Estella M Alonso1, Wen Ye2, Kieran Hawthorne3, Veena Venkat4, Kathleen M Loomes5, Cara L Mack6, Paula M Hertel7, Saul J Karpen8, Nanda Kerkar9, Jean P Molleston10, Karen F Murray11, Rene Romero12, Philip Rosenthal13, Kathleen B Schwarz14, Benjamin L Shneider15, Frederick J Suchy16, Yumirle P Turmelle17, Kasper S Wang18, Averell H Sherker19, Ronald J Sokol6, Jorge A Bezerra20, John C Magee21. 1. Division of Gastroenterology, Hepatology, and Nutrition, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: ealonso@luriechildrens.org. 2. Department of Biostatistics, University of Michigan, Ann Arbor, MI. 3. Arbor Research Collaborative for Health, Ann Arbor, MI. 4. Children's Hospital of Pittsburgh, Pittsburgh, PA. 5. Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA. 6. Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO. 7. Pediatric Gastroenterology, Hepatology and Nutrition, Baylor College of Medicine, Houston, TX. 8. Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University School of Medicine/Children's Healthcare of Atlanta, Atlanta, GA. 9. Division of Pediatric Gastroenterology, Hepatology and Nutrition, Children's Hospital Los Angeles, University of Southern California, Los Angeles, CA; Division of Pediatric Gastroenterology, The Mount Sinai School of Medicine, New York, NY. 10. Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Indiana University School of Medicine, Rylie Hospital for Children, Indianapolis, IN. 11. Division of Gastroenterology and Hepatology, Department of Pediatrics, University of Washington and Seattle Children's, Seattle, WA. 12. Pediatrics, Emory University School of Medicine/Children's Healthcare of Atlanta, Atlanta, GA. 13. Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Francisco Benioff Children's Hospital, San Francisco, CA. 14. Johns Hopkins School of Medicine, Baltimore, MD. 15. Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Baylor College of Medicine, Houston, TX. 16. Children's Hospital Research Institute, Children's Hospital Colorado, Aurora, CO. 17. Washington University School of Medicine, St. Louis, MO. 18. Division of Pediatric Gastroenterology, Hepatology and Nutrition, Children's Hospital Los Angeles, University of Southern California, Los Angeles, CA. 19. Liver Diseases Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD. 20. Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH. 21. Department of Surgery, University of Michigan Medical School, Ann Arbor, MI.
Abstract
OBJECTIVE: To investigate the impact of corticosteroid therapy on the growth of participants in the Steroids in Biliary Atresia Randomized Trial (START) conducted through the Childhood Liver Disease Research Network. The primary analysis in START indicated that steroids did not have a beneficial effect on drainage in a cohort of infants with biliary atresia. We hypothesized that steroids would have a detrimental effect on growth in these infants. STUDY DESIGN:A total of 140 infants were enrolled in START, with 70 randomized to each treatment arm: steroid and placebo. Length, weight, and head circumference were obtained at baseline and follow-up visits to 24 months of age. RESULTS: Patients treated with steroids had significantly lower length and head circumference z scores during the first 3 months post-hepatoportoenterostomy (HPE), and significantly lower weight until 12 months. Growth trajectories in the steroid and placebo arms differed significantly for length (P < .0001), weight (P = .009), and head circumference (P < .0001) with the largest impact noted for those with successful HPE. Growth trajectory for head circumference was significantly lower in patients treated with steroids irrespective of HPE status, but recovered during the second 6 months of life. CONCLUSIONS:Steroid therapy following HPE in patients with biliary atresia is associated with impaired length, weight, and head circumference growth trajectories for at least 6 months post-HPE, especially impacting infants with successful bile drainage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00294684.
RCT Entities:
OBJECTIVE: To investigate the impact of corticosteroid therapy on the growth of participants in the Steroids in Biliary Atresia Randomized Trial (START) conducted through the Childhood Liver Disease Research Network. The primary analysis in START indicated that steroids did not have a beneficial effect on drainage in a cohort of infants with biliary atresia. We hypothesized that steroids would have a detrimental effect on growth in these infants. STUDY DESIGN: A total of 140 infants were enrolled in START, with 70 randomized to each treatment arm: steroid and placebo. Length, weight, and head circumference were obtained at baseline and follow-up visits to 24 months of age. RESULTS:Patients treated with steroids had significantly lower length and head circumference z scores during the first 3 months post-hepatoportoenterostomy (HPE), and significantly lower weight until 12 months. Growth trajectories in the steroid and placebo arms differed significantly for length (P < .0001), weight (P = .009), and head circumference (P < .0001) with the largest impact noted for those with successful HPE. Growth trajectory for head circumference was significantly lower in patients treated with steroids irrespective of HPE status, but recovered during the second 6 months of life. CONCLUSIONS:Steroid therapy following HPE in patients with biliary atresia is associated with impaired length, weight, and head circumference growth trajectories for at least 6 months post-HPE, especially impacting infants with successful bile drainage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00294684.
Authors: Riccardo Superina; John C Magee; Mary L Brandt; Patrick J Healey; Greg Tiao; Fred Ryckman; Frederick M Karrer; Kishore Iyer; Annie Fecteau; Karen West; R Cartland Burns; Alan Flake; Hanmin Lee; Jeff A Lowell; Pat Dillon; Paul Colombani; Richard Ricketts; Yun Li; Jeffrey Moore; Kasper S Wang Journal: Ann Surg Date: 2011-10 Impact factor: 12.969
Authors: S E Chin; R W Shepherd; B J Thomas; G J Cleghorn; M K Patrick; J A Wilcox; T H Ong; S V Lynch; R Strong Journal: Am J Clin Nutr Date: 1992-07 Impact factor: 7.045
Authors: Ronald J Sokol; Ross W Shepherd; Riccardo Superina; Jorge A Bezerra; Patricia Robuck; Jay H Hoofnagle Journal: Hepatology Date: 2007-08 Impact factor: 17.425
Authors: Joachim F Kuebler; Omid Madadi-Sanjani; Eva D Pfister; Ulrich Baumann; David Fortmann; Johannes Leonhardt; Benno M Ure; Michael P Manns; Richard Taubert; Claus Petersen Journal: J Clin Med Date: 2021-12-09 Impact factor: 4.241