PMID- 20587676
OWN - NLM
STAT- MEDLINE
DCOM- 20100728
LR  - 20211020
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Print)
IS  - 0031-4005 (Linking)
VI  - 126
IP  - 1
DP  - 2010 Jul
TI  - Antenatal consent in the SUPPORT trial: challenges, costs, and representative 
      enrollment.
PG  - e215-21
LID - 10.1542/peds.2009-3353 [doi]
AB  - OBJECTIVES: The purposes of this study were to quantify the time and effort 
      involved in obtaining prenatal consent for the Neonatal Research Network 
      Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT) 
      and to determine whether the enrolled infants were representative of the eligible 
      population. METHODS: Eligible subjects were likely to deliver in the SUPPORT 
      gestational age window (24-27(6/7)] weeks). Data included who approached the 
      subjects for consent, how often they approached, the duration of each contact, 
      whether consent was obtained, and whether subjects were enrolled in the trial. 
      Eligible, nonenrolled infants entered into the Neonatal Research Network Generic 
      Database throughout the period of SUPPORT enrollment were compared with enrolled 
      infants. RESULTS: A total of 2826 women were identified at 18 sites, 2228 were 
      approached for consent, and 1219 (54.7%) agreed. For 76.9% of those approached, 
      <3 visits (mean: 2.0 +/- 1.2 visits) were required to complete the consent 
      process. Of the 659 infants with consent who were delivered within the study 
      window, 611 were enrolled. Mothers who received a neonatal consultation were more 
      likely to give consent (P < .001). The proportion of infants not exposed to 
      steroids was significantly greater in the nonapproached group than in the 
      approached group (20.0% vs 3.4%; P < .0001). CONCLUSION: In a trial that involved 
      preterm infants and required prenatal consent, >5 women were identified as being 
      likely to deliver in the SUPPORT gestational age window for each 1 who delivered 
      an enrolled infant.
FAU - Rich, Wade D
AU  - Rich WD
AD  - Department of Pediatrics, School of Medicine, University of California, San 
      Diego, California, USA. wrich@ucsd.edu
FAU - Auten, Kathy J
AU  - Auten KJ
FAU - Gantz, Marie G
AU  - Gantz MG
FAU - Hale, Ellen C
AU  - Hale EC
FAU - Hensman, Angelita M
AU  - Hensman AM
FAU - Newman, Nancy S
AU  - Newman NS
FAU - Finer, Neil N
AU  - Finer NN
CN  - National Institute of Child Health and Human Development Neonatal Research 
      Network
LA  - eng
GR  - U10 HD27851/HD/NICHD NIH HHS/United States
GR  - UL1 RR025761/RR/NCRR NIH HHS/United States
GR  - U10 HD021364/HD/NICHD NIH HHS/United States
GR  - U10 HD40521/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR59/RR/NCRR NIH HHS/United States
GR  - U10 HD040461-05S1/HD/NICHD NIH HHS/United States
GR  - U10 HD21373/HD/NICHD NIH HHS/United States
GR  - UL1 RR025008/RR/NCRR NIH HHS/United States
GR  - U10 HD21385/HD/NICHD NIH HHS/United States
GR  - CTSA UL1 RR24139/RR/NCRR NIH HHS/United States
GR  - U10 HD027856/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR64/RR/NCRR NIH HHS/United States
GR  - U10 HD021373/HD/NICHD NIH HHS/United States
GR  - K23 HD041423/HD/NICHD NIH HHS/United States
GR  - UL1 RR024139/RR/NCRR NIH HHS/United States
GR  - CTSA UL1 RR24979/RR/NCRR NIH HHS/United States
GR  - U10 HD40689/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR750/RR/NCRR NIH HHS/United States
GR  - U10 HD021385/HD/NICHD NIH HHS/United States
GR  - UL1 RR025764/RR/NCRR NIH HHS/United States
GR  - U10 HD40492/HD/NICHD NIH HHS/United States
GR  - U10 HD53119/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR32/RR/NCRR NIH HHS/United States
GR  - GCRC M01 RR997/RR/NCRR NIH HHS/United States
GR  - GCRC M01 RR7122/RR/NCRR NIH HHS/United States
GR  - U10 HD053124/HD/NICHD NIH HHS/United States
GR  - U10 HD053119/HD/NICHD NIH HHS/United States
GR  - U01 HD036790/HD/NICHD NIH HHS/United States
GR  - U10 HD53124/HD/NICHD NIH HHS/United States
GR  - U10 HD21364/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR39/RR/NCRR NIH HHS/United States
GR  - U10 HD34216/HD/NICHD NIH HHS/United States
GR  - GCRC MO1 RR125/RR/NCRR NIH HHS/United States
GR  - GCRC M01 RR80/RR/NCRR NIH HHS/United States
GR  - U10 HD027880/HD/NICHD NIH HHS/United States
GR  - CTSA UL1 RR25764/RR/NCRR NIH HHS/United States
GR  - U10 HD040521/HD/NICHD NIH HHS/United States
GR  - U10 HD053109/HD/NICHD NIH HHS/United States
GR  - U10 HD27880/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 HD27904/HD/NICHD NIH HHS/United States
GR  - CTSA UL1 RR25761/RR/NCRR NIH HHS/United States
GR  - U10 HD53109/HD/NICHD NIH HHS/United States
GR  - U10 HD040461/HD/NICHD NIH HHS/United States
GR  - U10 HD40498/HD/NICHD NIH HHS/United States
GR  - M01 RR016587/RR/NCRR NIH HHS/United States
GR  - U10 HD53089/HD/NICHD NIH HHS/United States
GR  - U10 HD27871/HD/NICHD NIH HHS/United States
GR  - U10 HD040689/HD/NICHD NIH HHS/United States
GR  - U10 HD040492/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR6022/RR/NCRR NIH HHS/United States
GR  - GCRC M01 RR70/RR/NCRR NIH HHS/United States
GR  - U10 HD027853/HD/NICHD NIH HHS/United States
GR  - U10 HD027904/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR633/RR/NCRR NIH HHS/United States
GR  - U10 HD021397/HD/NICHD NIH HHS/United States
GR  - U10 HD27856/HD/NICHD NIH HHS/United States
GR  - U10 HD40461/HD/NICHD NIH HHS/United States
GR  - U10 HD27853/HD/NICHD NIH HHS/United States
GR  - CTSA UL1 RR25744/RR/NCRR NIH HHS/United States
GR  - UL1 TR000454/TR/NCATS NIH HHS/United States
GR  - U10 HD027871/HD/NICHD NIH HHS/United States
GR  - UL1 RR025744/RR/NCRR NIH HHS/United States
GR  - GCRC M01 RR8084/RR/NCRR NIH HHS/United States
GR  - GCRC M01 RR16587/RR/NCRR 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  - GCRC M01 RR44/RR/NCRR NIH HHS/United States
GR  - GCRC M01 RR30/RR/NCRR NIH HHS/United States
GR  - U10 HD21397/HD/NICHD NIH HHS/United States
GR  - U01 HD36790/HD/NICHD NIH HHS/United States
GR  - R01 FD004793/FD/FDA HHS/United States
GR  - U10 HD034216/HD/NICHD NIH HHS/United States
GR  - GCRC M01 RR54/RR/NCRR NIH HHS/United States
GR  - CTSA UL1 RR25008/RR/NCRR NIH HHS/United States
GR  - U10 HD040498/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  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20100629
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Pulmonary Surfactants)
SB  - IM
MH  - Cohort Studies
MH  - Cost-Benefit Analysis
MH  - Female
MH  - Gestational Age
MH  - Humans
MH  - Infant, Newborn
MH  - *Infant, Premature
MH  - Infant, Premature, Diseases/diagnosis/therapy
MH  - Informed Consent/*statistics & numerical data
MH  - Intention to Treat Analysis
MH  - Male
MH  - Oximetry/methods
MH  - Patient Compliance
MH  - Patient Selection
MH  - Positive-Pressure Respiration
MH  - Pregnancy
MH  - Prenatal Diagnosis/*economics/*methods
MH  - Probability
MH  - Prospective Studies
MH  - Pulmonary Surfactants/analysis
MH  - Randomized Controlled Trials as Topic
PMC - PMC3057215
MID - NIHMS272379
FIR - Jobe, Alan H
IR  - Jobe AH
FIR - Caplan, Michael S
IR  - Caplan MS
FIR - Walsh, Michele C
IR  - Walsh MC
FIR - Fanaroff, Avroy A
IR  - Fanaroff AA
FIR - Newman, Nancy S
IR  - Newman NS
FIR - Siner, Bonnie S
IR  - Siner BS
FIR - Schibler, Kurt
IR  - Schibler K
FIR - Donovan, Edward F
IR  - Donovan EF
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 - Goldberg, Ronald N
IR  - Goldberg RN
FIR - Cotten, C Michael
IR  - Cotten CM
FIR - Auten, Kathy J
IR  - Auten KJ
FIR - Fischer, Kimberly A
IR  - Fischer 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 - Hale, Ellen C
IR  - Hale EC
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 - Appel, Diana D
IR  - Appel DD
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 - Das, Abhik
IR  - Das A
FIR - Poole, W Kenneth
IR  - Poole WK
FIR - Gantz, Marie
IR  - Gantz M
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 - 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 MB
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 - Finer, Neil N
IR  - Finer NN
FIR - Rasmussen, Maynard R
IR  - Rasmussen MR
FIR - Wozniak, Paul R
IR  - Wozniak PR
FIR - Arnell, Kathy
IR  - Arnell K
FIR - Demetrio, Clarence
IR  - Demetrio C
FIR - Rich, Wade
IR  - Rich W
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 - Laroira, Nirupama
IR  - Laroira 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 - Guzman, Alicia
IR  - Guzman A
FIR - Hensley, Gaynelle
IR  - Hensley G
FIR - Lepps, Melissa H
IR  - Lepps MH
FIR - Miller, Nancy A
IR  - Miller NA
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 Pierce
IR  - Tate PP
FIR - Wright, Sharon L
IR  - Wright SL
FIR - Faix, Roger G
IR  - Faix RG
FIR - Yoder, Bradley A
IR  - Yoder BA
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 TM
FIR - Peters, Nancy J
IR  - Peters NJ
FIR - Shankaran, Seetha
IR  - Shankaran S
FIR - Sood, Beena
IR  - Sood B
FIR - Bara, Rebecca
IR  - Bara R
FIR - Billian, Elizabeth
IR  - Billian E
FIR - Laptook, Abbot R
IR  - Laptook AR
FIR - Oh, William
IR  - Oh W
FIR - Hensman, Angelita M
IR  - Hensman AM
FIR - Gingras, Dan
IR  - Gingras D
FIR - Francis, Kim
IR  - Francis K
FIR - Andrews, Dawn
IR  - Andrews D
FIR - Angela, Kristen
IR  - Angela K
FIR - Ehrenkranz, Richard A
IR  - Ehrenkranz RA
FIR - Bhandari, Vineet
IR  - Bhandari V
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- 2010/07/01 06:00
MHDA- 2010/07/29 06:00
PMCR- 2011/03/15
CRDT- 2010/07/01 06:00
PHST- 2010/07/01 06:00 [entrez]
PHST- 2010/07/01 06:00 [pubmed]
PHST- 2010/07/29 06:00 [medline]
PHST- 2011/03/15 00:00 [pmc-release]
AID - peds.2009-3353 [pii]
AID - 10.1542/peds.2009-3353 [doi]
PST - ppublish
SO  - Pediatrics. 2010 Jul;126(1):e215-21. doi: 10.1542/peds.2009-3353. Epub 2010 Jun 
      29.