The objective of this study was to compare the safety and efficacy of the H
eat Moisture Exchange (HME) device with conventional humidification in neon
ates. Sixtyfour neonates were randomized at intubation to receive conventio
nal humidification (CH) (n = 34) or HME, via a Neoaid device (n = 30). Grou
ps were compared for intrinsic characteristics and outcome variables. Data
were assumed nonparametric and analyzed by Mann-Whitney and Fisher's Exact
test. No significant differences were found in group characteristics or out
come variables. Trends were noted for documented patent ductus arteriosus (
PDA), endotracheal tube blockage, and positive endotracheal aspirate cultur
e. Rate of pneumothorax 2/34 (CH) versus 4/30 (HME) (p = 0.4); rate of tube
blockage 3/34 (CH) versus 2/30 (HME) (p = 1.0); rate of PDA 8/34 (CH) vers
us 14/30 (HME) (p = 0.093) and rate of endotracheal colonisation 17/34 (CH)
versus 9/30 (HME) (p = 0.17). No significant difference was found for dura
tion of ventilation or period in greater than 40% oxygen between the two gr
oups. There were no significant outcome differences between CH and HME. The
HME device was cost-effective and simple to use. A larger multicenter tria
l is warranted to confirm the efficacy of HME.