Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Late-Onset Neonatal Sepsis
About this trial
This is an interventional prevention trial for Late-Onset Neonatal Sepsis focused on measuring late-onset neonatal sepsis, premature infant, full-term infant, skin, skin barrier, biomarker, stratum corneum, skin surface acidity (pH), transepidermal water loss, imaging, d'squame tape, microbiome, coconut oil
Eligibility Criteria
Inclusion Criteria:
- Premature infants 24-36 weeks gestational age
- Full-term infants 37-42 weeks gestational age
- Less than 48 hours of age at enrollment
- Admitted to the neonatal intensive care unit of Indira Gandhi Institute for Child Health, Cloudnine Hospital at Old Airport Road and Cloudnine Hospital at Jayangar, Bangalore
- Expected to be in the neonatal intensive care unit for at least 4 days after enrollment
- Able to tolerate study procedures as described
- Parent/guardian willing to provide written informed consent
Exclusion Criteria:
- Medically unstable
- Parent/guardian unable to provide written informed consent
- Presence of inherited cutaneous condition e.g., scalded skin syndrome, epidermolysis bullosa
- Presence of major congenital anomalies
- Infants undergoing surgery
Sites / Locations
- Cloudnine HospitalRecruiting
- Indira Gandhi Institute of Child Health
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Coconut oil at 5 mg/Kg body weight twice daily
No intervention
Coconut oil (Parachute Brand) is a marketed product that is routinely used for daily massage after birth for infants in India. An amount of 5 mg/Kg body weight will be applied twice daily by the health care provider from enrollment until discharge, or until day of life 28, whichever occurs first.
Subjects assigned to this arm will have their skin gently stroked twice daily for the time that would be required to apply an oil. This will simulate the stroking received by the intervention arm subjects. This will occur from enrollment until discharge, or until day of life 28, whichever occurs first.