Antiseptic efficacy and plasma chlorhexidine levels following two different methods of application of 1 % aqueous chlorhexidine gluconate for skin disinfection in preterm newborns: A blinded, parallel group, randomized trial

Study plan: This is a randomized control trial to compare two different methods of application of 1 % aqueous CHG for local skin disinfection in preterm neonates, in terms of antiseptic efficacy and systemic absorption of chlorhexidine.

There is no consensus as to which agent should be used for local skin antisepsis in neonates. Currently povidone iodine and alcohol swabs are being used in many units in India but they can cause hypothyroidism and skin burns respectively. Thus, in this subgroup of preterm neonates 1 % aqueous chlorhexidine is an effective alternative as per available evidence. But, it has been seen that even with 1 % solution of chlorhexidine gluconate there can be systemic absorption and a safe upper limit of plasma chlorhexidine is not yet known.

Our aim is to find a way to reduce this systemic absorption as far as possible, by seeing if application of chlorhexidine followed by wiping with sterile water swab decreases this systemic absorption of chlorhexidine compared to the standard method of air drying the antiseptic agent after application, without decreasing its antiseptic efficacy.

This will be a superiority trial (by margin of 50 %) for reduction in plasma chlorhexidine levels and a non inferiority trial (by a margin of 5 %) for antisepsis efficacy.

Sample size for seeing if the intervention reduced plasma chlorhexidine levels is 90 and that for proving its non inferiority in terms of antisepsis efficacy is 560.

Current status: The study was completed in July 2022. A total of 457 enrollments were done in 229 neonates. Cleansing was not found to be non-inferior to the standard method in terms of skin anti-sepsis. Plasma chlorhexidine levels were not found to be different significantly between both groups.