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1. Association between Term Equivalent Brain Magnetic Resonance Imaging and 2-Year Outcomes in Extremely Preterm Infants: A Report from the Preterm Erythropoietin Neuroprotection Trial Cohort

Author

Dennis E. Mayock, Semsa Gogcu, Mihai Puia-Dumitrescu, Dennis W.W. Shaw, Jason N. Wright, Bryan A. Comstock, Patrick J. Heagerty, Sandra E. Juul, Rajan Wadhawan, 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 Khan, Michael Weiss, Maureen M. Gilmore, Robin K. Ohls, Jean Lowe, Nishant Srinivasan, Jorge E. Perez, Victor McKay, Billy Thomas, Nahed Elhassan, Sarah Mulkey, Vivek K. Vijayamadhavan, Neil Mulrooney, Bradley Yoder, Jordan S. Kase, Jennifer Check, Erin Osterholm, Thomas George, Michael Georgieff, Camilia R. Martin, Deirdre O'Reilly, Raye-Ann deRegnier, Nicolas Porta, Catalina Bazacliu, Frances Northington, Raul Chavez Valdez, Patel Saurabhkumar, Magaly Diaz-Barbosa, Todd Richards, John B. Feltner, Isabella Esposito, Stephanie Hauge, Samantha Nikirk, Amy Silvia, Bailey Clopp, Debbie Ott, Ariana Franco Mora, Pamela Hedrick, Vicki Flynn, Andrea Wyatt, 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 Cole, 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, Neha Talele, Evelyn Obregon, Tiglath Ziyeh, Molly Clarke, Rachel E. Wegner, Palak Patel, Molly Schau, Annamarie Russow, Kelly Curry, Lisa Barnhart, Charlamaine Parkinson, Sandra Beauman, Mary Hanson, Elizabeth Kuan, Conra Backstrom Lacy, Edshelee M. Galvis, Susana Bombino, Denise Martinez, Suzi Bell, Corrie Long, Christopher Nefcy, Mark A. Konodi, Phuong T. Vu, Adam Hartman, T. Michael O'Shea, Roberta Ballard, Mike O'Shea, Karl Kuban, and John Widness

Subjects
Male, Pediatrics, medicine.medical_specialty, Placebo, Bayley Scales of Infant Development, Article, Double-Blind Method, Medicine, Humans, Erythropoietin, Periventricular leukomalacia, business.industry, Infant, Newborn, Gestational age, Brain, Infant, Retinopathy of prematurity, medicine.disease, Neuroprotection, Intraventricular hemorrhage, Bronchopulmonary dysplasia, Neurodevelopmental Disorders, Child, Preschool, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Cohort, Female, business
Abstract

Objectives To compare the term equivalent brain magnetic resonance imaging (MRI) findings between erythropoietin (Epo) treated and placebo control groups in infants 240/7-276/7 weeks of gestational age and to assess the associations between MRI findings and neurodevelopmental outcomes at 2 years corrected age. Study design The association between brain abnormality scores and Bayley Scales of Infant Development, Third Edition at 2 years corrected age was explored in a subset of infants enrolled in the Preterm Erythropoietin Neuroprotection Trial. Potential risk factors for neurodevelopmental outcomes such as treatment assignment, recruitment site, gestational age, inpatient complications, and treatments were examined using generalized estimating equation models. Results One hundred ten infants were assigned to Epo and 110 to placebo groups. 27% of MRI scans were rated as normal, and 60%, 10%, and 2% were rated as having mild, moderate, or severe abnormality. Brain abnormality scores did not significantly differ between the treatment groups. Factors that increased the risk of higher brain injury scores included intubation; bronchopulmonary dysplasia; retinopathy of prematurity; opioid, benzodiazepine, or antibiotic treatment >7 days; and periventricular leukomalacia or severe intraventricular hemorrhage diagnosed on cranial ultrasound. Increased global brain abnormality and white matter injury scores at term equivalent were associated with reductions in cognitive, motor, and language abilities at 2 years of corrected age. Conclusions Evidence of brain injury on brain MRIs obtained at term equivalent correlated with adverse neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development, Third Edition at 2 years corrected age. Early Epo treatment had no effect on the MRI brain injury scores compared with the placebo group.

Published
2021

2. 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

3. Maternal Black Race and Persistent Wheezing Illness in Former Extremely Low Gestational Age Newborns: Secondary Analysis of a Randomized Trial

Author

Katherine C. Wai, Anna M. Hibbs, Martina A. Steurer, Dennis M. Black, Jeanette M. Asselin, Eric C. Eichenwald, Philip L. Ballard, Roberta A. Ballard, Roberta L. Keller, Suzanne Hamilton Strong, Jill Immamura-Ching, Margaret Orfanos-Villalobos, Cassandra Williams, David J. Durand, Jeffrey D. Merrill, Dolia Horton, Loretta Pacello, April Willard, William E. Truog, Cheryl Gauldin, Anne Holmes, Patrice Johnson, Kerrie Meinert, Anne Marie Reynolds, Janine Lucie, Patrick Conway, Michael Sacilowski, Michael Leadersdorff, Pam Orbank, Karen Wynn, Robin H. Steinhorn, Maria deUngria, Janine Yasmin Khan, Karin Hamann, Molly Schau, Brad Hopkins, James Jenson, Carmen Garcia, Aruna Parekh, Jila Shariff, Rose McGovern, Jeff Adelman, Adrienne Combs, Mary Tjersland, Dennis E. Mayock, Elizabeth Howland, Susan Walker, Jim Longoria, Holly Meo, Amir Khan, Georgia McDavid, Katrina Burson, Richard Hinojosa, Christopher Johnson, Karen Martin, Sarah Martin, Shawna Rogers, Sharon Wright, Mark L. Hudak, Kimberly Barnette, Amanda Kellum, Michelle Burcke, Christie Hayes, Stephanie Chadwick, Danielle Howard, Carla Kennedy, Renee Prince, Jennifer Helderman, T. Michael O'Shea, Beatrice Stefanescu, Kelly Warden, Patty Brown, Jennifer Griffin, Laura Conley, Catherine M. Bendel, Michael Georgieff, Bridget Davern, Marla Mills, Sharon Ritter, Carol Wagner, Rita M. Ryan, Deanna Fanning, Jimmy Roberson, Mark C. Mammel, Andrea Lampland, Pat Meyers, Angela Brey, Ellen M. Bendel-Stenzel, Neil Mulrooney, Cathy Worwa, Pam Dixon, Gerald Ebert, Cathy Hejl, Molly Maxwell, Kristin McCullough, Ramasubbareddy Dhanireddy, Mohammed T. El Abiad, Ajay Talati, Sheila Dempsey, Kathy Gammage, Gayle Gower, Kathy James, Pam LeNoue, Victor J. McKay, Suzi Bell, Dawn Bruton, Michelle Beaulieu, Richard Williams, Rajan Wadhawan, Robin Barron-Nelson, Shane Taylor, Sherry E. Courtney, Carol Sikes, Gary Lowe, Betty Proffitt, Elizabeth E. Rogers, Cheryl Chapin, Hart Horneman, Susan Kelley, Karin Knowles, Nancy Newton, Eric Vittinghoff, Jean Hietpas, Laurie Denton, Lisa Palermo, and Lucy Wu

Subjects
Male, Pediatrics, medicine.medical_specialty, Birth weight, Mothers, Infant, Premature, Diseases, Breast milk, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Risk Factors, law, 030225 pediatrics, Wheeze, medicine, Humans, 030212 general & internal medicine, Respiratory Sounds, Asthma, business.industry, Infant, Newborn, Infant, Gestational age, medicine.disease, Respiration, Artificial, Black or African American, Bronchopulmonary dysplasia, Child, Preschool, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Gestation, Female, medicine.symptom, business
Abstract

Objective To evaluate the relationship between maternal self-reported race/ethnicity and persistent wheezing illness in former high-risk, extremely low gestational age newborns, and to quantify the contribution of socioeconomic, environmental, and biological factors on this relationship. Study design We assessed persistent wheezing illness determined at 18-24 months corrected (for prematurity) age in survivors of a randomized trial. Parents/caregivers were surveyed for wheeze and inhaled asthma medication use quarterly to 12 months, and at 18 and 24 months. We used multivariable analysis to evaluate the relationship of maternal race to persistent wheezing illness, and identified mediators for this relationship via formal mediation analysis. Results Of 420 infants (25.2 ± 1.2 weeks of gestation and 714 ± 166 g at birth, 57% male, 34% maternal black race), 189 (45%) had persistent wheezing illness. After adjustment for gestational age, birth weight, and sex, infants of black mothers had increased odds of persistent wheeze compared with infants of nonblack mothers (OR = 2.9, 95% CI 1.9, 4.5). Only bronchopulmonary dysplasia, breast milk diet, and public insurance status were identified as mediators. In this model, the direct effect of race accounted for 69% of the relationship between maternal race and persistent wheeze, whereas breast milk diet, public insurance status, and bronchopulmonary dysplasia accounted for 8%, 12%, and 10%, respectively. Conclusions Among former high-risk extremely low gestational age newborns, infants of black mothers have increased odds of developing persistent wheeze. A substantial proportion of this effect is directly accounted for by race, which may reflect unmeasured environmental influences, and acquired and innate biological differences. Trial registration ClinicalTrials.gov : NCT01022580 .

Published
2018
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4. Iron Deficiency Alters Auditory Recognition Memory in Newborn Infants of Diabetic Mothers

Author

Raye Ann deRegnier, Ashajyothi M. Siddappa, Cathy Worwa, Michael K. Georgieff, Charles A. Nelson, and Sandi S. Wewerka

Subjects
Pediatrics, medicine.medical_specialty, Cord, Pregnancy in Diabetics, Mothers, Hippocampus, Audiology, Memory, Pregnancy, medicine, Humans, Recognition memory, Psychomotor learning, biology, business.industry, Infant, Newborn, Brain, Infant, Iron Deficiencies, Iron deficiency, Fetal Blood, medicine.disease, Ferritin, Iron-deficiency anemia, Ferritins, Pediatrics, Perinatology and Child Health, Auditory Perception, Evoked Potentials, Auditory, Voice, biology.protein, Female, business
Abstract

Infants of diabetic mothers (IDMs) are at risk for perinatal brain iron deficiency that may target the developing hippocampus. The objective of this study was to evaluate hippocampally based recognition memory and infant development in IDMs with suspected brain iron deficiency (BID; cord ferritin/=34 microg/L) compared with IDMs with sufficient brain iron stores (BIS; cord ferritin34 microg/L) using event-related potentials (ERPs). ERPs assessed neonatal auditory cortical responses to sounds and auditory recognition memory in response to the mother's voice compared with a stranger's voice. Thirty-two newborn IDMs had cord serum ferritin concentrations and provided neonatal ERP data (n = 23) and/or blinded 1 y developmental assessments (n = 28). Auditory cortical responses to speech and nonspeech sounds were similar in the BID and BIS groups. In the maternal voice recognition paradigm, peak latencies were shorter in the BID group than in the BIS group. Infants in the BIS group displayed a significant negative slow wave for the strangers' voices compared with the mothers' voices, whereas the BID group did not. Higher cord ferritin concentrations were correlated with larger negative slow waves at the right temporal (T4) electrode site. At 1 y of age, motor development was slower in the BID group than in the BIS group. IDMs suspected to have BID demonstrated impaired neonatal auditory recognition memory and lower psychomotor developmental scores at 1 y of age than IDMs with BIS. These impairments map onto areas of the developing brain known to be vulnerable to iron deficiency.

Published
2004
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