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543 results on '"Greenberg, Rachel G."'

14. Neonatal Morbidities, Neurodevelopmental Impairments, and Positive Health among Children Surviving Birth before 32 Weeks of Gestation

Author

Teitelbaum, S.L., Stroustrup, A., Merhar, S., Lampland, A., Reynolds, A., Pryhuber, G., Moore, P., Washburn, L., Carter, B., Pastyrnak, S., Neal, C., Smith, L., Helderman, J., Vaidya, R., Obeid, R., Rollins, C., Bear, K., Lenski, M., Singh, R., Msall, M., Frazier, J., Gogcu, S., Montgomery, A., Kuban, K., Douglass, L., Jara, H., Joseph, R., Logan, J. Wells, Tang, Xiaodan, Greenberg, Rachel G., Smith, Brian, Jacobson, Lisa, Blackwell, Courtney K., Hudak, Mark, Aschner, Judy L., Lester, Barry, and O'Shea, T. Michael

Published
2025
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21. Paradoxical Antibiotic Effect of Ampicillin: Use of a Population Pharmacokinetic Model to Evaluate a Clinical Correlate of the Eagle Effect in Infants With Bacteremia.

Author

Ericson, Jessica E, Hornik, Christoph P, Greenberg, Rachel G, Clark, Reese H, Tremoulet, Adriana H, Le, Jennifer, Cohen-Wolkowiez, Michael, Smith, P Brian, and Benjamin, Daniel K

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Hematology, Biodefense, Pediatric, Vaccine Related, Prevention, Sepsis, Infectious Diseases, Infection, Ampicillin, Anti-Bacterial Agents, Bacteremia, Dose-Response Relationship, Drug, Female, Gestational Age, Humans, Infant, Newborn, Logistic Models, Male, Microbial Sensitivity Tests, Models, Theoretical, Poisson Distribution, enterococcus, group B streptococcus, Escherichia coli, exposure, dosing, Best Pharmaceuticals for Children Act – Pediatric Trials Network, Paediatrics and Reproductive Medicine, Public Health and Health Services, Pediatrics, Clinical sciences, Paediatrics
Abstract

BackgroundHigh doses of ampicillin are often used to achieve therapeutic drug concentrations in infants. A paradoxical antibiotic effect, often called the Eagle effect, occurs when increasing concentrations of antibiotic above a threshold results in decreased efficacy. It is unknown if infants treated with ampicillin are at risk for this paradoxical effect.MethodsWe identified infants MIC) and PK parameters using separate logistic regression models. Adjusted logistic regression and Poisson models were used to calculate the odds of prolonged bacteremia ≥3 days and the duration of bacteremia, respectively, for dose, T > MIC and multiple PK parameters.ResultsAmong 1272 infants meeting inclusion criteria, odds of death 7 or 30 days after the positive blood culture were not consistent with a paradoxical effect across any of the dosing regimens or PK parameters evaluated. The odds of prolonged bacteremia was lowest at the lowest dose category and the lowest daily dose category but not associated with the area-under-the-concentration time curve from 0 to 24 hours, or the maximum or minimum concentrations at steady state. T > MIC of ≥50% of the dosing interval was associated with decreased duration of bacteremia and odds of prolonged bacteremia.ConclusionsIt is unlikely that a paradoxical antibiotic effect will have a clinical correlate when ampicillin is used for neonatal bacteremia. A T > MIC ≥50% decreased both duration of bacteremia and odds of prolonged bacteremia.

Published
2020

24. Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience

Author

Boutzoukas, Angelique E., Olson, Rachel, Sellers, Mary Ann, Fischer, Gwenyth, Hornik, Chi D., Alibrahim, Omar, Iheagwara, Kelechi, Abulebda, Kamal, Bass, Andora L., Irby, Katherine, Subbaswamy, Anjali, Zivick, Elizabeth E., Sweney, Jill, Stormorken, Anne G., Barker, Erin E., Lutfi, Riad, McCrory, Michael C., Costello, John M., Ackerman, Kate G., Munoz Pareja, Jennifer C., Dean, J. Michael, Abdelsamad, Nael, Hanley, Daniel F., Jr, Mould, W. Andrew, Lane, Karen, Stroud, Mary, Feger, Bryan J., Greenberg, Rachel G., Smith, P. Brian, Benjamin, Daniel K., Jr, Hornik, Christoph P., Zimmerman, Kanecia O., and Becker, Mara L.

Published
2023
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26. Prolonged duration of early antibiotic therapy in extremely premature infants

Author

Greenberg, Rachel G, Chowdhury, Dhuly, Hansen, Nellie I, Smith, P Brian, Stoll, Barbara J, Sánchez, Pablo J, Das, Abhik, Puopolo, Karen M, Mukhopadhyay, Sagori, Higgins, Rosemary D, and Cotten, C Michael

Subjects
Paediatrics, Biomedical and Clinical Sciences, Perinatal Period - Conditions Originating in Perinatal Period, Preterm, Low Birth Weight and Health of the Newborn, Pediatric, Infant Mortality, Infectious Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Infection, Reproductive health and childbirth, Good Health and Well Being, Anti-Bacterial Agents, Female, Humans, Infant, Extremely Premature, Infant, Newborn, Male, Retrospective Studies, United States, Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network, Paediatrics and Reproductive Medicine, Public Health and Health Services, Pediatrics
Abstract

BackgroundProlonged early antibiotics in extremely premature infants may have negative effects. We aimed to assess prevalence and outcomes of provision of prolonged early antibiotics to extremely premature infants in the absence of culture-confirmed infection or NEC.MethodsCohort study of infants from 13 centers born without a major birth defect from 2008-2014 who were 401-1000 grams birth weight, 22-28 weeks gestation, and survived ≥5 days without culture-confirmed infection, NEC, or spontaneous intestinal perforation. We determined the proportion of infants who received prolonged early antibiotics, defined as ≥5 days of antibiotic therapy started at ≤72 h of age, by center and over time. Associations between prolonged early antibiotics and adverse outcomes were assessed using multivariable logistic regression.ResultsA total of 5730 infants were included. The proportion of infants receiving prolonged early antibiotics varied from 30-69% among centers and declined from 49% in 2008 to 35% in 2014. Prolonged early antibiotics was not significantly associated with death (adjusted odds ratio 1.17 [95% CI: 0.99-1.40], p = 0.07) and was not associated with NEC.ConclusionsThe proportion of extremely premature infants receiving prolonged early antibiotics decreased, but significant center variation persists. Prolonged early antibiotics were not significantly associated with increased odds of death or NEC.

Published
2019

33. Perceived barriers to pediatrician and family practitioner participation in pediatric clinical trials: Findings from the Clinical Trials Transformation Initiative

Author

Greenberg, Rachel G, Corneli, Amy, Bradley, John, Farley, John, Jafri, Hasan S, Lin, Li, Nambiar, Sumathi, Noel, Gary J, Wheeler, Chris, Tiernan, Rosemary, Smith, P Brian, Roberts, Jamie, and Benjamin, Daniel K

Subjects
Clinical Trials and Supportive Activities, Pediatric, Clinical Research, Pediatric Research Initiative, Management of diseases and conditions, 7.1 Individual care needs, Pediatric clinical trials, Enrollment, Provider referral, Practitioner referral, ABDD, AAP, American Academy of Pediatrics, ABDD, antibacterial drug development, CTTI, Clinical Trials Transformation Initiative, FDA, Food and Drug Administration, NIH, National Institutes of Health, Peds ABDD, Clinical Trials Transformation Initiative Pediatric Trials in Antibacterial Drug Development, US, United States
Abstract

Despite legislation to stimulate pediatric drug development through clinical trials, enrolling children in trials continues to be challenging. Non-investigator (those who have never served as a clinical trial investigator) providers are essential to recruitment of pediatric patients, but little is known regarding the specific barriers that limit pediatric providers from participating in and referring their patients to clinical trials. We conducted an online survey of pediatric providers from a wide variety of practice types across the United States to evaluate their attitudes and awareness of pediatric clinical trials. Using a 4-point Likert scale, providers described their perception of potential barriers to their practice serving as a site for pediatric clinical trials. Of the 136 providers surveyed, 52/136 (38%) had previously referred a pediatric patient to a trial, and only 17/136 (12%) had ever been an investigator for a pediatric trial. Lack of awareness of existing pediatric trials was a major barrier to patient referral by providers, in addition to consideration of trial risks, distance to the site, and time needed to discuss trial participation with parents. Overall, providers perceived greater challenges related to parental concerns and parent or child logistical barriers than study implementation and ethics or regulatory barriers as barriers to their practice serving as a trial site. Providers who had previously been an investigator for a pediatric trial were less likely to be concerned with potential barriers than non-investigators. Understanding the barriers that limit pediatric providers from collaboration or inhibit their participation is key to designing effective interventions to optimize pediatric trial participation.

Published
2018

34. Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative

Author

Greenberg, Rachel G, Gamel, Breck, Bloom, Diane, Bradley, John, Jafri, Hasan S, Hinton, Denise, Nambiar, Sumathi, Wheeler, Chris, Tiernan, Rosemary, Smith, P Brian, Roberts, Jamie, and Benjamin, Daniel K

Subjects
Biomedical and Clinical Sciences, Clinical Research, Clinical Trials and Supportive Activities, Pediatric, Patient Safety, Generic health relevance, Pediatric clinical trials, Interview, Antibacterial, Parental consent, Recruitment, ABDD, ABDD Peds Trials, Clinical Trials Transformation Initiative ABDD Pediatric Trials, ABDD, antibacterial drug development, ADHD, attention-deficit/hyperactivity disorder, FDA, Food and Drug Administration, HPV, human papillomavirus, IRB, Institutional Review Board, MRI, magnetic resonance imaging, NICHD, National Institute for Child Health and Human Development, NIH, National Institutes of Health, Biomedical and clinical sciences
Abstract

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Published
2018

47. Outcomes of Moderately Preterm Infants of Insulin-Dependent Diabetic Mothers.

Author

Gray, Keyaria D., Saha, Shampa, Battarbee, Ashley N., Cotten, Charles Michael, Boghossian, Nansi S., Walsh, Michele C., and Greenberg, Rachel G.

Subjects
TYPE 1 diabetes, RISK assessment, CONTINUOUS positive airway pressure, POISSON distribution, HOSPITAL birthing centers, T-test (Statistics), RESEARCH funding, GESTATIONAL diabetes, PREMATURE infant diseases, PATENT ductus arteriosus, FISHER exact test, KRUSKAL-Wallis Test, INSULIN, PREGNANCY outcomes, RELATIVE medical risk, CHI-squared test, DESCRIPTIVE statistics, HOSPITAL care of newborn infants, LONGITUDINAL method, RESEARCH, LENGTH of stay in hospitals, CONFIDENCE intervals, DATA analysis software, COMPARATIVE studies, REGRESSION analysis, DISEASE risk factors, DISEASE complications
Abstract

Objective Little is known about the hospital outcomes of moderately preterm (MPT; 29 0/7–33 6/7 weeks gestational age) infants born to insulin-dependent diabetic mothers (IDDMs). We evaluated characteristics and outcomes of MPT infants born to IDDMs compared with those without IDDM (non-IDDM). Study Design Cohort study of infants from 18 centers included in the MPT infant database from 2012 to 2013. We compared characteristics and outcomes of infants born to IDDMs and non-IDDMs. Results Of 7,036 infants, 527 (7.5%) were born to IDDMs. Infants of IDDMs were larger at birth, more often received continuous positive pressure ventilation in the delivery room, and had higher risk of patent ductus arteriosus (adjusted relative risk or aRR: 1.49, 95% confidence interval [CI]: 1.20–1.85) and continued hospitalization at 40 weeks postmenstrual age (aRR: 1.55, 95% CI: 1.18–2.05). Conclusion MPT infants of IDDM received more respiratory support and prolonged hospitalizations, providing further evidence of the important neonatal health consequences of maternal diabetes. Key Points Little data are available on moderate preterm infants of IDDMs. MPT infants of IDDMs need more respiratory support. Longer neonatal intensive care unit stays among MPT infants of IDDMs. [ABSTRACT FROM AUTHOR]

Published
2024
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