Comparison between two ocular cleansing modalities in a population of newborns admitted to Neonatal Intensive Care Unit with clinical signs of conjunctivitis: a randomized controlled trial.

Background: Neonatal conjunctivitis is frequent and could benefit from daily cleansing with saline. Anyway super infections can occur and therefore antibiotics are frequently needed. Recently alternative therapies (e.g. Echinacea angustifolia) are used for neonatal conjunctivitis to try to reduce antibiotics therapy. The aim of the study was to verify if the use of gauze containing Echinacea angustifolia compared to standard sodium-chloride at the onset of conjunctivitis symptoms is effective in reducing the clinical symptoms and the risk for superinfections.

Methods: The study was randomized and controlled. Neonates admitted in a tertiary level Neonatal Intensive Care Unit (NICU), with clinical signs of conjunctivitis during hospital stay, were randomized in two groups: group A (3 times daily ocular cleansing for 48 h with sterile gauze; group B (3 times daily ocular cleansing for 48 h with Iridium® baby gauze (Neoox) containing Echinacea angustifolia and pineapple sativus). An eye swab for cultural analysis was taken at time of presentation (T0) prior to treatment and at the end of ocular cleansing (T1).

Results: Sixty-three neonates were enrolled (GrA=30 and GrB=33). At T0, eye specimen positivity was found in 16/30 (48%) in group A and in 18/33 (55%) in group B (P=0.9). No statistical differences among groups at T0 regarding culture positivity. After 48 h, babies in Gr A have significantly fewer positive swabs compared to group B (group A: 18/29, group B: 10/32; P=0.009). Neonates in group B who had negative swab at T0 had a significantly reduced risk to have positive culture at T1 (OR 0.28, CI: 0.10-0,80, P=0.01), also considering confounding factors (birth weight, gestational age, mode of delivery) (adjusted OR 0.15, CI: 0.03-0.52, P<0.01). No differences in regard to antibiotic needs (P=0.95) during the course of conjunctivitis between groups.

Conclusions: Our data suggest that these gauzes containing Echinacea angustifolia might help in avoiding super-infections, contaminations and in reducing ocular bacterial load.