Background and Aims Food hypersensitivity is a common cause of digestive symptoms in neonates. To confirm the diagnosis of neonatal cow’s milk allergy (CMA), an oral food challenge (OFC) test should be conducted. However, many neonatologists in Japan avoid OFC because of excessive anxiety regarding induction of severe symptoms and continue to feed babies therapeutic formula without an accurate diagnosis. We conducted a prospective multicenter survey in which the standardized OFC was required in neonates with mild symptoms suggesting CMA.
Methods Neonates presenting with digestive symptoms suggesting CMA and who underwent OFC were enrolled between April 2010 and September 2011. Neonates with severe complications, inborn disorders or severe symptoms at the onset, such as anaphylaxis, mass gastrointestinal bleeding, or perforation, were excluded. This study was conducted as a multicenter survey of major NICUs in Japan.
Results OFC was performed in 52 neonates and positive inductions of symptoms were seen in 23 (44%) of the challenged neonates. The majority had mild digestive symptoms which disappeared immediately after elimination of the causal milk. According to the results of OFC, the sensitivity, specificity, and positive predictive value of milk-specific IgE were 0%, 93%, and 0%, and those of the allergen-specific lymphocyte stimulation test were 61%, 76%, and 67%, respectively.
Conclusions Diagnostic OFCs for CMA were safely carried out in neonates. The discontinuation of certain foods as part of an elimination diet can lead to appropriate nutrition management. In NICUs, OFC should be carried out more aggressively with careful observation.