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1. The Impact of Erythropoietin on Short- and Long-Term Kidney-Related Outcomes in Neonates of Extremely Low Gestational Age. Results of a Multicenter, Double-Blind, Placebo-Controlled Randomized Clinical Trial

Author

David J. Askenazi, Patrick J. Heagerty, Robert H. Schmicker, Patrick Brophy, Sandra E. Juul, Stuart L. Goldstein, Sangeeta Hingorani, Bryan A. Comstock, Rajan Wadhawan, Dennis E. Mayock, Sherry E. Courtney, Tonya Robinson, Kaashif A. Ahmad, Ellen Bendel-Stenzel, Mariana Baserga, Edmund F. LaGamma, L. Corbin Downey, Raghavendra Rao, Nancy Fahim, Andrea Lampland, Ivan D. Frantz, Janine Y. Khan, Michael Weiss, Maureen M. Gilmore, Robin Ohls, Nishant Srinivasan, Jorge E. Perez, Victor McKay, Phuong T. Vu, Billy Thomas, Nahed Elhassan, Sarah Mulkey, Philip Dydynski, Vivek K. Vijayamadhavan, Neil Mulrooney, Bradley Yoder, Jordan S. Kase, Jennifer Check, Semsa Gogcu, Erin Osterholm, Sara Ramel, Catherine Bendel, Cheryl Gale, Thomas George, Michael Georgieff, Tate Gisslen, Sixto Guiang, Anne Hall, Dana Johnson, Katie Pfister, Heather Podgorski, Kari Roberts, Erin Stepka, Melissa Engel, Heidi Kamrath, Johannah Scheurer, Angela Hanson, Katherine Satrom, Susan Pfister, Ann Simones, Erin Plummer, Elizabeth Zorn, Camilia R. Martin, Deirdre O'Reilly, Nicolas Porta, Catalina Bazacliu, Jonathan Williams, Dhanashree Rajderkar, Frances Northington, Raul Chavez Valdez, Sandra Beauman, Patel Saurabhkumar, Magaly Diaz-Barbosa, Arturo Serize, Jorge Jordan, Debbie Ott, Ariana Franco Mora, Pamela Hedrick, Vicki Flynn, Amy Silvia, Bailey Clopp, John B. Feltner, Isabella Esposito, Stephanie Hauge, Samantha Nikirk, Andrea Purnell, Emilie Loy, Natalie Sikes, Melanie Mason, Jana McConnell, Tiffany Brown, Henry Harrison, Denise Pearson, Tammy Drake, Jocelyn Wright, Debra Walden, Annette Guy, Jennifer Nason, Morgan Talbot, Kristen Lee, Sarah Penny, Terri Boles, Melanie Drummond, Katy Kohlleppel, Charmaine Kathen, Brian Kaletka, Shania Gonzales, Cathy Worwa, Molly Fisher, Tyler Richter, Alexander Ginder, Brixen Reich, Carrie Rau, Manndi Loertscher, Laura Bledsoe, Kandace McGrath, Kimberlee Weaver Lewis, Jill Burnett, Susan Schaefer, Karie Bird, Clare Giblin, Rita Daly, Kristi Lanier, Kelly Warden, Jenna Wassenaar, Jensina Ericksen, Bridget Davern, Mary Pat Osborne, Brittany Gregorich, Neha Talele, Evelyn Obregon, Tiglath Ziyeh, Molly Clarke, Rachel E. Wegner, Palak Patel, Molly Schau, Annamarie Russow, Kelly Curry, Susan Sinnamon, Lisa Barnhart, Charlamaine Parkinson, Mary Hanson, Elizabeth Kuan, Conra Backstrom Lacy, Edshelee M. Galvis, Susana Bombino, Denise Martinez, Suzi Bell, Corrie Long, Cathy Longa, Michael Westerveld, Stacy McConkey, Anne Hay, Niranjana Natarajan, Shari Gaudette, Sarah Cobb, Gregory Sharp, Elizabeth Schumacher, Leslie Schuschke, Charlotte Frey, Mario Fierro, Lois Gilmore, Pamela Lundequam, Ronald Hoekstra, Anastasia Ketko, Nina Perdue, Sean Cunningham, Kelly Stout, Becky Hall, Galina Morshedzadeh, Betsy Ostrander, Sarah Winter, Lauren Cox, Matthew A. Rainaldi, Sarah Hensley, Melissa Morris, Dia Roberts, Melissa Tuttle, Christopher Boys, Solveig Hultgren, Elizabeth I. Pierpont, Tom George, Kelly E. King, Katherine Bataglia, Cathy Neis, Mark Bergeron, Cristina Miller, Cara Accomando, Jennifer Anne Gavin, Elizabeth Maczek, Susan Marakovitz, Aimee Knorr, Vincent C. Smith, Jane E. Stewart, Marie Weissbourd, Raye-Ann deRegnier, Nana Matoba, Shelly C. Heaton, Erika M. Cascio, Janet Brady, Suman Ghosh, Jessica Ditto, Mary Leppert, Jean Lowe, Janell Fuller, Tara DuPont, Pamela Kloska, Saurabh Patel, Lauren Carbonell, Anna Maria Patino-Fernandez, Carmen de Lerma, Kelly McDonough, Maiana De Cortada, Lacy Chavis, Jane Shannon, Mark A. Konodi, Christopher Nefcy, Karl C.K. Kuban, Jean R. Lowe, T. Michael O'Shea, Manjiri Dighe, Todd Richards, Dennis W.W. Shaw, Colin Studholme, Christopher M. Traudt, Roberta Ballard, Adam Hartman, Scott Janis, T. Robin Ohls, Michael O'Shea, Ronnie Guillet, M. Bethany Ball, Hannah Glass, Ben Saville, and Michael Schreiber

Subjects
Male, medicine.medical_specialty, Renal function, Gestational Age, Infant, Premature, Diseases, Placebo, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, 030225 pediatrics, Internal medicine, medicine, Albuminuria, Humans, 030212 general & internal medicine, Renal Insufficiency, Chronic, Erythropoietin, business.industry, Acute kidney injury, Infant, Newborn, Gestational age, Acute Kidney Injury, medicine.disease, Recombinant Proteins, Blood pressure, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Hypertension, Female, medicine.symptom, business, medicine.drug, Glomerular Filtration Rate
Abstract

OBJECTIVE: To evaluate whether extremely low gestational age neonates (ELGANs) randomized to erythropoietin have better or worse kidney-related outcomes during hospitalization and at 22–26 months corrected gestational age (cGA) compared with those randomized to placebo. STUDY DESIGN: We performed an ancillary study to a multicenter double-blind, placebo-controlled randomized clinical trial of erythropoietin in ELGANs. RESULTS: The prevalence of severe (stage 2 or 3) acute kidney injury (AKI) was 18.2%. We did not find a statistically significant difference between those randomized to erythropoietin vs. placebo for in-hospital primary (severe AKI) or secondary outcomes (any AKI and serum creatinine [SCr]/ cystatin C values at days 0, 7, 9 and 14). At 22–26 months cGA, 16% of the cohort had an estimated glomerular filtration rate (eGFR) 30 mg/g, 23% had a systolic blood pressure (SBP) >95(th) percentile for age, and 40% had a diastolic blood pressure (DBP) >95(th) percentile for age. SBP >90(th) percentile occurred less often among recipients of erythropoietin (p95(th) percentile or DBP >90(th) or >95(th) percentiles. CONCLUSIONS: ELGANs have high rates of in-hospital AKI and kidney-related problems at 22–26 months cGA. Recombinant erythropoietin (rhEpo) may protect ELGANs against long-term elevated SBP, but does not appear to protect from AKI, low eGFR, albuminuria or elevated DBP at 22–26 months cGA.

Published
2020

2. Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320)

Author

Stellan Håkansson, Susan W. Aucott, Joseph W. Kaempf, Omer Erdeve, Aijaz Farooqi, Denise C Hassinger, William A. Carey, Meera Sankar, Kelly Nelson, Amy Kimball, Anup Katheria, Anne Marie Heuchan, Jason Sauberan, Jorge Perez, Madoka Hayashi, Johanna Lindqvist, Tina A. Leone, Arturo Serize, Melissa Liebowitz, Jaideep K Singh, Lawrence Dong, Andrea C. Wickremasinghe, Ronald I. Clyman, Ali Bulbul, Ilene Sue Wolf, and Matthew Derrick

Subjects
Male, Indomethacin, Administration, Oral, Ibuprofen, Conservative Treatment, Pediatrics, 0302 clinical medicine, Secondary analysis, Ductus arteriosus, Medicine, 030212 general & internal medicine, Ductus Arteriosus, Patent, Initial rate, Obstetrics and Gynecology, 3. Good health, medicine.anatomical_structure, Treatment Outcome, Anesthesia, Infant, Extremely Premature, Administration, cardiovascular system, Administration, Intravenous, Patent, Female, medicine.symptom, Intravenous, medicine.drug, Oral, Clinical Sciences, Extremely Premature, Article, Constriction, Paediatrics and Reproductive Medicine, 03 medical and health sciences, Drug treatment, 030225 pediatrics, Humans, Acetaminophen, business.industry, organic chemicals, Infant, Newborn, Infant, Ductus Arteriosus, Newborn, Vasoconstriction, Pediatrics, Perinatology and Child Health, San Francisco, business
Abstract

ObjectiveTo evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns

Published
2019

3. Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial

Author

Anup Katheria, Jorge Perez, Ilene Sue Wolf, Denise C Hassinger, Amy Kimball, Anne Marie Heuchan, Erika Fernandez, Jaideep K Singh, Kelly Nelson, Arturo Serize, Andrea C. Wickremasinghe, Susan W. Aucott, William A. Carey, Joseph W. Kaempf, Meera Sankar, Lawrence Dong, Pda-Tolerate Trial Investigators, Melissa Liebowitz, Matthew Derrick, Jason Sauberan, Ronald I. Clyman, and Ali Bulbul

Subjects
Male, Pediatrics, health care facilities, manpower, and services, Diseases, Infant, Premature, Diseases, 0302 clinical medicine, Ductus arteriosus, Multicenter Studies as Topic, 030212 general & internal medicine, Prospective Studies, Ductus Arteriosus, Patent, Bronchopulmonary Dysplasia, Randomized Controlled Trials as Topic, Pediatric, premature birth, medicine.anatomical_structure, Treatment Outcome, Premature birth, Research Design, Infant, Extremely Premature, Patent, Female, Maternal Age, Risk, medicine.medical_specialty, congenital, hereditary, and neonatal diseases and abnormalities, Clinical Trials and Supportive Activities, education, Extremely Premature, TOLEave it alone or Respond And Treat Early) Trial Investigators [PDA-TOLERATE (PDA], Drug Administration Schedule, Article, Paediatrics and Reproductive Medicine, patent ductus arteriosus, 03 medical and health sciences, Clinical Research, 030225 pediatrics, health services administration, bronchopulmonary dysplasia, medicine, Humans, cardiovascular diseases, Trial registration, Premature, business.industry, Patient Selection, Low Birth Weight, Infant, Newborn, Infant, Ductus Arteriosus, Human Movement and Sports Sciences, Infant, Low Birth Weight, Newborn, medicine.disease, Good Health and Well Being, Bronchopulmonary dysplasia, Pediatrics, Perinatology and Child Health, business
Abstract

The PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants

Published
2019

4. Prolonged Tracheal Intubation and the Association Between Patent Ductus Arteriosus and Bronchopulmonary Dysplasia: A Secondary Analysis of the PDA-TOLERATE trial

Author

Ronald I. Clyman, Joseph Kaempf, Melissa Liebowitz, Omer Erdeve, Ali Bulbul, Stellan Håkansson, Johanna Lindqvist, Aijaz Farooqi, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly Nelson, Andrea Wickremasinghe, Lawrence Dong, Denise C. Hassinger, Susan W. Aucott, Madoka Hayashi, Anne Marie Heuchan, William A. Carey, Matthew Derrick, Erika Fernandez, Meera Sankar, Tina Leone, Jorge Perez, Arturo Serize, Scott Fields, Lora Whitten, Stefanie Rogers, Emel Okulu, Gaffari Tunc, Tayfun Ucar, Ebru Türkoglu Ünal, Jane Steen, Kathy Arnell, Sarah Holtschlag, Michael Schreiber, Caryn Peters, Maureen Gilmore, Lorna McKay, Dianne Carole, Annette Shaw, Malinda Harris, Amy Amsbaugh, Lavonne M. Liedl, Sue Wolf, Avi Groner, Amy Kimball, Jae Kim, Renee Bridge, Ellen Knodel, Chrissy Weng, Magaly Diaz Barbosa, Richard Polin, Marilyn Weindler, Shahab Noori, Jeffrey Reese, and Yao Sun

Subjects
Male, Time Factors, health care facilities, manpower, and services, medicine.medical_treatment, Cardiovascular, Low Birth Weight and Health of the Newborn, Severity of Illness Index, Pediatrics, 0302 clinical medicine, Ductus arteriosus, Secondary analysis, Infant Mortality, Prospective Studies, 030212 general & internal medicine, Ductus Arteriosus, Patent, Lung, Bronchopulmonary Dysplasia, Pediatric, Respiration, premature birth, medicine.anatomical_structure, Premature birth, Anesthesia, Artificial, Patent, Female, congenital, hereditary, and neonatal diseases and abnormalities, education, PDA-TOLERATE Trial Investigators, Neonatal Respiratory Distress, Paediatrics and Reproductive Medicine, patent ductus arteriosus, 03 medical and health sciences, Preterm, health services administration, 030225 pediatrics, bronchopulmonary dysplasia, Intubation, Intratracheal, medicine, Humans, cardiovascular diseases, business.industry, Prevention, Tracheal intubation, Infant, Newborn, Infant, Ductus Arteriosus, Human Movement and Sports Sciences, Perinatal Period - Conditions Originating in Perinatal Period, Newborn, medicine.disease, Respiration, Artificial, Intratracheal, Good Health and Well Being, Increased risk, Bronchopulmonary dysplasia, Pediatrics, Perinatology and Child Health, Intubation, business
Abstract

In the PDA-TOLERATE trial, persistent (even for several weeks) moderate to large patent ductus arteriosus (PDA) was not associated with an increased risk of BPD when the infant required

Published
2021
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5. PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age

Author

Ronald I. Clyman, Melissa Liebowitz, Joseph Kaempf, Omer Erdeve, Ali Bulbul, Stellan Håkansson, Johanna Lindqvist, Aijaz Farooqi, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly Nelson, Andrea Wickremasinghe, Lawrence Dong, Denise C. Hassinger, Susan W. Aucott, Madoka Hayashi, Anne Marie Heuchan, William A. Carey, Matthew Derrick, Erika Fernandez, Meera Sankar, Tina Leone, Jorge Perez, Arturo Serize, Scott Fields, Lora Whitten, Stefanie Rogers, Emel Okulu, Gaffari Tunc, Tayfun Ucar, Ebru Türkoglu Ünal, Jane Steen, Kathy Arnell, Sarah Holtschlag, Michael Schreiber, Caryn Peters, Maureen Gilmore, Lorna McKay, Dianne Carole, Annette Shaw, Malinda Harris, Amy Amsbaugh, Lavonne M. Liedl, Sue Wolf, Avi Groner, Amy Kimball, Jae Kim, Renee Bridge, Ellen Knodel, Chrissy Weng, Magaly Diaz Barbosa, Richard Polin, Marilyn Weindler, Shahab Noori, Jeffrey Reese, and Yao Sun

Subjects
Male, medicine.medical_treatment, Indomethacin, Ibuprofen, Reproductive health and childbirth, Conservative Treatment, Low Birth Weight and Health of the Newborn, Pediatrics, law.invention, Randomized controlled trial, law, newborn, Ductus arteriosus, Infant Mortality, Medicine, retinopathy of prematurity, Single-Blind Method, Continuous positive airway pressure, Prospective Studies, Ductus Arteriosus, Patent, Lung, Pediatric, Continuous Positive Airway Pressure, Gestational age, Retinopathy of prematurity, Hematology, premature birth, medicine.anatomical_structure, Treatment Outcome, Premature birth, Anesthesia, Infant, Extremely Premature, Necrotizing enterocolitis, Patent, Female, congenital, hereditary, and neonatal diseases and abnormalities, Clinical Trials and Supportive Activities, Gestational Age, Extremely Premature, TO LEave it alone or Respond And Treat Early) Trial Investigators [PDA-TOLERATE (PDA], Paediatrics and Reproductive Medicine, Clinical Research, Preterm, bronchopulmonary dysplasia, Humans, Cyclooxygenase Inhibitors, Acetaminophen, necrotizing enterocolitis, business.industry, Infant, Newborn, nutritional and metabolic diseases, Infant, Ductus Arteriosus, Human Movement and Sports Sciences, Perinatal Period - Conditions Originating in Perinatal Period, medicine.disease, Good Health and Well Being, Bronchopulmonary dysplasia, Pediatrics, Perinatology and Child Health, business, Digestive Diseases
Abstract

ObjectiveTo compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given.Study designA total of 202 neonates of

Published
2019

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