Hyperbilirubinemia, Neonatal

BARGERSVILLE, Ind., Sept. 16, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Paul Delbert Winchester, MD is acknowledged as a Top Pinnacle Neonatologist for his contributions in Neonatology. Dr. Winchester, an esteemed neonatologist with a career spanning over four decades, has made significant contributions to the field of neonatology and pediatric care. His dedication to the well-being of infants and children has earned him recognition as a leading expert in the field. Continue Reading Paul Winchester Currently serving as the Professor of Neonatology at the Riley Hospital for Children at Indiana University Health in Indianapolis, and attending Neonatologist at St. Francis Hospital, Indiana, Dr. Winchester has been at the forefront of neonatal acute care since 1981. Dr. Winchester is renowned for his innovative and comprehensive approach to clinical care. His emphasis on understanding patients' medical histories and a strong focus on preventive measures has set him apart as a practitioner who goes above and beyond to ensure the well-being of the young patients under his care. His educational journey began with a Bachelor of Arts in experimental psychology from Stanford University in 1970. He continued to excel academically, earning a Master of Arts from the University of Michigan in 1972 and a Doctor of Medicine Internship and Residency in pediatrics in 1979, and Fellowship in Neonatology 1981 at the University of Colorado Medical Center in Denver. The board-certified physician is a Fellow of the American Academy of Pediatrics and is currently affiliated with Indiana University School of Medicine as a Clinical Professor and Riley Hospital, Eskenazi Hospital, Francis Hospital, Indianapolis, as medical staff. The doctor is board-certified in pediatrics and neonatal and perinatal medicine; is a PALS provider; and is an NRP Instructor/provider. Throughout his career, Dr. Winchester has achieved several remarkable milestones. Notably, he holds the distinction of being the first neonatologist to practice outside of Denver, Colorado. He developed the first Level III NICU outside of Denver in Colorado in 1981, which tripled survival rates in very low birth-weight babies in 6 months; developed Neonatal Nurse Practitioner Program with Marsha London, RN at Beth-El School of Nursing, Colorado Springs; was a member of the First Neonatal Transport Team for Fort Carson Army Mast Helicopters, as well as Mayo Fixed Wing medical transports; Neonatal Fellowship (Beth Murdoch) program with Bill Haye, MD CUMC; Resuscitation and intubation labs for Southern Colorado Family Practice Program in Pueblo, Colorado. Dr. Winchester has made several significant contributions to the field of neonatology making him a world-renowned physician. Dr. Winchester developed the first High Frequency Ventilator in Colorado with designs incorporated into commercial HFJV now in use; introduced High Frequency Ventilation to Colorado, Kansas and New Hampshire; was awarded a March of Dimes grant to begin the first Prematurity Prevention Program in Colorado in 1982 along with Maria Carlos and Robert Creasy MD; had the first reported use of prenatal steroids in preterm labor mothers <28 weeks gestation, which doubled survival rates and cut severe IVH rates in half; was the first to use post-natal steroids to treat BPD in Colorado which was adopted by Gordon Avery Washington Children's Hospital; helped develop ultrasound as a diagnostic test for neonatal intraventricular hemorrhage along with Carol Rumack, MD; developed clinical care flow sheet which is under the Baby's Benefit copyright; and discovered that preterm birth is heritable. Dr. Winchester adds that he developed Paul's three rules: 1) if you have it you've always had it 2) if you have it, your family has it 3) if you have it you "marry" it, (choices of place to live, place to work, profession, likes and dislikes, are all informed by your genome). Among his great accomplishments, Dr. Winchester, along with colleague Rodney Levine NIH, is credited with making the groundbreaking discovery in Kansas City that a phenol-based germicide used to clean bassinets was a cause for newborn jaundice. He also organized mentorship programs for Blue Valley High School and Shawnee Mission School District and entered into a congressional agreement with manufacturers (Merk) to not market to newborn care facilities. In New Hampshire, he discovered that prenatal steroids influence the post-menstrual day of discharge from the NICU by accelerating physiological maturity with Robert Darnell Dartmouth Medical Center. During his time in Indiana the doctor discovered that the two leading causes of Infant Death (birth defects and preterm birth) both peak in the months of peak pesticides in US surface waters and went on to discover that 93-99% of pregnant Hoosier mothers are exposed to the weed killer glyphosate (GLY) (aka Round Up), and that higher levels of glyphosate shorten pregnancies, which leads to premature birth in some and reduces fetal growth. After Winchester and colleagues finding that a majority of US Women are exposed to glyphosate, the CDC and other investigators confirmed the findings and added additional adverse effects to the list including the additional impact of AMPA (the main metabolite of glyphosate) , masculinization of female genitals and predisposition to fatty liver disease. With collaborator Mike Skinner from WSU, Dr. Winchester found that GLY induces epigenetic changes in exposed offspring which translated into "heritable" diseases such as obesity, perinatal mortality, and multiple disorders and has contributed numerous abstracts and presentations for more than 20 years to the annual Academic Society for Pediatrics, formerly SPR. He has a plethora of grants that have made much of his research possible. Dr. Winchester's work history includes serving as the Director of Neonatology at Memorial Hospital in Colorado Springs from 1981 to 1990 and a faculty role at the University of Colorado, where he shared his expertise by teaching clinical pediatric coursework from 1985 to 1986. He has more than 40 years practicing in Neonatology, founding two level III NICUS at Memorial Hospital in Colorado Springs, Colorado and Overland Park Regional Medical Center in Kansas where he directed four NICUS including one at Elliot Hospital, NH and St. Francis Hospital, IN. He is an esteemed member of numerous professional organizations, including the American Academy of Pediatrics where he is distinguished as a Fellow; District VIII Perinatal Medical Society; Subspecialty Board Neonatology at the American Academy of Pediatrics; and was a clinical instructor at the Department of Pediatrics at the University of Colorado and the University of Kansas (KUMC). Dr. Winchester has also received numerous distinctions and awards during his illustrious career including: Stanford Management Intern (SNIP) of the Year Award in 1968; graduated with honors from Stanford University in 1970; is a recipient of the Franklin P. Gengenbach Award for Best Pediatric Student in 1974-1975; March of Dimes "Make a Difference" Award in Greater Kansas City in 1991; Red Shoes Award at Riley Hospital in 2005; Indiana Public Health Association's Tony and Mary Hulman Achievement Award for Health Science Research in November 2013. The Top Doc Award in the Indianapolis Monthly Magazine in 2014, 2016-2021; Castle Connolly Top Doctor Award in 2016. Dr. Winchester is a highly sought-after professional and expert in the field and has served in many other capacities during his career including being a member of the NAS Multi-disciplinary Task Force at St. Francis Medical Center; founded and supported the Annual Perinatal Conference "Growth and Challenge" in Colorado Springs, Colorado; and supported as Clinical Advisor Research Fellowship by Amira Bastawisi, MD-Risk Factors for Premature Birth in Colorado Research tool developed by P.S. Winchester and Elizabeth Kyre. He has been an invited lecturer at numerous conferences including The Iowa Governor's Conference on Public Health where he was the keynote speaker and the Indianapolis Healthy Babies Consortium Meeting as a featured speaker. As a renowned researcher, with presentations from 2001-2024 at annual Academic Pediatric Society Meetings. Dr. Winchester has countless IRB's adding to the body of work supporting neonatal care and other medically relevant studies. He is both a mentor to numerous trainees, students and professionals and at the forefront of Pediatric and Neonatology research and development, saving countless lives and improving the odds for hundreds of infants and mothers. The doctor is a consummate supporter of the community including Greenwood High School Honors Biology Research Program with Becky Kehler (now in Sarasota County Schools, Fla). He worked with the Marion County Prosecutor's Office as a consultant and has supported Johnson County 4-H Fair as a Grand Champion in Artistic Painting. Looking ahead, Dr. Winchester envisions a future filled with continued growth and success in the field of neonatology and pediatrics. He is pursuing the next steps in protecting pregnant women from unwanted chemicals now contaminating them while pregnant. He explained, "our discovery of glyphosate in most pregnant women is just one of a litany of chemicals now found in every life form on the planet. The capacity of these chemicals to alter the DNA of our offspring, inducing diseases across generations, is the next big challenge which we heretofore weren't aware of. Infertility is the worst of these chemicals' effects since it will lead to the inability of the human race to reproduce naturally if not altered." The doctor added that, "the privilege of treating sick newborns comes with the responsibility to find the origin of their diseases: preterm birth, birth defects, fetal growth restriction and their impact of cognitive and physical development of our children. Most chronic diseases today have their origins in ancestral environmental contaminants through epigenetic fetal changes. We are perfecting the means of keeping preterm babies alive, but they should never have to be born premature or sick in the first place. Our next big step is to provide the pharmacological, proteomic, probiotic, nutritional and medical, and psychological means to prepare women and their spouses for an optimal state of health before they become pregnant. This will include chemical surveillance, epigenetic and genetic surveillance and counseling, and may, one day, include modifiers for both genetic and epigenetic risk variants." Dr. Winchester's current primary research focuses on the role that prenatal herbicides impact the pregnancy, fetal development and long-term neuro-psychological development of exposed offspring including the potential role these contaminants have on childhood conditions such as autism spectrum disorder and attention, anxiety, depression disorders. His other research interests also include Physiological Maturation of the Neonate and Readiness for Discharge; III Neonatal Data Systems, Computerization of OB/Neonatal Data Base; and Sleep Study Program at Overland Park Regional Medical Center. Aside from Dr. Winchester's incredible career and influence in the medical field, he is a former athlete excelling in many sports including football where he was an All-State Athlete at Bozeman Senior High School and Division Champion in wrestling for Pacific Coast Small Colleges in 1967 at Lewis and Clark. He grew up on Winchester Angus Cattle Ranch in Bozeman, Montana. The doctor has more than 4 decades of extraordinary experiences, collaborating with national and international professionals. He has lived in Ankara, Turkey, studied in Tours, France and Edinburgh, Scotland, and speaks French, Spanish, and some German. While Dr. Winchester's professional achievements are indeed noteworthy, he considers his most gratifying accomplishment to be the extraordinary success of his four children, 3 grandchildren and counting, and wife, Deb, who remains his most important partner in life. Reflecting on his journey, Dr. Winchester acknowledges the influence of his parents, Burl Winchester and Carolyn Winchester; Mark Winchester MD (brother); Band director Percy Bronson; 4th grade teacher Mrs. Knoll; Wrestling and Football Coach Tom Le Prouse; Bozeman Senior High School; Del Weber, former President of California Teachers Association; Gordon Bower PhD Professor, Stanford University; Cy Gilbert director, Plans Programs American Airlines; Robert Bjork PhD Professor UCLA; Patrick O'Meara MD and Sharon Langendorfer MD at the University of Colorado Medical Center; Thomas Bouchard, University of Minnesota (Minnesota Twin Study); Ernie Beal MD Elliot Hospital; William Edwards MD, Dartmouth Medical School; James Lemons MD, former Chief Division of Neonatology Riley Hospital for Children and Indiana University School of Medicine, and early teachers who encouraged his pursuits. He also pays tribute to Dr. James A. Lemons, MD, the Chair of the Neonatal Department at the Indiana University School of Medicine, as a significant mentor who shaped his career along with his wife, Deb Winchester. Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Nipocalimab delayed or prevented severe fetal anemia and 54 percent of study participants in the Phase 2 UNITY study achieved a live birth at or after 32 weeks without the need for intrauterine transfusion (IUT) The AZALEA Phase 3 clinical study is currently enrolling patients: Nipocalimab is the only therapy in clinical development for use in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN) SPRING HOUSE, Pa., Aug. 7, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the results from the Phase 2 open-label UNITY study of nipocalimab for the treatment of alloimmunizeda pregnant individuals at risk of early onset severe (EOS) HDFN have been published in The New England Journal of Medicine (NEJM). The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT.1 Nipocalimab is currently the only therapy reported to be in clinical development for HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the developing fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.2 These results showed that nipocalimab delayed or prevented severe fetal anemia requiring treatment prenatally and reduced the need for IUTs in pregnancies at high risk for recurrent EOS HDFN.1 "The Phase 2 data published in the NEJM are encouraging, as the results support the potential of nipocalimab in the treatment of pregnant individuals with a history of severe HDFN, helping to establish a path forward for further development in this disease in a larger scale Phase 3 study," said Kenneth J. Moise Jr., M.D., Professor, Department of Women's Health and Co-Director, Comprehensive Fetal Care Center at Dell Medical School of the University of Texas at Austin and lead study investigatorb. "For many patients, severe HDFN has a poor prognosis, and the current standard of care carries with it a high treatment burden, such as repeated IUTs and additional in-utero procedures that require access to specialty care and carry a risk to the life of the fetus. If approved, nipocalimab would be the first non-surgical treatment for pregnancies at high risk of HDFN."3 The multicenter, open-label, single-arm Phase 2 UNITY study assessed intravenous nipocalimab from 14-35 weeks in pregnancies at high risk for recurrent EOS HDFN.1 The primary endpoint of the study is live birth at ≥32 weeks GA without IUT. Study results showed the primary endpoint was achieved in 54 percent (7/13) of pregnancies versus the 10 percent historical benchmark (95 percent CI, 25.1-80.8; P<0.001).1 The NEJM manuscript includes new data that compares the outcomes of qualifying pregnanciesc and on-study (UNITY) pregnancies.1 The comparison revealed that study pregnancies had a higher proportion of live births (92 percent versus 38 percent), fewer participants requiring IUTs (85 percent versus 46 percent), a later median GA at first IUT (27 and 1/7 weeks versus 20 and 4/7 weeks) and a later median GA at delivery (36 4/7 weeks versus 23 and 6/7 weeks).1 Additionally, among pregnant individuals who joined the study, seven had a fetus that developed hydrops in their most recent qualifying pregnancy, whereas no incidences of hydrops occurred in the study pregnancies.1 In the UNITY study, the most frequently reported adverse events were consistent with those common in pregnancy and HDFN.1 Serious side effects were consistent with HDFN or other pregnancy-related conditions including subchorionic hematoma and premature separation of the placenta.1 Infections and illnesses in infants of mothers exposed to nipocalimab were consistent with those typically observed in the neonatal and infancy period.1 No maternal or neonatal/infant deaths occurred in the study.1 One pregnancy resulted in fetal demise related to a complication of an IUT.1 The UNITY study demonstrated positive efficacy and safety results which supports a favorable benefit risk profile for nipocalimab.1 Thus, the UNITY study results support further clinical development of nipocalimab for the treatment of severe HDFN.1 The AZALEA Phase 3 pivotal study is currently enrolling pregnant individuals at risk for severe HDFN who have a history of severe HDFN in a prior pregnancy(ies) to further assess the efficacy and safety of nipocalimab.4 In addition, Johnson & Johnson is conducting a Phase 3 study of nipocalimab in fetal and neonatal alloimmune thrombocytopenia (FNAIT), which has been considered to be the platelet counterpart of HDFN.5 FNAIT is an alloimmune disorder of pregnancy that results when the pregnant person's immune system attacks fetal or newborn platelets, resulting in thrombocytopenia and risk of bleeding, which can be life-threatening.6 "We are committed to developing non-surgical options that are effective and have a proven safety profile for the treatment of alloantibody-driven maternal-fetal diseases," said Katie Abouzahr, M.D., Vice President, Autoantibody Diseases and Maternal-Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. "The data published in the NEJM underscore the potential of nipocalimab to address the high unmet medical need in severe HDFN, a serious, life-threatening and rare condition in which no other therapies in clinical development exist." Editor's Notes: a. Alloimmunized: immune response to foreign antigens upon exposure to genetically different cells or tissues b. Dr. Kenneth Moise is a paid consultant for Janssen. He has not been compensated for any media work. c. Most recent qualifying pregnancy: previous HDFN pregnancy that made the participant eligible for the UNITY Phase 2 study ABOUT THE UNITY STUDY UNITY (NCT03842189) is a global, multicenter, non-blinded Phase 2 clinical study designed to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of nipocalimab for the treatment of pregnant individuals at high risk for early-onset severe (EOS)-HDFN.7 The study enrolled RhD (D) or Kell (K) alloimmunized pregnant individuals with singleton pregnancies at high risk for EOS-HDFN due to an obstetric history of severe fetal anemia, fetal hydrops, or a stillbirth at ≤24 weeks GA.1 The primary endpoint was live birth at or after GA of 32 weeks, without a need for an intrauterine transfusion (IUT) throughout the entire pregnancy.1 Safety was monitored for 24 weeks post-delivery for the 13 maternal individuals enrolled, and up to 96 weeks post-birth for infants. Participants received once-weekly intravenous infusions.1 The study met the primary endpoint, with 54 percent of pregnant participants who received nipocalimab achieving a live birth at or after 32 weeks GA, without the need for an IUT throughout their entire pregnancy.1 ABOUT HDFN Hemolytic disease of the fetus and newborn (HDFN) is a rare disease (and in its severe form, ultra rare) that arises in pregnancies with maternal-fetal incompatibility in certain red blood cell types.8 Alloantibodies produced by the maternal immune system against fetal red blood cells cross the placenta during pregnancy and attack fetal red blood cells causing fetal anemia or persist after birth in the neonate to cause neonatal hyperbilirubinemia and anemia.2 The symptoms of HDFN can range from mild jaundice, to neurotoxic hyperbilirubinemia in the newborn, to life-threatening fetal anemia requiring invasive intervention.9 The potential for in utero onset at an increasingly earlier GA with increasing risk of severe outcomes may occur with each incompatible pregnancy due to pregnancy-related alloimmunization.10 Currently no non-surgical interventions are approved for pregnancies at high risk for severe HDFN.3 Pregnancies affected by severe HDFN may necessitate repeated intrauterine transfusions (IUTs), which are invasive, technically complex surgical procedures performed by specialists at specialized medical centers, and these procedures are associated with an increased rate of fetal mortality and premature birth.11,12, 13 The most difficult to treat cases of HDFN are early onset severe HDFN (EOS-HDFN) that develops at ≤24 weeks gestational age (GA) and results in significant fetal/neonatal morbidity and mortality. According to the American Journal of Obstetrics and Gynecology, in the U.S., it is estimated that up to 80 of every 100,000 pregnancies are affected by HDFN each year.14 ABOUT NIPOCALIMAB Nipocalimab is an investigational monoclonal antibody, purposefully designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, while preserving immune function without causing broad immunosuppression. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal-Fetal diseases mediated by maternal alloantibodies and Prevalent Rheumatology.15,16,17,18,19,20,21,22,23 Blockade of IgG binding to FcRn in the placenta is also believed to prevent transplacental transfer of maternal alloantibodies to the fetus.24,25 The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including: Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy CIDP in October 2021 and FNAIT in December 2023 Breakthrough Therapy designation for HDFN by the FDA in February 2024 Orphan medicinal product designation for HDFN by the EMA in October 2019 ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 Kenneth J. Moise Jr., et al. Nipocalimab in Early-onset Severe Hemolytic Disease of the Fetus & Newborn. N Engl J Med. 2024; DOI: 10.1056/NEJMoa2314466. 2 National Library of Medicine. Hemolytic Diseases of the Newborn. StatPearls Publishing. 2023 Jan. Available at: . Last accessed: August 2024. 3 DeMoss, P., Asfour, M. and Hersey, K. Anti-K1 (Kell) antibody expressed in maternal breastmilk: A case report of a neonate with multiple intrauterine transfusions and postnatal exposure to Kell antibody in maternal breastmilk', Case reports in pediatrics. 2017. Doi:10.1155/2017/6927813. Last accessed: August 2024. 4 Clinicaltrials.gov. A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Pregnant Women at High Risk for Early Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN). Last accessed: August 2024. . 5 Orphanet. Fetal and Neonatal Alloimmune Thrombocytopenia. . Last accessed: August 2024. 6 NORD. Fetal and Neonatal Alloimmune Thrombocytopenia. Published online July 2022. . Last accessed August 2024. 7 ClinicalTrials.gov Identifier: NCT03842189. Available at: . Last accessed: August 2024. 8 Hemolytic disease of the newborn. Medline Plus. Last accessed: August 2024. 9 Ree IMC, Smits-Wintjens VEHJ, van der Bom JG, et al. Neonatal management and outcome in alloimmune hemolytic disease, Expert Review of Hematology, 10:7, 607-616, doi: 10.1080/17474086.2017.1331124. Last accessed: August 2024. 10 Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. Doi: 10.1007/s00404-007-0446-x. Last accessed: August 2024. 11 Texas Children's Hospital. Intrauterine Transfusion. Available at: . Last accessed: August 2024. 12 de Winter DP, Kaminski A, et al. Hemolytic disease of the fetus and newborn: systematic literature review of the antenatal landscape. BMC Pregnancy and Childbirth. 2023;23(12). Doi: . Last accessed: August 2024. 13 Lindenburg IT, van Kamp IL, van Zwet EW, Middeldorp JM, Klumper FJ, Oepkes D. Increased perinatal loss after intrauterine transfusion for alloimmune anaemia before 20 weeks of gestation. BJOG. 2013 Jun;120(7):847-52. doi: 10.1111/1471-0528.12063. 14 Delaney M, Matthews DC. Hemolytic disease of the fetus and newborn: managing the mother, fetus, and newborn. Hematology Am Soc Hematol Educ Program. (2015) 2015(1):146-151. doi: . Last accessed: August 2024. 15 ClinicalTrials.gov Identifier: NCT04951622. Available at: . Last accessed: August 2024. 16 ClinicalTrials.gov. NCT03842189. Available at: . Last accessed: August 2024. 17 ClinicalTrials.gov Identifier: NCT05327114. Available at: . Last accessed: August 2024. 18 ClinicalTrials.gov Identifier: NCT04119050. Available at: . Last accessed: August 2024. 19 ClinicalTrials.gov Identifier: NCT05379634. Available at: . Last accessed: August 2024. 20 ClinicalTrials.gov Identifier: NCT05912517. Available at: . Last accessed: August 2024 21 ClinicalTrials.gov Identifier: NCT06028438. Available at: . Last accessed: August 2024. 22 ClinicalTrials.gov Identifier: NCT04968912. Available at: . Last accessed: August 2024. 23 ClinicalTrials.gov Identifier: NCT04882878. Available at: . Last accessed: August 2024. 24 Lobato G, Soncini CS. Relationship between obstetric history and Rh(D) alloimmunization severity. Arch Gynecol Obstet. 2008 Mar;277(3):245-8. DOI: 10.1007/s00404-007-0446-x. Last accessed: June 2024. 25 Roy S, Nanovskaya T, Patrikeeva S, et al. M281, an anti-FcRn antibody, inhibits IgG transfer in a human ex vivo placental perfusion model. Am J Obstet Gynecol. 2019;220(5):498 e491-498 e499. SOURCE Johnson & Johnson

BARGERSVILLE, Ind., May 13, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Paul Delbert Winchester, MD is acknowledged as a Top Pinnacle Neonatologist for his contributions in Neonatology. Dr. Winchester, an esteemed neonatologist with a career spanning over four decades, has made significant contributions to the field of neonatology and pediatric care. His dedication to the well-being of infants and children has earned him recognition as a leading expert in the field. Continue Reading Paul Delbert Winchester Currently serving as the Professor of Neonatology at the Riley Hospital for Children at Indiana University Health in Indianapolis, and attending Neonatologist at St. Francis Hospital, Indiana, Dr. Winchester has been at the forefront of neonatal acute care since 1981. Dr. Winchester is renowned for his innovative and comprehensive approach to clinical care. His emphasis on understanding patients' medical histories and a strong focus on preventive measures has set him apart as a practitioner who goes above and beyond to ensure the well-being of the young patients under his care. His educational journey began with a Bachelor of Arts in experimental psychology from Stanford University in 1970. He continued to excel academically, earning a Master of Arts from the University of Michigan in 1972 and a Doctor of Medicine Internship and Residency in pediatrics in 1979, and Fellowship in Neonatology 1981 at the University of Colorado Medical Center in Denver. The board-certified physician is a Fellow of the American Academy of Pediatrics and is currently affiliated with Indiana University School of Medicine as a Clinical Professor and Riley Hospital, Eskenazi Hospital, Francis Hospital, Indianapolis, as medical staff. The doctor is board-certified in pediatrics and neonatal and perinatal medicine; is a PALS provider; and is an NRP Instructor/provider. Throughout his career, Dr. Winchester has achieved several remarkable milestones. Notably, he holds the distinction of being the first neonatologist to practice outside of Denver, Colorado. He developed the first Level III NICU outside of Denver in Colorado in 1981, which tripled survival rates in very low birth-weight babies in 6 months; developed Neonatal Nurse Practitioner Program with Marsha London, RN at Beth-El School of Nursing, Colorado Springs; was a member of the First Neonatal Transport Team for Fort Carson Army Mast Helicopters, as well as Mayo Fixed Wing medical transports; Neonatal Fellowship (Beth Murdoch) program with Bill Haye, MD CUMC; Resuscitation and intubation labs for Southern Colorado Family Practice Program in Pueblo, Colorado. Dr. Winchester has made several significant contributions to the field of neonatology making him a world-renowned physician. Dr. Winchester developed the first High Frequency Ventilator in Colorado with designs incorporated into commercial HFJV now in use; introduced High Frequency Ventilation to Colorado, Kansas and New Hampshire; was awarded a March of Dimes grant to begin the first Prematurity Prevention Program in Colorado in 1982 along with Maria Carlos and Robert Creasy MD; had the first reported use of prenatal steroids in preterm labor mothers <28 weeks gestation, which doubled survival rates and cut severe IVH rates in half; was the first to use post-natal steroids to treat BPD in Colorado which was adopted by Gordon Avery Washington Children's Hospital; helped develop ultrasound as a diagnostic test for neonatal intraventricular hemorrhage along with Carol Rumack, MD; developed clinical care flow sheet which is under the Baby's Benefit copyright; and discovered that preterm birth is heritable. Dr. Winchester adds that he developed Paul's three rules: 1) if you have it you've always had it 2) if you have it, your family has it 3) if you have it you "marry" it, (choices of place to live, place to work, profession, likes and dislikes, are all informed by your genome). Among his great accomplishments, Dr. Winchester, along with colleague Rodney Levine NIH, is credited with making the groundbreaking discovery in Kansas City that a phenol-based germicide used to clean bassinets was a cause for newborn jaundice. He also organized mentorship programs for Blue Valley High School and Shawnee Mission School District and entered into a congressional agreement with manufacturers (Merk) to not market to newborn care facilities. In New Hampshire, he discovered that prenatal steroids influence the post-menstrual day of discharge from the NICU by accelerating physiological maturity with Robert Darnell Dartmouth Medical Center. During his time in Indiana the doctor discovered that the two leading causes of Infant Death (birth defects and preterm birth) both peak in the months of peak pesticides in US surface waters and went on to discover that 93-99% of pregnant Hoosier mothers are exposed to the weed killer glyphosate (GLY) (aka Round Up), and that higher levels of glyphosate shorten pregnancies, which leads to premature birth in some and reduces fetal growth. After Winchester and colleagues finding that a majority of US Women are exposed to glyphosate, the CDC and other investigators confirmed the findings and added additional adverse effects to the list including the additional impact of AMPA (the main metabolite of glyphosate), masculinization of female genitals and predisposition to fatty liver disease. With collaborator Mike Skinner from WSU, Dr. Winchester found that GLY induces epigenetic changes in exposed offspring which translated into "heritable" diseases such as obesity, perinatal mortality, and multiple disorders and has contributed numerous abstracts and presentations for more than 20 years to the annual Academic Society for Pediatrics, formerly SPR. He has a plethora of grants that have made much of his research possible. Dr. Winchester's work history includes serving as the Director of Neonatology at Memorial Hospital in Colorado Springs from 1981 to 1990 and a faculty role at the University of Colorado, where he shared his expertise by teaching clinical pediatric coursework from 1985 to 1986. He has more than 40 years practicing in Neonatology, founding two level III NICUS at Memorial Hospital in Colorado Springs, Colorado and Overland Park Regional Medical Center in Kansas where he directed four NICUS including one at Elliot Hospital, NH and St. Francis Hospital, IN. He is an esteemed member of numerous professional organizations, including the American Academy of Pediatrics where he is distinguished as a Fellow; District VIII Perinatal Medical Society; Subspecialty Board Neonatology at the American Academy of Pediatrics; and was a clinical instructor at the Department of Pediatrics at the University of Colorado and the University of Kansas (KUMC). Dr. Winchester has also received numerous distinctions and awards during his illustrious career including: Stanford Management Intern (SNIP) of the Year Award in 1968; graduated with honors from Stanford University in 1970; is a recipient of the Franklin P. Gengenbach Award for Best Pediatric Student in 1974-1975; March of Dimes "Make a Difference" Award in Greater Kansas City in 1991; Red Shoes Award at Riley Hospital in 2005; Indiana Public Health Association's Tony and Mary Hulman Achievement Award for Health Science Research in November 2013. The Top Doc Award in the Indianapolis Monthly Magazine in 2014, 2016-2021; Castle Connolly Top Doctor Award in 2016. Dr. Winchester is a highly sought-after professional and expert in the field and has served in many other capacities during his career including being a member of the NAS Multi-disciplinary Task Force at St. Francis Medical Center; founded and supported the Annual Perinatal Conference "Growth and Challenge" in Colorado Springs, Colorado; and supported as Clinical Advisor Research Fellowship by Amira Bastawisi, MD-Risk Factors for Premature Birth in Colorado Research tool developed by P.S. Winchester and Elizabeth Kyre. He has been an invited lecturer at numerous conferences including The Iowa Governor's Conference on Public Health where he was the keynote speaker and the Indianapolis Healthy Babies Consortium Meeting as a featured speaker. As a renowned researcher, with presentations from 2001-2024 at annual Academic Pediatric Society Meetings, Dr. Winchester has countless IRB's adding to the body of work supporting neonatal care and other medically relevant studies. He is both a mentor to numerous trainees, students and professionals and at the forefront of Pediatric and Neonatology research and development, saving countless lives and improving the odds for hundreds of infants and mothers. The doctor is a consummate supporter of the community including Greenwood High School Honors Biology Research Program with Becky Kehler (now in Sarasota County Schools, Fla). He worked with the Marion County Prosecutor's Office as a consultant and has supported Johnson County 4-H Fair as a Grand Champion in Artistic Painting. Looking ahead, Dr. Winchester envisions a future filled with continued growth and success in the field of neonatology and pediatrics. He is pursuing the next steps in protecting pregnant women from unwanted chemicals now contaminating them while pregnant. He explained, "Our discovery of glyphosate in most pregnant women is just one of a litany of chemicals now found in every life form on the planet. The capacity of these chemicals to alter the DNA of our offspring, inducing diseases across generations, is the next big challenge which we heretofore weren't aware of. Infertility is the worst of these chemicals' effects since it will lead to the inability of the human race to reproduce naturally if not altered." The doctor added that, "The privilege of treating sick newborns comes with the responsibility to find the origin of their diseases: preterm birth, birth defects, fetal growth restriction and their impact of cognitive and physical development of our children. Most chronic diseases today have their origins in ancestral environmental contaminants through epigenetic fetal changes. We are perfecting the means of keeping preterm babies alive, but they should never have to be born premature or sick in the first place. Our next big step is to provide the pharmacological, proteomic, probiotic, nutritional and medical, and psychological means to prepare women and their spouses for an optimal state of health before they become pregnant. This will include chemical surveillance, epigenetic and genetic surveillance and counseling, and may, one day, include modifiers for both genetic and epigenetic risk variants." Dr. Winchester's current primary research focuses on the role that prenatal herbicides impact the pregnancy, fetal development and long-term neuro-psychological development of exposed offspring including the potential role these contaminants have on childhood conditions such as autism spectrum disorder and attention, anxiety, depression disorders. His other research interests also include Physiological Maturation of the Neonate and Readiness for Discharge; III Neonatal Data Systems, Computerization of OB/Neonatal Data Base; and Sleep Study Program at Overland Park Regional Medical Center. Aside from Dr. Winchester's incredible career and influence in the medical field, he is a former athlete excelling in many sports including football where he was an All-State Athlete at Bozeman Senior High School and Division Champion in wrestling for Pacific Coast Small Colleges in 1967 at Lewis and Clark. He grew up on Winchester Angus Cattle Ranch in Bozeman, Montana. The doctor has more than 4 decades of extraordinary experiences, collaborating with national and international professionals. He has lived in Ankara, Turkey, studied in Tours, France and Edinburgh, Scotland, and speaks French, Spanish, and some German. While Dr. Winchester's professional achievements are indeed noteworthy, he considers his most gratifying accomplishment to be the extraordinary success of his four children, 3 grandchildren and counting, and wife, Deb, who remains his most important partner in life. Reflecting on his journey, Dr. Winchester acknowledges the influence of his parents, Burl Winchester and Carolyn Winchester; Mark Winchester MD (brother); Band director Percy Bronson; 4th grade teacher Mrs. Knoll; Wrestling and Football Coach Tom Le Prouse; Bozeman Senior High School; Del Weber, former President of California Teachers Association; Gordon Bower PhD Professor, Stanford University; Cy Gilbert director, Plans Programs American Airlines; Robert Bjork PhD Professor UCLA; Patrick O'Meara MD and Sharon Langendorfer MD at the University of Colorado Medical Center; Thomas Bouchard, University of Minnesota (Minnesota Twin Study); Ernie Beal MD Elliot Hospital; William Edwards MD, Dartmouth Medical School; James Lemons MD , former Chief Division of Neonatology Riley Hospital for Children and Indiana University School of Medicine, and early teachers who encouraged his pursuits. He also pays tribute to Dr. James A. Lemons, MD, the Chair of the Neonatal Department at the Indiana University School of Medicine, as a significant mentor who shaped his career along with his wife, Deb Winchester. Contact: Katherine Green, 516-825-5634, [email protected] SOURCE The Inner Circle