A pilot study to understand the best way of applying antiseptic, with or without sunflower oil, to low birth weight newborn babies who are in hospital

Efficacy and safety of whole-body chlorhexidine gluconate (CHG) cleansing in reducing bacterial skin colonisation of hospitalised neonates: A pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN69836999

Enrollment

182

Registered

2020-06-18

Start date

2021-04-12

Completion date

Unknown

Last updated

2024-03-11

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

Conditions

Low birth weight (1-2kg) babies Neonatal Diseases

Interventions

Chlorhexidine gluconate (CHG) whole body skin application in varying concentrations (2% vs 1% vs 0.5%) and varying frequency, each with or without emollient application, compared to a control group wi

or Tuesday, Thursday, Saturday, depending on the standard working pattern in each country.)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 1-6 days (post-natally) at enrolment 2. Gestational age =28 weeks at birth 3. Birth weight =1000g and <2000g (or current weight if unknown) 4. Parental consent 5. Parent’s willingness to avoid routine use of emollients other than those indicated by the randomised allocation

Exclusion criteria

Exclusion criteria: 1. Poor skin condition (skin score of 2 or more in any of three domains) at the time of enrolment 2. Known congenital or acquired skin disorder or defect at time of enrolment 3. Anticipated length of hospital stay <7 days 4. Chlorhexidine or emollient application determined inappropriate in the opinion of the enrolling clinician

Design outcomes

Primary

Measure	Time frame
Individual follow up during hospital admission up to day 14 after enrolment or discharge if earlier, and final follow up 28 days after enrolment (by phone If already discharged). 1. Skin bacterial load – change in colony forming units (CFUs) in the nose (1 swab), cervical skin folds and umbilicus (1 pooled swab), and peri-rectal area (1 swab) from randomisation (before chlorhexidine application) to D3+/- 1 day and D8 +/- 3 days microbiology data collection (efficacy). 2. Modified neonatal skin condition score used before each application of chlorhexidine, or alternate working days in controls (safety). The primary analysis of this outcome will consider the absolute score. Secondary analysis of this outcome will consider graded toxicity.	—

Measure

Time frame

Individual follow up during hospital admission up to day 14 after enrolment or discharge if earlier, and final follow up 28 days after enrolment (by phone If already discharged). 1. Skin bacterial load – change in colony forming units (CFUs) in the nose (1 swab), cervical skin folds and umbilicus (1 pooled swab), and peri-rectal area (1 swab) from randomisation (before chlorhexidine application) to D3+/- 1 day and D8 +/- 3 days microbiology data collection (efficacy). 2. Modified neonatal skin condition score used before each application of chlorhexidine, or alternate working days in controls (safety). The primary analysis of this outcome will consider the absolute score. Secondary analysis of this outcome will consider graded toxicity.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Bangladesh, South Africa

Contacts

Public ContactMike Sharland

mrcctu.neochg@ucl.ac.uk+44 (0)208 725 5382

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026