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Infants were randomized according to a computer-generated random number table with random block sizes.
Study design In a randomized, double-blind trial, previously well infants were randomized upon discharge from the emergency department to receive either albuterol (0.1 mg/kg/dose) three times per day or placebo three times per day for 7 days.
Infants were randomized to groups before delivery.
Results: A total of 149 infants were randomized; 50 were allocated to receive racemic EPI, 51 were given ALB, and 48 received PLAC.
Four infants were randomized to iNO and four to O2 (controls).
In trial 1, LBW infants were randomized to receive an early BCG vaccine or the usual delayed BCG vaccine.
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If the infant is randomized to the KMC condition, the research nurse will begin by recording a one-minute sample of the infant in the incubator.
These data were analyzed using a new method (multiple outputation) to account for potential confounding effects of enrolling infants from multiple gestations, of whom only the first eligible infant was randomized.
The MITT analysis differed from a strict intention-to-treat (ITT) population because it excluded infants who were randomized but never vaccinated since these infants were not followed for efficacy outcomes.
Four infants each were randomized to iNO or O2 (controls).
LBW infants who were randomized to not receiving early BCG vaccination were not included in the present study since we aimed to look at the effect of OPV on the immune response to BCG given at the same time.
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