Document Detail


Enrollment of extremely low birth weight infants in a clinical research study may not be representative.
MedLine Citation:
PMID:  22371462     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-02-27
Journal Detail:
Title:  Pediatrics     Volume:  129     ISSN:  1098-4275     ISO Abbreviation:  Pediatrics     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-03-02     Completed Date:  2012-04-25     Revised Date:  2013-06-26    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  480-4     Citation Subset:  AIM; IM    
Affiliation:
University of California at San Diego, San Diego, California, USA. wrich@ucsd.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00233324
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / 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:
U10 HD053089/HD/NICHD NIH HHS; UL1 TR000041/TR/NCATS NIH HHS; UL1 TR000142/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Steroids
Investigator
Investigator/Affiliation:
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:
Pediatrics. 2012 Mar;129(3):576-8   [PMID:  22371469 ]

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