Skip to content

Comparison of two different forms of chlorhexidine solution for skin antisepsis in neonates

Efficacy of two different chlorhexidine gluconate preparations for skin antisepsis in neonates: a non inferiority randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019822
Enrollment
850
Registered
2019-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: 1% chlorhexidine gluconate in aqueous form: Routine - Local application to skin Dose- around 0.5 to 1 ml applied to skin and dried Frequency- once per enrollment Duration- once Baby

Sponsors

All India Instiute of Medical Sciences AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) All inborn neonates from 26 0/7 - 42 6/7 weeks of gestation requiring NICU admission for at least 48 hrs 2) All extramural neonates from 26 0/7 - 42 6/7 weeks of gestation requiring admission in PICU/Pediatric surgery ICU/Pediatric HDU/Pediatric emergency irrespective of the duration of stay

Exclusion criteria

Exclusion criteria: 1) Hydrops 2) Generalised skin disorder 3) Skin infection 4) Severe persistent pulmonary hypertension 5) Sick baby requiring high ventilator support as adjudged by the clinical team

Design outcomes

Primary

MeasureTime frame
To compare the proportion of negative post cleansing skin swabs after the skin antisepsis performed by 1% aqueous chlorhexidine gluconate v/s 2 % aqueous chlorhexidine gluconate in neonates 26 0/7-42 6/7 weeks of gestation in first 28 days of lifeTimepoint: post antisepsis skin swab will be taken after 2 minutes of chlorhexidine application

Secondary

MeasureTime frame
Chlorhexidine level estimation in a subset of patientsTimepoint: at 6,12,24-48 hours after chlorhexidine application;To compare local skin reaction to chlorhexidine gluconate applicationTimepoint: At 0,6,12,24 hours after chlorhexidine application

Countries

India

Contacts

Public ContactDr Anu Sachdeva

Division of Neonatology, Department of Pediatrics,AIIMS, New Delhi

dranuthukral@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 15, 2026