Background Cholestasis is one of the most frequent diagnoses in paediatric hepatology. During the past years progress was made in molecular genetics leading to an accurate diagnosis of diseases previously considered idiopathic. In Romania, a great part of cholestatic diseases remain aetiologically unexplained.

Objective To establish the aetiology and to analyse the particularities of evolution of cholestasis in neonates and infants.

Methods We retrospectively studied patients with cholestasis followed up during a 2-year period in a university paediatric hospital, analysing the aetiology, the presence of jaundice, the liver tests and the response to ursodeoxycholic acid in neonates and infants.

Results We have studied 21 neonates (13.82%) and 42 infants (27.64%) with cholestasis. In neonates the most frequent were idiopathic neonatal hepatitis (11 patients, 52.38%) and cytomegalovirus infection in five patients (23.81%). Biliary atresia was diagnosed in only one patient (4.77%). In infants the most frequent were cytomegalovirus infection in 17 patients (40.48%), idiopathic neonatal hepatitis in 11 patients (26.19%), biliary atresia and chronic hepatitis B in three cases (7.15%). In 66.67% of neonates jaundice was present, compared with 33.34% in infants. Ursodeoxycholic acid was used in 27 infants, 88.89% of these patients had a good evolution of cholestasis, with a mean period of 3.12 months until normalisation of the γGT level.

Conclusions Most frequently in our country, the aetiology of cholestasis remains idiopathic neonatal hepatitis and cytomegalovirus infection. The frequency of jaundice associated with cholestasis is decreasing with the increase in age.