The study protocol was reviewed and
approved by Wayne State University’s Institutional
Review Board. Written informed
consent was obtained from
a parent or legal guardian. Infants were
randomized by a research nurse based
on PMA on day of randomization in
6 permuted blocks (28–33 weeks)
with block sizes of 6 subjects per block
generated by the study biostatistician by
using a computer-generated sequence
provided by Randomization.com (http://
www.randomization.com). The investigators,
physicians, staff nurses, biostatistician,
laboratory research associate,
and parents were blinded and were not
aware of the treatment status of these
infants.