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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028719
Enrollment
560
Registered
2020-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P00-P96- Certain conditions originating in the perinatal period

Interventions

Intervention1: Wiping off 1 % chlorhexidine with sterile water swab post application: Sequential application of 1 % aqueous chlorhexidine for skin antisepsis in preterm neonates 28-34 weeks gestation

Sponsors

Department of Pediatrics
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Disorders of skin Local skin infection Hydrops

Design outcomes

Primary

MeasureTime frame
1) Plasma chlorhexidine level (ng/mL) determined by HPLC/MS 2)Proportion of negative post antisepsis skin swabs (=15 CFU/mL) Timepoint: 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

MeasureTime frame
Local skin reaction by visual inspection and dermatitis scoringTimepoint: 0(±1), 6(±1), 12(±1) hours post exposure—

Countries

India

Contacts

Public ContactRAMESH AGARWAL

AIIMS NEW DELHI

ra.aiims@gmail.com9810756718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026