Randomised controlled trial of brief neonatal exposure to cows' milk on the development of atopy.
OBJECTIVE
To determine the effect of brief early exposure to cows' milk on atopy in the first 2 years of life.


METHODS
Double blind, placebo controlled, randomised feeding intervention trial (Bokaal study).


METHODS
Dutch midwifery practices.


METHODS
1533 breast fed neonates.


METHODS
Exposure to cows' milk protein (n = 758) or a protein free placebo (n = 775) during the first 3 days of life.


METHODS
Clinical atopic disease and any positive radioallergosorbent (RAST) tests at 1 year of age.


RESULTS
Atopic 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.


CONCLUSIONS
Early and brief exposure to cows' milk in breast fed children does not increase the risk of atopic disease in the first 2 years.
de Jong
M H
MH
Department of Paediatrics, Emma Children's Hospital, Academic Medical Center (AMC), University of Amsterdam, Netherlands.
Scharp-van der Linden
V T
VT
Aalberse
R C
RC
Oosting
J
J
Tijssen
J G
JG
de Groot
C J
CJ
D000818:Animals; D001942:Breast Feeding; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000209:etiology*; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D008297:Male; D008892:Milk / Q000009:adverse effects*; D011852:Radioallergosorbent Test; D012307:Risk Factors