Chlorhexidine in preterm babies

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12607000050459
• Date of registration: 16/01/2007
• Prospective Registration: No
• Primary sponsor: Sandie Bredemeyer
• Public title: Chlorhexidine in preterm babies
• Scientific title: Use of chlorhexidine as a topical antiseptic for the prevention of nosocomial sepsis in premature neonates < 29 weeks: a blinded randomised controlled trial
• Date of first enrolment: 04/04/2005
• Target sample size: 169
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12607000050459.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;

Countries of recruitment

Australia

Contacts

• Name: Sandie Bredemeyer

• Name: Sandie Bredemeyer

Key inclusion & exclusion criteria

Inclusion criteria: Inborn infants < 29 weeks. Informed parental consent.
Exclusion criteria: Parental consent not given. Ex utero transfer, unlikely to survive major congenital anomaly.

Age minimum: Days
Age maximum: 29 Weeks
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Nosocomial infection in preterm babies;
Nosocomial infection in preterm babies

Reproductive Health and Childbirth - Complications of newborn

Intervention(s)

Aqueous chlorhexidine 0.5% (intervention group) applied topically. The solution is applied prior to each invasive procedure for both control and intervention groups.

Primary Outcome(s)

Number of episodes of nosocomial infection in infants < 29 weeks[During stay in the neonatal intensive care unit (NICU)]

Skin integrity[Before and after application of topical antiseptic]

Secondary Outcome(s)

Developmental outcomes at 12 months corrected age[]

Mortality before discharge from NICU[]

Necrotizing enterocolitis (NEC) at discharge from NICU []

Omphalitis at discharge from NICU []

Osteomyelitis at discharge from NICU[]

Antibiotic days at discharge from NICU []

Length of ventilation at discharge from NICU[]

Length of stay in a tertiary centre[]

Episodes of antibiotic use at discharge from NICU []

Source(s) of Monetary Support

NSW Nurses Midwives Registration Board

Secondary Sponsor(s)

Ester Carman

Nick Evans

Shelley Reid

Ethics review

Status: Not approved
Approval date:
Contact:

Royal Prince Alfred Hospital - RPA Newborn Care Unit