None listed
Conditions
Brief summary
Project’s aim(s): We aim to assess the safety and efficacy of topical application of coconut oil in improving skin integrity in very preterm infants (<30 weeks) Justification: The skin of a premature baby is delicate. Loss of body water through the thin skin can cause dehydration, weight loss, dry skin and increased risk of infections. The skin care of premature babies includes minimal handling, humidification in the incubator, and topical application of creams and various natural oils. Studies have shown that topical application of creams increase the risk of infections. Studies from developing countries have shown that topical application of natural oils improves skin condition, causes weight gain, and reduces the risk of infection in preterm infants. Also, Coconut oil has large amount of fats with antibacterial properties. None of these studies reported any significant side effects of topical application of coconut oil. However these trials did not involve enough number of very premature babies. Considering that it is a simple and inexpensive option. We plan to conduct a study of topical application of coconut oil for improving skin condition of very premature babies born before 30 weeks. Participant group(s): Participants will be the preterm infants <30 weeks (Coconut oil+ standard treatment {minimal handling, high humidity}-36, Standard treatment-36) Project design and methods: This study will be a randomized controlled trial. The baby’s skin will be assessed by a trained nurse (using the routine protocol for skin assessment in hospital ) within 24 hours of admission and then on day 7, 14 and 21 after birth. Coconut oil will be applied (starting within 24 hours of admission in nursery) to the baby’s skin using gentle strokes without excessive pressure and avoiding massage. The application will not cover the face, head and drip site .Oil will be provided in separate tubes for each baby and the left over will be discarded after each application, to minimize the risk of infection. We will collect information about the progress of the baby (nutritional parameters and impact on various complications of prematurity). Skin surface swabs (from ear lobes, axilla and groin) would be taken weekly to monitor the change in bacterial flora on the skin. weekly weight gain per kg body weight during the study intervention and until discharge or death after first admission. Two blood samples of 500 microlitre each for assessment of plasma Lauric acid and Monolaurin levels will be taken from the infants veins prior to study intervention and after 10 days(within 72 hours of collection).Whenever possible, blood sampling will be combined with sampling for routine blood tests. No more than 2 attempts at blood collection will be performed. Expected outcomes: Based on our hypothesis we expect that coconut oil application in very preterm babies will be safe and would result in improvement in their skin condition and reduce the incidence of infections.
Interventions
Virgin coconut oil will be sourced from a single supplier in 50 ml aliquots and will be distributed to each participant in individual containers twice weekly to avoid cross contamination . This product is certified organic, rich in lauric acid (~50%) and has been independently tested for lack of contamination with pesticides and absence of microbial growth.
The oil application (5 ml/kg per application, 12 hourly for 3 weeks) by trained nursing staff will commence within 24 hours of admission to
Virgin coconut oil will be sourced from a single supplier in 50 ml aliquots and will be distributed to each participant in individual containers twice weekly to avoid cross contamination . This product is certified organic, rich in lauric acid (~50%) and has been independently tested for lack of contamination with pesticides and absence of microbial growth. The oil application (5 ml/kg per application, 12 hourly for 3 weeks) by trained nursing staff will commence within 24 hours of admission to provide optimal potential benefit. Strict hand hygiene protocol will be followed. Each application will be completed in 2-3 minutes, involving gentle strokes without massage. To avoid excessive handling, oil application will be timed with routine care procedures. The oil application will involve 4 steps. Infant in supine position: (1) Apply to front of the trunk starting from level of clavicles down to the groins. (2) Apply to the thighs, knees and feet. (3) Apply to upper limbs starting from the shoulder blades along the posterior of the arms to the back of the hands, and then going back to the shoulders covering the opposite side of the arms. Prone position: (4) Apply starting from the neck to above the nappy area, extending laterally to the flanks and then apply to the back of the lower limbs to the foot. Avoid the scalp, face and intravenous infusion sites.The patients in intervention arm will recieve standard routine care given in the nursery in addition to coconut oil application.Each oil application in intervention arm will be logged in to patients medical charts by the nursing staff to moniter adherance.
Sponsors
King Edward Memorial Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Hours to 24 Hours
Healthy volunteers
No
Inclusion criteria
(1) Gestation <30 weeks, (2) Postnatal age <24 hours, (3) Informed parental consent
Exclusion criteria
(1) Presence of major congenital malformation/s requiring surgery, (2) Congenital skin abnormality or signs of skin infection, (3) life-threatening illness during the first 24h of life (as certified by the consulting physician)
Outcome results
None listed