There is a patent called, "Infant formulas containing long-chain
polyunsaturated fatty acids and uses thereof,"  # 6495599 by Auestad, et al.
and assigned to Abbott Labs filed in March 2001.  The abstract states,
"Methods for providing nutrition and for enhancing neurological development
of preterm infants are disclosed."  In the body of the patent a study is
presented in which 470 perterm infants were enrolled from various NICU's
(Cleveland, USA; Kansas City,USA; Little Rock,USA; London, UK; Louisville,
USA; Portland, USA; New York, USA; and Santiago, Chile.

The following information shocked me:

"5.1 Study Sample

Three-hundred seventy-six (80%) of the 470 infants enrolled completed the
study to 12-months CA. Forty-three infants were classified as EHM feeders
during the early neonatal period based on HM intake until term CA. Of the 144
infants in the control group, 126 (88%) and 91 (63%) remained on study
feeding at term and 12-months CA, respectively. Similarly, of the 140 infants
enrolled in the AA+DHA (fish/fungal) group, 120 (860%) and 89 (64%) remained
on study feeding at term and 12-months CA, and of the 143 infants enrolled in
the AA+DHA (egg-DTG/fish) group, 126 (880/%) and 91 (64%) remained on study
feeding at term and 12-months CA. At term CA, 35%, 28%, and 33% of infants in
the control, AA+DHA (fish/fungal) and AA+DHA (egg-DTG/fish) groups,
respectively, consumed HM at least once per day. By 4months CA, only 14%,
12%, and 12% of infants in the control, AA+DHA (fish/fungal) and AA+DHA
(egg-DTG/fish) groups, respectively, consumed HM. Nineteen (13%), 20 (14%),
11 (8%), and 1 (2%) of infants in the control, AA+DHA (fish/fungal), AA+DHA
(egg-DTG/fish), and EHM groups, respectively, discontinued study feeding due
to symptoms typically associated with feeding intolerance (primary reason for
discontinuation provided by site investigator). 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 groups died. No study deaths were related to study
feeding as judged by the investigator at each site."

No infants in the control group died.  But 6 infants died in the group of 43
infants fed mostly human milk?  Six infants also died in the group of 120
infants that got the (fish/fungal) DHA.  While this study says none of the
deaths were infant formula related, I think that can be a matter of
perspective and dependent on the investigator.

I am not sure how to find out the name of this study and if it was placed in
any journal.  Has anyone seen this study?  It might be a study from Auestad
(the inventor of the patent).  Is anyone doing research on infant formula
studies that I can contact?
For those interested in background information to the DHA and AA controversy,
this patent has many references and one might assume that this is Abbott's
(Ross's) perspective on DHA and AA additive to infant formula.  Go to patent
office http://www.uspto.gov/patft/index.html
click on number (left hand side) and type the patent number #6495599

By the way the infants in the group called EHM (exclusively human milk fed
during early neonatal period) were also getting infant formula.  Stated in
patent, "During the planning phase of this study, it was apparent that most
infants in the participating NICUs were neither exclusively formula-nor
HM-fed, but rather most were fed a combination of formual and HM."  They also
say that, "If HM was fed, it was suggested that it be fortified to 22 to 24
kcal/fl oz and provide a minimum protein intake of 2.8 g/kg/d."  I have alot
of questions about the particular infant formula used to fortify the mostly
human milk fed infants.  My questions are who are the investigators that
determine that infant formula has nothing to do with the deaths?   It seems
to me that 6 deaths to 43 infants is a little high.  The infants were all
under 33 weeks gestational age and with birth weights fo 750-1805 grams
(enrolled from Oct 1996-January 1998).  If anyone recognizes this study,
would they email me.  Thanks.
Valerie W. McClain, IBCLC



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