Objective. Most infants with cleft palate suckle unproductively and re
quire feeding by artificial means. Most also have unremitting otitis m
edia accompanied by (usually) nonpurulent middle-ear effusion, a compl
ication generally attributed to impaired eustachian tube ventilatory f
unction. We observed two infants with cleft palate in whom one or both
ears appeared effusion free on more than one occasion, and who also w
ere receiving or previously had received breast milk feedings. This pr
ompted us to analyze the relation between middle-ear status and feedin
g mode in a large series of infants with cleft palate. Our objective w
as to determine whether in these infants the receipt of breast milk mi
tigated the otherwise virtually invariable development and continued p
resence of otitis media. Methods. We reviewed and analyzed data concer
ning both feeding mode and the presence or absence of middle-ear effus
ion in 315 infants with cleft palate, as recorded systematically in th
e course of prospective studies at our Cleft Palate-Craniofacial Cente
r. Analysis was limited to periods preceding the infants' receipt of t
ympanostomy-tube placement or palate repair, or their second birthday,
whichever occurred first. Results. Freedom from effusion in one or bo
th ears was found at one or more visits in only seven (2.7%) of 261 in
fants fed cow's milk or soy formula exclusively, but in 17 (32%) of 54
infants fed breast milk exclusively or in part for varying periods (P
< .0001). In virtually all instances, the breast milk had been harves
ted by the mother and fed to the infant via an artificial feeder. Base
line clinical and sociodemographic characteristics and surveillance in
the two groups of infants were comparable. Conclusions. Artificially
fed breast milk provides variable protection against the development o
f otitis media in infants with cleft palate. This finding supports the
likelihood of a similarly protective effect of breast milk in nonclef
t infants. The finding also suggests strongly that in infants with cle
ft palate, impaired eustachian tube function is not the only pathogene
tic factor in the infants' initial development of middle-ear effusion.