Change in care among nonenrolled patients during and after a randomized trial.
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.
['LeVan|Jaclyn M|JM|', 'Wyckoff|Myra H|MH|', 'Ahn|Chul|C|', 'Heyne|Roy|R|', 'Sánchez|Pablo J|PJ|', 'Chalak|Lina|L|', 'Jaleel|Mambarambath A|MA|', 'Burchfield|P Jeannette|PJ|', 'Christie|Lucy|L|', 'Soll|Roger|R|', 'Badger|Gary J|GJ|', 'Brion|Luc P|LP|']
D015331:Cohort Studies D045422:Continuous Positive Airway Pressure D005260:Female D006801:Humans D007231:Infant, Newborn D007442:Intubation, Intratracheal D005791:Patient Care D018579:Patient Selection D047928:Premature Birth D011663:Pulmonary Surfactants D012127:Respiratory Distress Syndrome, Newborn D013997:Time Factors
unblinded preterm endotracheal intubation process of care birth cohort study non-enrolled patients randomized controlled trial