None listed
Conditions
Brief summary
Late-onset sepsis (bloodstream infection) remains one of the most common complications of extremely early birth (more than 3 months before the due date). Skin condition in preterm infants deteriorates quickly after birth and the majority of bloodstream infections are caused by bacteria that reside on the skin. At present there is no available skin care product with proven benefit on skin condition and rates of infection. In this new trial, Neonatal Intensive Care Units of the Australia and New Zealand Neonatal Network will be randomly allocated to either using topical coconut oil or their current standard of skin care for all infants born extremely early to determine if coconut oil may reduce the rate of bloodstream infections. The findings of this trial could be readily translated into clinical practice.
Interventions
Topical coconut oil is the intervention
Eligible infants in neonatal units randomised to the study intervention will receive topical coconut oil starting within 24h from birth. Preterm infants’ skin condition deteriorates rapidly in the first days of life therefore commencement of the intervention within 24h of birth is essential.
• Infants <25 w GA will receive 5ml of coconut oil 4x/day for the first week of life, then 5ml 2x/day until transferred to an open cot.
• Infants >25 w GA will rec
Topical coconut oil is the intervention Eligible infants in neonatal units randomised to the study intervention will receive topical coconut oil starting within 24h from birth. Preterm infants’ skin condition deteriorates rapidly in the first days of life therefore commencement of the intervention within 24h of birth is essential. • Infants <25 w GA will receive 5ml of coconut oil 4x/day for the first week of life, then 5ml 2x/day until transferred to an open cot. • Infants >25 w GA will receive 5ml 2x/day until transferred to an open cot. • Once cared for in an open cot, infants will receive topical coconut oil 1x/day until discharge from the tertiary neonatal unit (to minimise undressing and handling of the infant). Application: - Use a new sachet for each application. - The parents should apply the coconut oil to their infant’s skin if they wish, under supervision of the bedside nurse. - Apply topical coconut oil during routine care to the entire skin (front and back). Do not apply coconut oil to the face, scalp, and sites of vascular access or other devices (e.g. chest drain). - Use only a few gentle strokes to apply coconut oil. Do not massage. Application should only take 1-2 minutes per side. - Discard any unused oil in a sachet after opening. Monitoring Pharmacy stock reports at intervention sites will be compared to the number of eligible infants and expected number of days of treatment will provide an indication of compliance with coconut oil use. Further, monitoring of 20% of eligible infants’ medication charts at the intervention sites, where coconut oil will be prescribed and application signed-off, will be conducted to ensure compliance with the study intervention.
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Hours to 24 Hours
Healthy volunteers
No
Inclusion criteria
Infants born < 28 weeks gestational age
Exclusion criteria
Critically ill infants not expected to survive (as certified by consulting physician) Infants with a primary surgical diagnosis (inability to apply coconut oil to large proportion of skin) Parents do not wish infant to receive coconut oil for skincare
Outcome results
None listed