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

Not Applicable

Completed

• Conditions: ow birth weight (1-2kg) babies; Neonatal Diseases

• Registration Number: ISRCTN69836999
• Lead Sponsor: St George's, University of London

Brief Summary

2023 Abstract results in https://escmid.reg.key4events.com/AbstractList.aspx?e=17&preview=1&aig=-1&ai=13126 Presented at ECCMID (added 18/04/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38426071/ (added 01/03/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-18
• Study Completion: 2022-02-15
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 208

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>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). <br>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 Outcome Measures

Name	Time	Method
There are no secondary outcome measures