PMID- 24043277
OWN - NLM
STAT- MEDLINE
DCOM- 20131129
LR  - 20140902
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Linking)
VI  - 132
IP  - 4
DP  - 2013 Oct
TI  - Change in care among nonenrolled patients during and after a randomized trial.
PG  - e960-70
LID - 10.1542/peds.2013-1595 [doi]
AB  - OBJECTIVE: Parkland Memorial Hospital (PMH) participated in Surfactant, Positive 
      Pressure, and Oxygenation Randomized Trial (SUPPORT), an unblinded controlled 
      trial, in which preterm neonates of 24(0/7) to 27(6/7) weeks' gestational age 
      (GA) were randomized in the delivery room (DR) to endotracheal intubation or 
      nasal continuous positive airway pressure. We hypothesized that DR intubation 
      could change in nonenrolled patients at PMH and that the change would be larger 
      than in comparable centers not participating in the trial. METHODS: The PMH 
      Cohort included eligible but nonenrolled neonates of 24(0/7) to 27(6/7) weeks 
      (primary) and noneligible neonates of 28 to 34(6/7) weeks (confirmatory). A 
      subset (24(0/7)-29(6/7)weeks) of that cohort was compared with a contemporaneous 
      cohort born in centers participating in the Vermont Oxford Network (VON). We used 
      a Poisson regression model to obtain adjusted relative risks (RRs) of DR 
      intubation (during/after SUPPORT versus before SUPPORT) for PMH and for VON along 
      with the ratio of these RRs. RESULTS: In the PMH cohort (n = 3527), the 
      proportion of DR intubation decreased during/after SUPPORT in the lower GA group 
      (adjusted RR 0.76, 95% confidence interval [CI] 0.59-0.96) and the upper GA group 
      (adjusted RR 0.57, 95% CI 0.46-0.70). Compared with the RR for DR intubation in 
      VON, the RR at PMH was smaller in the lower (ratio of RR 0.76, 95% CI 0.65-0.87) 
      and the upper GA group (ratio of RR 0.52, 95% CI 0.39-0.68). CONCLUSIONS: A 
      center's participation in an unblinded randomized trial may affect process of 
      care of nonenrolled patients.
FAU - LeVan, Jaclyn M
AU  - LeVan JM
AD  - The University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd, STOP 
      9063, Dallas, TX 75390-9063. luc.brion@utsouthwestern.edu.
FAU - Wyckoff, Myra H
AU  - Wyckoff MH
FAU - Ahn, Chul
AU  - Ahn C
FAU - Heyne, Roy
AU  - Heyne R
FAU - Sanchez, Pablo J
AU  - Sanchez PJ
FAU - Chalak, Lina
AU  - Chalak L
FAU - Jaleel, Mambarambath A
AU  - Jaleel MA
FAU - Burchfield, P Jeannette
AU  - Burchfield PJ
FAU - Christie, Lucy
AU  - Christie L
FAU - Soll, Roger
AU  - Soll R
FAU - Badger, Gary J
AU  - Badger GJ
FAU - Brion, Luc P
AU  - Brion LP
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20130916
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Pulmonary Surfactants)
SB  - IM
CIN - Arch Argent Pediatr. 2014 Jun;112(3):e118-9. PMID: 25181758
MH  - Cohort Studies
MH  - Continuous Positive Airway Pressure/methods/trends
MH  - Female
MH  - Humans
MH  - Infant, Newborn
MH  - Intubation, Intratracheal/methods/trends
MH  - Patient Care/methods/*trends
MH  - *Patient Selection
MH  - Premature Birth/diagnosis/epidemiology/*therapy
MH  - Pulmonary Surfactants/therapeutic use
MH  - Respiratory Distress Syndrome, Newborn/diagnosis/epidemiology/therapy
MH  - Time Factors
OTO - NOTNLM
OT  - birth cohort study
OT  - endotracheal intubation
OT  - non-enrolled patients
OT  - preterm
OT  - process of care
OT  - randomized controlled trial
OT  - unblinded
EDAT- 2013/09/18 06:00
MHDA- 2013/12/16 06:00
CRDT- 2013/09/18 06:00
PHST- 2013/09/18 06:00 [entrez]
PHST- 2013/09/18 06:00 [pubmed]
PHST- 2013/12/16 06:00 [medline]
AID - peds.2013-1595 [pii]
AID - 10.1542/peds.2013-1595 [doi]
PST - ppublish
SO  - Pediatrics. 2013 Oct;132(4):e960-70. doi: 10.1542/peds.2013-1595. Epub 2013 Sep 
      16.