Impact of Steroid Therapy on Early Growth in Infants with Biliary Atresia: The Multicenter Steroids in Biliary Atresia Randomized Trial
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 drai...
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Published in | The Journal of pediatrics Vol. 202; pp. 179 - 185.e4 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Elsevier Inc
01.11.2018
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Abstract | 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.
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.
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.
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.
ClinicalTrials.gov: NCT00294684. |
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AbstractList | 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.
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.
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.
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.
ClinicalTrials.gov: NCT00294684. |
Author | Loomes, Kathleen M. Alonso, Estella M. Hawthorne, Kieran Schwarz, Kathleen B. Karpen, Saul J. Magee, John C. Suchy, Frederick J. Murray, Karen F. Wang, Kasper S. Shneider, Benjamin L. Molleston, Jean P. Turmelle, Yumirle P. Venkat, Veena Bezerra, Jorge A. Mack, Cara L. Hertel, Paula M. Kerkar, Nanda Sokol, Ronald J. Romero, Rene Rosenthal, Philip Sherker, Averell H. Ye, Wen |
Author_xml | – sequence: 1 givenname: Estella M. surname: Alonso fullname: Alonso, Estella M. email: ealonso@luriechildrens.org organization: Division of Gastroenterology, Hepatology, and Nutrition, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL – sequence: 2 givenname: Wen surname: Ye fullname: Ye, Wen organization: Department of Biostatistics, University of Michigan, Ann Arbor, MI – sequence: 3 givenname: Kieran surname: Hawthorne fullname: Hawthorne, Kieran organization: Arbor Research Collaborative for Health, Ann Arbor, MI – sequence: 4 givenname: Veena surname: Venkat fullname: Venkat, Veena organization: Children's Hospital of Pittsburgh, Pittsburgh, PA – sequence: 5 givenname: Kathleen M. surname: Loomes fullname: Loomes, Kathleen M. organization: Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Philadelphia, PA – sequence: 6 givenname: Cara L. surname: Mack fullname: Mack, Cara L. organization: Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO – sequence: 7 givenname: Paula M. surname: Hertel fullname: Hertel, Paula M. organization: Pediatric Gastroenterology, Hepatology and Nutrition, Baylor College of Medicine, Houston, TX – sequence: 8 givenname: Saul J. surname: Karpen fullname: Karpen, Saul J. organization: Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Emory University School of Medicine/Children's Healthcare of Atlanta, Atlanta, GA – sequence: 9 givenname: Nanda surname: Kerkar fullname: Kerkar, Nanda organization: Division of Pediatric Gastroenterology, Hepatology and Nutrition, Children's Hospital Los Angeles, University of Southern California, Los Angeles, CA – sequence: 10 givenname: Jean P. surname: Molleston fullname: Molleston, Jean P. organization: Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Indiana University School of Medicine, Rylie Hospital for Children, Indianapolis, IN – sequence: 11 givenname: Karen F. surname: Murray fullname: Murray, Karen F. organization: Division of Gastroenterology and Hepatology, Department of Pediatrics, University of Washington and Seattle Children's, Seattle, WA – sequence: 12 givenname: Rene surname: Romero fullname: Romero, Rene organization: Pediatrics, Emory University School of Medicine/Children's Healthcare of Atlanta, Atlanta, GA – sequence: 13 givenname: Philip surname: Rosenthal fullname: Rosenthal, Philip organization: Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of California, San Francisco Benioff Children's Hospital, San Francisco, CA – sequence: 14 givenname: Kathleen B. surname: Schwarz fullname: Schwarz, Kathleen B. organization: Johns Hopkins School of Medicine, Baltimore, MD – sequence: 15 givenname: Benjamin L. surname: Shneider fullname: Shneider, Benjamin L. organization: Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, Baylor College of Medicine, Houston, TX – sequence: 16 givenname: Frederick J. surname: Suchy fullname: Suchy, Frederick J. organization: Children's Hospital Research Institute, Children's Hospital Colorado, Aurora, CO – sequence: 17 givenname: Yumirle P. surname: Turmelle fullname: Turmelle, Yumirle P. organization: Washington University School of Medicine, St. Louis, MO – sequence: 18 givenname: Kasper S. surname: Wang fullname: Wang, Kasper S. organization: Division of Pediatric Gastroenterology, Hepatology and Nutrition, Children's Hospital Los Angeles, University of Southern California, Los Angeles, CA – sequence: 19 givenname: Averell H. orcidid: 0000-0003-0409-6938 surname: Sherker fullname: Sherker, Averell H. organization: Liver Diseases Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD – sequence: 20 givenname: Ronald J. surname: Sokol fullname: Sokol, Ronald J. organization: Section of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Colorado School of Medicine, Children's Hospital Colorado, Aurora, CO – sequence: 21 givenname: Jorge A. surname: Bezerra fullname: Bezerra, Jorge A. organization: Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH – sequence: 22 givenname: John C. surname: Magee fullname: Magee, John C. organization: Department of Surgery, University of Michigan Medical School, Ann Arbor, MI |
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Keywords | chronic liver disease START HPE ChiLDReN sarcopenia failure to thrive |
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SubjectTerms | Adrenal Cortex Hormones - adverse effects Adrenal Cortex Hormones - therapeutic use Biliary Atresia - drug therapy Biliary Atresia - mortality Biliary Atresia - surgery Body Weight - drug effects Cephalometry - methods Child Development - drug effects Child Development - physiology Child, Preschool chronic liver disease Double-Blind Method failure to thrive Failure to Thrive - chemically induced Failure to Thrive - epidemiology Failure to Thrive - physiopathology Female Follow-Up Studies Humans Infant Male Monitoring, Physiologic - methods Portoenterostomy, Hepatic - methods Portoenterostomy, Hepatic - mortality Postoperative Care - methods Prospective Studies Reference Values Risk Assessment sarcopenia Sarcopenia - chemically induced Sarcopenia - epidemiology Sarcopenia - physiopathology Time Factors Treatment Outcome |
Title | Impact of Steroid Therapy on Early Growth in Infants with Biliary Atresia: The Multicenter Steroids in Biliary Atresia Randomized Trial |
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