PMID- 22371462 OWN - NLM STAT- MEDLINE DCOM- 20120425 LR - 20211021 IS - 1098-4275 (Electronic) IS - 0031-4005 (Print) IS - 0031-4005 (Linking) VI - 129 IP - 3 DP - 2012 Mar TI - Enrollment of extremely low birth weight infants in a clinical research study may not be representative. PG - 480-4 LID - 10.1542/peds.2011-2121 [doi] AB - 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. FAU - Rich, Wade AU - Rich W AD - University of California at San Diego, San Diego, California, USA. wrich@ucsd.edu FAU - Finer, Neil N AU - Finer NN FAU - Gantz, Marie G AU - Gantz MG FAU - Newman, Nancy S AU - Newman NS FAU - Hensman, Angelita M AU - Hensman AM FAU - Hale, Ellen C AU - Hale EC FAU - Auten, Kathy J AU - Auten KJ FAU - Schibler, Kurt AU - Schibler K FAU - Faix, Roger G AU - Faix RG FAU - Laptook, Abbot R AU - Laptook AR FAU - Yoder, Bradley A AU - Yoder BA FAU - Das, Abhik AU - Das A FAU - Shankaran, Seetha AU - Shankaran S CN - SUPPORT and Generic Database Subcommittees of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network LA - eng SI - ClinicalTrials.gov/NCT00233324 GR - U10 HD021385/HD/NICHD NIH HHS/United States GR - U10 HD053124/HD/NICHD NIH HHS/United States GR - U10 HD053119/HD/NICHD NIH HHS/United States GR - U10 HD021364/HD/NICHD NIH HHS/United States GR - U10 HD027871/HD/NICHD NIH HHS/United States GR - UL1 RR025744/RR/NCRR NIH HHS/United States GR - UL1 RR025008/RR/NCRR NIH HHS/United States GR - U10 HD040498/HD/NICHD NIH HHS/United States GR - U10 HD027856/HD/NICHD NIH HHS/United States GR - U10 HD021373/HD/NICHD NIH HHS/United States GR - UL1 RR024139/RR/NCRR NIH HHS/United States GR - U10 HD027880/HD/NICHD NIH HHS/United States GR - U10 HD040521/HD/NICHD NIH HHS/United States GR - U10 HD053109/HD/NICHD NIH HHS/United States GR - M01 RR008084/RR/NCRR NIH HHS/United States GR - UL1 TR001449/TR/NCATS NIH HHS/United States GR - UG1 HD053089/HD/NICHD NIH HHS/United States GR - U10 HD040461/HD/NICHD NIH HHS/United States GR - M01 RR016587/RR/NCRR NIH HHS/United States GR - U10 HD040689/HD/NICHD NIH HHS/United States GR - U10 HD040492/HD/NICHD NIH HHS/United States GR - U10 HD027853/HD/NICHD NIH HHS/United States GR - U10 HD027904/HD/NICHD NIH HHS/United States GR - U10 HD021397/HD/NICHD NIH HHS/United States GR - UL1 TR000041/TR/NCATS NIH HHS/United States GR - M01 RR007122/RR/NCRR NIH HHS/United States GR - U10 HD027851/HD/NICHD NIH HHS/United States GR - U10 HD034216/HD/NICHD NIH HHS/United States GR - U10 HD036790/HD/NICHD NIH HHS/United States GR - M01 RR006022/RR/NCRR NIH HHS/United States GR - U10 HD053089/HD/NICHD NIH HHS/United States GR - UL1 RR024979/RR/NCRR NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20120227 PL - United States TA - Pediatrics JT - Pediatrics JID - 0376422 RN - 0 (Steroids) SB - IM CIN - Pediatrics. 2012 Mar;129(3):576-8. PMID: 22371469 MH - Abnormalities, Drug-Induced/diagnosis/mortality/*therapy MH - Adult MH - Bronchopulmonary Dysplasia/diagnosis/mortality/therapy MH - Ductus Arteriosus, Patent/diagnosis/mortality/therapy MH - *Eligibility Determination MH - Evaluation Studies as Topic MH - Female MH - Humans MH - *Infant, Extremely Low Birth Weight MH - Infant, Newborn MH - Infant, Premature, Diseases/diagnosis/*mortality/*therapy MH - Leukomalacia, Periventricular/diagnosis/mortality/therapy MH - Male MH - Multivariate Analysis MH - Patient Selection MH - Pregnancy MH - Prenatal Care/methods MH - Reference Values MH - Retinopathy of Prematurity/diagnosis/mortality/therapy MH - Risk Assessment MH - Sensitivity and Specificity MH - Steroids/administration & dosage/*adverse effects MH - Survival Analysis MH - Treatment Outcome PMC - PMC3289530 FIR - Jobe, Alan H IR - Jobe AH FIR - Caplan, Michael S IR - Caplan MS FIR - Oh, William IR - Oh W FIR - Gingras, Dan IR - Gingras D FIR - Barnett, Susan IR - Barnett S FIR - Lillie, Sarah IR - Lillie S FIR - Francis, Kim IR - Francis K FIR - Andrews, Dawn IR - Andrews D FIR - Angela, Kristen IR - Angela K FIR - Walsh, Michele C IR - Walsh MC FIR - Fanaroff, Avroy A IR - Fanaroff AA FIR - Siner, Bonnie S IR - Siner BS FIR - Narendran, Vivek IR - Narendran V FIR - Bridges, Kate IR - Bridges K FIR - Alexander, Barbara IR - Alexander B FIR - Grisby, Cathy IR - Grisby C FIR - Mersmann, Marcia Worley IR - Mersmann MW FIR - Mincey, Holly L IR - Mincey HL FIR - Hessling, Jody IR - Hessling J FIR - Cotten, C Michael IR - Cotten C FIR - Goldberg, Ronald N IR - Goldberg RN FIR - Fisher, Kimberly A IR - Fisher KA FIR - Foy, Katherine A IR - Foy KA FIR - Siaw, Gloria IR - Siaw G FIR - Stoll, Barbara J IR - Stoll BJ FIR - Buchter, Susie IR - Buchter S FIR - Piazza, Anthony IR - Piazza A FIR - Carlton, David P IR - Carlton DP FIR - Blackwelder, Ann M IR - Blackwelder AM FIR - Higgins, Rosemary D IR - Higgins RD FIR - Archer, Stephanie Wilson IR - Archer SW FIR - Poindexter, Brenda B IR - Poindexter BB FIR - Lemons, James A IR - Lemons JA FIR - Hamer, Faithe IR - Hamer F FIR - Herron, Dianne E IR - Herron DE FIR - Miller, Lucy C IR - Miller LC FIR - Wilson, Leslie D IR - Wilson LD FIR - Berberich, Mary Anne IR - Berberich MA FIR - Blaisdell, Carol J IR - Blaisdell CJ FIR - Gail, Dorothy B IR - Gail DB FIR - Kiley, James P IR - Kiley JP FIR - Poole, W Kenneth IR - Poole W FIR - Cunningham, Margaret IR - Cunningham M FIR - Hastings, Betty K IR - Hastings BK FIR - Irene, Amanda R IR - Irene AR FIR - Auman, Jeanette O'Donnell IR - Auman JO FIR - Huitema, Carolyn Petrie IR - Huitema CP FIR - Pickett, James W 2nd IR - Pickett JW 2nd FIR - Wallace, Dennis IR - Wallace D FIR - Zaterka-Baxter, Kristin M IR - Zaterka-Baxter KM FIR - Van Meurs, Krisa P IR - Van Meurs KP FIR - Stevenson, David K IR - Stevenson DK FIR - Ball, M Bethany IR - Ball M FIR - Proud, Melinda S IR - Proud MS FIR - Frantz, Ivan D 3rd IR - Frantz ID 3rd FIR - Fiascone, John M IR - Fiascone JM FIR - Furey, Anne IR - Furey A FIR - MacKinnon, Brenda L IR - MacKinnon BL FIR - Nylen, Ellen IR - Nylen E FIR - Carlo, Waldemar A IR - Carlo WA FIR - Ambalavanan, Namasivayam IR - Ambalavanan N FIR - Collins, Monica V IR - Collins MV FIR - Cosby, Shirley S IR - Cosby SS FIR - Phillips, Vivien A IR - Phillips VA FIR - Rasmussen, Maynard R IR - Rasmussen MR FIR - Wozniak, Paul R IR - Wozniak PR FIR - Arnell, Kathy IR - Arnell K FIR - Bridge, Renee IR - Bridge R FIR - Demetrio, Clarence IR - Demetrio C FIR - Bell, Edward F IR - Bell EF FIR - Widness, John A IR - Widness JA FIR - Klein, Jonathan M IR - Klein JM FIR - Johnson, Karen J IR - Johnson KJ FIR - Duara, Shahnaz IR - Duara S FIR - Everett-Thomas, Ruth IR - Everett-Thomas R FIR - Watterberg, Kristi L IR - Watterberg KL FIR - Ohls, Robin K IR - Ohls RK FIR - Rohr, Julie IR - Rohr J FIR - Lacy, Conra Backstrom IR - Lacy CB FIR - Laroia, Nirupama IR - Laroia N FIR - Phelps, Dale L IR - Phelps DL FIR - Reubens, Linda J IR - Reubens LJ FIR - Burnell, Erica IR - Burnell E FIR - Sanchez, Pablo J IR - Sanchez PJ FIR - Rosenfeld, Charles R IR - Rosenfeld CR FIR - Salhab, Walid A IR - Salhab WA FIR - Allen, James IR - Allen J FIR - Guzman, Alicia IR - Guzman A FIR - Hensley, Gaynelle IR - Hensley G FIR - Lepps, Melissa H IR - Lepps MH FIR - Martin, Melissa IR - Martin M FIR - Miller, Nancy A IR - Miller NA FIR - Solis, Araceli IR - Solis A FIR - Vasil, Diana M IR - Vasil DM FIR - Wilder, Kerry IR - Wilder K FIR - Kennedy, Kathleen A IR - Kennedy KA FIR - Tyson, Jon E IR - Tyson JE FIR - Morris, Brenda H IR - Morris BH FIR - Harris, Beverly Foley IR - Harris BF FIR - Lis, Anna E IR - Lis AE FIR - Martin, Sarah IR - Martin S FIR - McDavid, Georgia E IR - McDavid GE FIR - Tate, Patti L IR - Tate PL FIR - Wright, Sharon L IR - Wright SL FIR - Burnett, Jill IR - Burnett J FIR - Jensen, Jennifer J IR - Jensen JJ FIR - Osborne, Karen A IR - Osborne KA FIR - Spencer, Cynthia IR - Spencer C FIR - Weaver-Lewis, Kimberlee IR - Weaver-Lewis K FIR - O'Shea, T Michael IR - O'Shea T FIR - Peters, Nancy J IR - Peters NJ FIR - Sood, Beena G IR - Sood BG FIR - Bara, Rebecca IR - Bara R FIR - Billian, Elizabeth IR - Billian E FIR - Johnson, Mary IR - Johnson M FIR - Bhandari, Vineet IR - Bhandari V FIR - Ehrenkranz, Richard A IR - Ehrenkranz RA FIR - Jacobs, Harris C IR - Jacobs HC FIR - Cervone, Pat IR - Cervone P FIR - Gettner, Patricia IR - Gettner P FIR - Konstantino, Monica IR - Konstantino M FIR - Poulsen, JoAnn IR - Poulsen J FIR - Taft, Janet IR - Taft J EDAT- 2012/03/01 06:00 MHDA- 2012/04/26 06:00 PMCR- 2013/03/01 CRDT- 2012/02/29 06:00 PHST- 2012/02/29 06:00 [entrez] PHST- 2012/03/01 06:00 [pubmed] PHST- 2012/04/26 06:00 [medline] PHST- 2013/03/01 00:00 [pmc-release] AID - peds.2011-2121 [pii] AID - 10.1542/peds.2011-2121 [doi] PST - ppublish SO - Pediatrics. 2012 Mar;129(3):480-4. doi: 10.1542/peds.2011-2121. Epub 2012 Feb 27.