A clinical study to understand if a new method of application of 1 % chlorhexidine solution for skin cleaning in newborn babies would result in lower blood levels of chlorhexidine without decreasing its antiseptic property when compared to the standard method of applying it.

Completed

• Conditions: Certain conditions originating in the perinatal period,

• Registration Number: CTRI/2020/10/028719
• Lead Sponsor: Department of Pediatrics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-11
• Study Completion: 2022-07-31
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

1. All neonates born inside at 28 0/7 to 34 6/7 weeks GA ,at least 48 hours of age & before 2 weeks post natal age 2) All neonates born outside at 28 0/7 to 34 6/7 weeks GA, at admission to NICU and pediatric surgical ICU & before 2 weeks post natal age.

Exclusion Criteria

Disorders of skin Local skin infection Hydrops.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Plasma chlorhexidine level (ng/mL) determined by HPLC/MS	1) 12 hours post exposure for plasma chlorhexidine levels | 2) Just before and after application of 1 % aqueous Chlorhexidine in any of the above two methods for skin swab collection
2)Proportion of negative post antisepsis skin swabs (≤15 CFU/mL)	1) 12 hours post exposure for plasma chlorhexidine levels | 2) Just before and after application of 1 % aqueous Chlorhexidine in any of the above two methods for skin swab collection

Secondary Outcome Measures

Name	Time	Method
Local skin reaction by visual inspection and dermatitis scoring	0(±1), 6(±1), 12(±1) hours post exposure

Trial Locations

Locations (1)

AIIMS NEW DELHI; 🇮🇳 Delhi, DELHI, India

AIIMS NEW DELHI

🇮🇳Delhi, DELHI, India

RICHIE DALAI

Principal investigator

9914842233

richie.aiims@gmail.com