupation. He had no ICD shock therapy or recurrent sustained arrhythmias during stress testing or at any time during his cardiac rehabilitation stay. By presenting this case, we hope to stimulate further discussion about firefighters who have an ICD, can meet the functional capacity requirements of their occupation, and want to return to work.
PMCID: PMC4059573  PMID: 24982569
Nature immunology  2008;10(1):116-125.
A major challenge in vaccinology is to prospectively determine vaccine efficacy. Here we have used a systems biology approach to identify early gene ‘signatures’ that predicted immune responses in humans vaccinated with yellow fever vaccine YF-17D. Vaccination induced genes that regulate virus innate sensing and type I interferon production. Computational analyses identified a gene signature, including complement protein C1qB and eukaryotic translation initiation factor 2 alpha kinase 4—an orchestrator of the integrated stress response—that correlated with and predicted YF-17D CD8+ T cell responses with up to 90% accuracy in an independent, blinded trial. A distinct signature, including B cell growth factor TNFRS17, predicted the neutralizing antibody response with up to 100% accuracy. These data highlight the utility of systems biology approaches in predicting vaccine efficacy.
PMCID: PMC4049462  PMID: 19029902
Pediatrics  2013;131(6):e1865-e1873.
To investigate the relationships among blood pressure (BP) values, antihypotensive therapies, and in-hospital outcomes to identify a BP threshold below which antihypotensive therapies may be beneficial.
Prospective observational study of infants 230/7 to 266/7 weeks’ gestational age. Hourly BP values and antihypotensive therapy use in the first 24 hours were recorded. Low BP was investigated by using 15 definitions. Outcomes were examined by using regression analysis controlling for gestational age, the number of low BP values, and illness severity.
Of 367 infants enrolled, 203 (55%) received at least 1 antihypotensive therapy. Treated infants were more likely to have low BP by any definition (P < .001), but for the 15 definitions of low BP investigated, therapy was not prescribed to 3% to 49% of infants with low BP and, paradoxically, was administered to 28% to 41% of infants without low BP. Treated infants were more likely than untreated infants to develop severe retinopathy of prematurity (15% vs 8%, P = .03) or severe intraventricular hemorrhage (22% vs 11%, P < .01) and less likely to survive (67% vs 78%, P = .02). However, with regression analysis, there were no significant differences between groups in survival or in-hospital morbidity rates.
Factors other than BP contributed to the decision to use antihypotensive therapies. Infant outcomes were not improved with antihypotensive therapy for any of the 15 definitions of low BP investigated.
PMCID: PMC3666108  PMID: 23650301
extremely preterm infant; antihypotensive therapy; blood pressure; hypotension
As resident attrition disrupts educational and workload balance and reduces the number of graduating physicians to care for patients, an ongoing goal of graduate medical education programs is to retain residents.
We compared annual rates of resident attrition in obstetrics and gynecology (Ob-Gyn) with other clinical specialties of similar or larger size during a recent 10-year period, and explored the reasons for resident attrition.
In this observational study, we analyzed annual data from the American Medical Association Graduate Medical Education Census between academic years 2000 and 2009 for residents who entered Ob-Gyn and other core clinical specialties. Our primary outcome was the trend in averaged annual attrition rates.
The average annual attrition was 196 ± 12 (SD) residents, representing 4.2% ± 0.5% of all Ob-Gyn residents. Rates of attrition were consistently higher among men (5.3%) and international medical school graduates (7.6%). The annual rate of attrition was similar to that for other clinical specialties (mean: 4.0%; range: from 1.5% in emergency medicine to 7.9% in psychiatry). The attrition rates for Ob-Gyn residents were relatively stable for the 10-year period (range: 3.6% in 2008 to 5.1% in 2006). Common reasons for attrition were transition to another specialty (30.0%), withdrawal/dismissal (28.2%), transfer to another Ob-Gyn program (25.4%), and leave of absence (2.2%). These proportions remained fairly constant during this 10-year period.
The average annual attrition rate of residents in Ob-Gyn was 4.2%, comparable to most other core clinical specialties.
PMCID: PMC3693692  PMID: 24404271
Objective. To evaluate the efficacy of faculty-led problem-based learning (PBL) vs online simulated-patient case in fourth-year (P4) pharmacy students.
Design. Fourth-year pharmacy students were randomly assigned to participate in either online branched-case learning using a virtual simulation platform or a small-group discussion. Preexperience and postexperience student assessments and a survey instrument were completed.
Evaluation. While there were no significant differences in the preexperience test scores between the groups, there was a significant increase in scores in both the virtual-patient group and the PBL group between the preexperience and postexperience tests. The PBL group had higher postexperience test scores (74.8±11.7) than did the virtual-patient group (66.5±13.6) (p=0.001).
Conclusion. The PBL method demonstrated significantly greater improvement in postexperience test scores than did the virtual-patient method. Both were successful learning methods, suggesting that a diverse approach to simulated patient cases may reach more student learning styles.
PMCID: PMC4028585  PMID: 24850938
virtual patient; simulation; problem-based learning; pharmacy education
The Journal of pediatrics  2012;162(4):685-690.e1.
To test the hypothesis that high-risk ventilator-dependent extremely low birth weight (ELBW; BW ≤1000g) infants treated with seven days of hydrocortisone will have larger total brain tissue volumes than placebo treated infants.
Study design
A predetermined sample size of 64 ELBW infants, between 10 to 21 days old and ventilator-dependent with a respiratory index score ≥2, were randomized to systemic hydrocortisone (17 mg/kg cumulative dose) or saline placebo. Primary outcome was total brain tissue volume. Volumetric MRI was performed at 38 weeks postmenstrual age; brain tissue regions were segmented and quantified automatically with a high degree of accuracy and nine structures were segmented manually. All analyses of regional brain volumes were adjusted by postmenstrual age at MRI scan.
The study groups were similar at baseline and eight infants died in each arm. Unadjusted total brain tissue volume (mean±SD) in the hydrocortisone (N=23) and placebo treated infants (N=21) was 272±40.3 cm3 and 277.8±59.1 cm3, respectively (adjusted mean difference: 6.35 cm3 (95% CI: (−20.8, 32.5); P=0.64). Three of the 31 hydrocortisone treated infants and five of the 33 placebo treated infants survived without severe BPD (RR 0.62, 95% CI: 0.13, 2.66; P=0.49). No significant differences were noted in pre-specified secondary outcomes of regional structural volumes or days on respiratory support. No adverse effects of hydrocortisone were observed.
Low dose hydrocortisone in high-risk ventilator-dependent infants after a week of age had no discernible effect on regional brain volumes or pulmonary outcomes prior to NICU discharge.
PMCID: PMC3609889  PMID: 23140612
Bronchopulmonary dysplasia; corticosteroids; extremely low birth weight; magnetic resonance imaging; brain injury; mechanical ventilation
Engaging community residents to obtain their feedback in conducting clinical research, and including them as leaders in implementing applicable health advances is crucial for success and sustaining large center awards.
Forty-four adult men and women participated in one of four focus groups. Two groups each (one African American and one Caucasian) were conducted in Baton Rouge and in New Orleans.
In an effort to determine the knowledge, attitudes, and beliefs Louisiana residents have about the Louisiana Clinical and Translational Science (LA CaTS) Center concept, four main themes emerged from focus group participants concerning the state’s research institutions, and what it means to have these institutions operating under one umbrella to improve the quality of health of its people: 1) academic/research institutions of the State are uniformly widely recognized and held in high regard; 2) increasing awareness of clinical research is a necessity; 3) establishing the LA CaTS Center is an excellent idea; and 4) effective communication including delivery style is crucial to partnerships and especially to the community.
Focus group discussions can provide insight into community residents’ perceptions, beliefs, motivations and patterns of behavior for strategically planning for large center awards.
PMCID: PMC3971466  PMID: 24138681
Research; Partnerships
The Journal of Pediatrics  2012;161(2):264-269.e2.
To assess the impact of emperic antifungal therapy of invasive candidiasis on subsequent outcomes in premature infants.
Study design
This was a cohort study of infants ≤1000 g birth weight cared for at Neonatal Research Network sites. All infants had at least 1 positive culture for Candida. Emperic antifungal therapy was defined as receipt of a systemic antifungal on the day of or the day before the first positive culture for Candida was drawn. We created Cox proportional hazards and logistic regression models stratified on propensity score quartiles to determine the effect of emperic antifungal therapy on survival, time to clearance of infection, retinopathy of prematurity, bronchopulmonary dysplasia, end-organ damage, and neurodevelopmental impairment (NDI).
136 infants developed invasive candidiasis. The incidence of death or NDI was lower for infants who received emperic antifungal therapy (19/38, 50%) compared with those who had not (55/86, 64%; odds ratio=0.27 [95% confidence interval 0.08–0.86]). There was no significant difference between the groups for any single outcome or other combined outcomes.
Emperic antifungal therapy was associated with increased survival without NDI. A prospective randomized trial of this strategy is warranted.
PMCID: PMC3380169  PMID: 22424952
Candida; neonate; mortality; neurodevelopmental impairment
PLoS ONE  2013;8(5):e62804.
Our objective was to investigate diverse clinical antecedents of total and regional brain volume abnormalities and white matter hyperintensity volume on term MRI in extremely low birth weight (birth weight ≤1000 g) survivors. A consecutive cohort of extremely low birth weight infants who survived to 38 weeks postmenstrual age (n = 122) and a control group of 16 healthy term newborns underwent brain MRI at term-equivalent age. Brain volumes were measured using semi-automated and manual segmentation methods. Using multivariable linear regression, clinical antecedents were correlated with volumes of total brain tissue, white matter hyperintensities, and regional tissues/structures, adjusted for age at MRI, total cranial volume, and total tissue volume. Regional brain volumes were markedly reduced in extremely low birth weight infants as compared to term newborns (relative difference range: −11.0%, −35.9%). Significant adverse clinical associations for total brain tissue volume included: small for gestational age, seizures, caffeine therapy/apnea of prematurity, duration of parenteral nutrition, pulmonary hemorrhage, and white matter injury (p<0.01 for each; relative difference range: −1.4% to −15.0%). Surgery for retinopathy of prematurity and surgery for necrotizing enterocolitis or spontaneous intestinal perforation were significantly associated with increasing volume of white matter hyperintensities. Regional brain volumes are sensitive to multiple perinatal factors and neonatal morbidities or interventions. Brain growth measurements in extremely low birth weight infants can advance our understanding of perinatal brain injury and development.
PMCID: PMC3650008  PMID: 23671636
Current guidelines, initially published in 1995, recommend antenatal corticosteroids for mothers with preterm labor from 24–34 weeks gestational age, but not before 24 weeks because of lack of data. However, many infants born before 24 weeks are provided intensive care now.
To determine if antenatal corticosteroids are associated with improvement in major outcomes in infants born at 22 and 23 weeks.
Design, Setting, Participants
Data for this cohort study were collected prospectively on 401–1000 gram inborn infants (N=10,541) of 22–25 weeks gestation born between 1993–2009 at 23 academic perinatal centers in the United States. Certified examiners unaware of exposure to antenatal corticosteroids performed follow-up examinations on 4,924 (86.5%) of the infants born in 1993–2008 who survived to 18–22 months. Logistic regression models generated adjusted odds ratios, controlling for maternal and neonatal variables.
Main Outcome Measures
Mortality and neurodevelopmental impairment at 18–22 months corrected age
Death or neurodevelopmental impairment at 18–22 months was lower for infants whose mothers received antenatal corticosteroids born at 23 weeks (antenatal corticosteroids, 83.4% vs no antenatal corticosteroids, 90.5%; adjusted odds ratio 0.58; 95% CI, 0.42–0.80), at 24 weeks (antenatal corticosteroids, 68.4% vs no antenatal corticosteroids, 80.3%; adjusted odds ratio 0.62; 95% CI, 0.49–0.78), and at 25 weeks (antenatal corticosteroids, 52.7% vs no antenatal corticosteroids, 67.9%; adjusted odds ratio 0.61; 95% CI, 0.50–0.74) but not at 22 weeks (antenatal corticosteroids, 90.2% vs no antenatal corticosteroids, 93.1%; adjusted odds ratio 0.80; 95% CI, 0.29–12.21). Death by 18–22 months, hospital death, death/intraventricular hemorrhage/periventricular leukomalacia, and death/necrotizing enterocolitis were significantly lower for infants born at 23, 24, and 25 weeks gestational age if the mothers had received antenatal corticosteroids but the only outcome significantly lower at 22 weeks was death/necrotizing enterocolitis (antenatal corticosteroids, 73.5% vs no antenatal corticosteroids, 84.5%; adjusted odds ratio 0.54; 95% CI, 0.30–0.97).
Among infants born at 23–25 weeks gestation, use of antenatal corticosteroids compared to non-use was associated with a lower rate of death or neurodevelopmental impairment at 18–22 months.
PMCID: PMC3565238  PMID: 22147379
prematurity; infant mortality; neonatal intensive care; neurodevelopmental impairment; lung maturation; limits of viability

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