Chris,
When I first read the patent I thought like you do, that it was stating that
no infants died in the EHM group and 6 in the control group.  It is what
makes sense to me.  As you point out, the sentence is confusing.  The problem
with this patent and its information is that they have at least 6 tables of
information but this rather important information is not in any of the tables
even the one that shows clinical problems (NEC, systemic infections, lung
disease).  When I reread the sentence, I found myself wondering about the
comma after control rather than infants and ending with "EHM died."

"During the course of the study, 6,3,6 and 0 infants in the control, AA+DHA
(fish/fungal), AA+DHA(egg-DTG/fish) and EHM died."

Why place it that way?  It would seem for a matter of clarity one would state
no infants died in the EHM group, 6 in the control group, 3 in the DHA/AA
(fish/fungal) group, 6 in the DHA/AA (egg/fish) group.

According to this patent, "Following informed written consent from at least
one parent or guardian, infants were randomized to one of three study formula
groups with or without the added long chain polyunsaturated fatty acids, AA
and DHA; 1) control 2) AA+DHA (fish/fungal) and 3) AA+DHA (egg-DTG/fish).
The day of first enteral feeding under this study is considered Study Day
(SDAY) 1.  The computer-generated randomization schedule was blocked for
site, gender, and birth weight stratum (750-1250g and 1251-1800g) using a
permuted blocks algorithm.  After randomization, subjects were fed HM and/or
the assigned in-hospital Type 1 preterm formula...."

One would assume by the above statements about randomization that the EHM
were randomized to on of the three groups--meaning they weren't truly a
separate group.  But I am not sure about that either.  It is why I would be
very interested to find this study, if it was published in a journal.  So I
am hoping that anyone who has run across this particular study will email me.
 Chris, thanks for your comments.  I agree that the issue is clouded because
all the babies were "mixed" fed (human milk and formulas) rather than
exclusively fed one thing or another.
Valerie W. McClain, IBCLC

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