Randomised controlled trial of brief neonatal exposure to cows' milk on the development of atopy
a Department of
Paediatrics, Emma Children's Hospital, Academic Medical Center (AMC),
University of Amsterdam, PO Box 22700, 1100 DE Amsterdam, Netherlands, b Department of Clinical
Epidemiology and Biostatistics, Academic Medical Center, University of
Amsterdam, c Central Laboratory of the Netherlands Blood
Transfusion Service, Amsterdam, Netherlands
Correspondence to: Dr de Jong.
Accepted 9 March 1998
OBJECTIVE
To determine
the effect of brief early exposure to cows' milk on atopy in the first
2 years of life.
DESIGNDouble blind,
placebo controlled, randomised feeding intervention trial (Bokaal study).
SETTINGDutch
midwifery practices.
PARTICIPANTS1533
breast fed neonates.
INTERVENTIONExposure
to cows' milk protein (n = 758) or a protein free placebo
(n = 775) during the first 3 days of life.
MAIN OUTCOME
MEASURESClinical atopic disease and any positive
radioallergosorbent (RAST) tests at 1 year of age.
RESULTSAtopic disease
in the first year was found in 10.0% (cows' milk)
v 9.3% (placebo) of the children, with a
relative risk of 1.07; in the second year, atopic disease was found in
9.6% v 10.2%, respectively, with a
relative risk of 0.94. Per protocol analysis showed similar results.
Any RAST positive test was found in 9.4% (cows' milk)
v 7.9% (placebo) of children, with a
relative risk of 1.19. Stratified analysis for high family risk of
allergy showed a doubled incidence of atopic disease but no effect from
the intervention.
CONCLUSIONEarly and
brief exposure to cows' milk in breast fed children does not increase
the risk of atopic disease in the first 2 years.
© 1998 by Archives of Disease in Childhood
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