| Enrollment of extremely low birth weight infants in a clinical research study may not be representative. | |
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MedLine Citation:
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PMID: 22371462 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND OBJECTIVE: The Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT) antenatal consent study demonstrated that mothers of infants enrolled in the SUPPORT trial had significantly different demographics and exposure to antenatal steroids compared with mothers of eligible, but not enrolled infants. The objective of this analysis was to compare the outcomes of bronchopulmonary dysplasia, severe retinopathy of prematurity, severe intraventricular hemorrhage or periventricular leukomalacia (IVH/PVL), death, and death/severe IVH/PVL for infants enrolled in SUPPORT in comparison with eligible, but not enrolled infants. METHODS: Perinatal characteristics and neonatal outcomes were compared for enrolled and eligible but not enrolled infants in bivariate analyses. Models were created to test the effect of enrollment in SUPPORT on outcomes, controlling for perinatal characteristics. RESULTS: There were 1316 infants enrolled in SUPPORT; 3053 infants were eligible, but not enrolled. In unadjusted analyses, enrolled infants had significantly lower rates of death before discharge, severe IVH/PVL, death/severe IVH/PVL (all < 0.001), and bronchopulmonary dysplasia (P = .003) in comparison with eligible, but not enrolled infants. The rate of severe retinopathy of prematurity was not significantly different. After adjustment for perinatal factors, enrollment in the trial was not a significant predictor of any of the tested clinical outcomes. CONCLUSIONS: The results of this analysis demonstrate significant outcome differences between enrolled and eligible but not enrolled infants in a trial using antenatal consent, which were likely due to enrollment bias resulting from the antenatal consent process. Additional research and regulatory review need to be conducted to ensure that large moderate-risk trials that require antenatal consent can be conducted in such a way as to ensure the generalizability of results. |
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Authors:
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Wade Rich; Neil N Finer; Marie G Gantz; Nancy S Newman; Angelita M Hensman; Ellen C Hale; Kathy J Auten; Kurt Schibler; Roger G Faix; Abbot R Laptook; Bradley A Yoder; Abhik Das; Seetha Shankaran; |
Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural Date: 2012-02-27 |
Journal Detail:
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Title: Pediatrics Volume: 129 ISSN: 1098-4275 ISO Abbreviation: Pediatrics Publication Date: 2012 Mar |
Date Detail:
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Created Date: 2012-03-02 Completed Date: 2012-04-25 Revised Date: 2013-05-06 |
Medline Journal Info:
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Nlm Unique ID: 0376422 Medline TA: Pediatrics Country: United States |
Other Details:
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Languages: eng Pagination: 480-4 Citation Subset: AIM; IM |
Affiliation:
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University of California at San Diego, San Diego, California, USA. wrich@ucsd.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00233324 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Abnormalities, Drug-Induced
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diagnosis,
mortality,
therapy* Adult Bronchopulmonary Dysplasia / diagnosis, mortality, therapy Ductus Arteriosus, Patent / diagnosis, mortality, therapy Eligibility Determination* Evaluation Studies as Topic Female Humans Infant, Extremely Low Birth Weight* Infant, Newborn Infant, Premature, Diseases / diagnosis, mortality*, therapy* Leukomalacia, Periventricular / diagnosis, mortality, therapy Male Multivariate Analysis Patient Selection Pregnancy Prenatal Care / methods Reference Values Retinopathy of Prematurity / diagnosis, mortality, therapy Risk Assessment Sensitivity and Specificity Steroids / administration & dosage, adverse effects* Survival Analysis Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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U10 HD053089/HD/NICHD NIH HHS; UL1 TR000041/TR/NCATS NIH HHS; UL1 TR000142/TR/NCATS NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Steroids |
| Investigator | |
Investigator/Affiliation:
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Alan H Jobe / ; Michael S Caplan / ; William Oh / ; Dan Gingras / ; Susan Barnett / ; Sarah Lillie / ; Kim Francis / ; Dawn Andrews / ; Kristen Angela / ; Michele C Walsh / ; Avroy A Fanaroff / ; Bonnie S Siner / ; Vivek Narendran / ; Kate Bridges / ; Barbara Alexander / ; Cathy Grisby / ; Marcia Worley Mersmann / ; Holly L Mincey / ; Jody Hessling / ; C Michael Cotten / ; Ronald N Goldberg / ; Kimberly A Fisher / ; Katherine A Foy / ; Gloria Siaw / ; Barbara J Stoll / ; Susie Buchter / ; Anthony Piazza / ; David P Carlton / ; Ann M Blackwelder / ; Rosemary D Higgins / ; Stephanie Wilson Archer / ; Brenda B Poindexter / ; James A Lemons / ; Faithe Hamer / ; Dianne E Herron / ; Lucy C Miller / ; Leslie D Wilson / ; Mary Anne Berberich / ; Carol J Blaisdell / ; Dorothy B Gail / ; James P Kiley / ; W Kenneth Poole / ; Margaret Cunningham / ; Betty K Hastings / ; Amanda R Irene / ; Jeanette O'Donnell Auman / ; Carolyn Petrie Huitema / ; James W Pickett / ; Dennis Wallace / ; Kristin M Zaterka-Baxter / ; Krisa P Van Meurs / ; David K Stevenson / ; M Bethany Ball / ; Melinda S Proud / ; Ivan D Frantz / ; John M Fiascone / ; Anne Furey / ; Brenda L MacKinnon / ; Ellen Nylen / ; Waldemar A Carlo / ; Namasivayam Ambalavanan / ; Monica V Collins / ; Shirley S Cosby / ; Vivien A Phillips / ; Maynard R Rasmussen / ; Paul R Wozniak / ; Kathy Arnell / ; Renee Bridge / ; Clarence Demetrio / ; Edward F Bell / ; John A Widness / ; Jonathan M Klein / ; Karen J Johnson / ; Shahnaz Duara / ; Ruth Everett-Thomas / ; Kristi L Watterberg / ; Robin K Ohls / ; Julie Rohr / ; Conra Backstrom Lacy / ; Nirupama Laroia / ; Dale L Phelps / ; Linda J Reubens / ; Erica Burnell / ; Pablo J Sánchez / ; Charles R Rosenfeld / ; Walid A Salhab / ; James Allen / ; Alicia Guzman / ; Gaynelle Hensley / ; Melissa H Lepps / ; Melissa Martin / ; Nancy A Miller / ; Araceli Solis / ; Diana M Vasil / ; Kerry Wilder / ; Kathleen A Kennedy / ; Jon E Tyson / ; Brenda H Morris / ; Beverly Foley Harris / ; Anna E Lis / ; Sarah Martin / ; Georgia E McDavid / ; Patti L Tate / ; Sharon L Wright / ; Jill Burnett / ; Jennifer J Jensen / ; Karen A Osborne / ; Cynthia Spencer / ; Kimberlee Weaver-Lewis / ; T Michael O'Shea / ; Nancy J Peters / ; Beena G Sood / ; Rebecca Bara / ; Elizabeth Billian / ; Mary Johnson / ; Vineet Bhandari / ; Richard A Ehrenkranz / ; Harris C Jacobs / ; Pat Cervone / ; Patricia Gettner / ; Monica Konstantino / ; JoAnn Poulsen / ; Janet Taft / |
| Comments/Corrections | |
Comment In:
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Pediatrics. 2012 Mar;129(3):576-8
[PMID:
22371469
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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