Topical Coconut Oil Application and Incidence of Sepsis in Neonates

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Late-Onset Neonatal Sepsis

Treatments: Other: Coconut oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04842786

2020-0487 (Other Identifier)

Details and patient eligibility

About

The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.

Full description

Purpose and Specific Aims

The purpose is to determine the effect of twice daily topical coconut oil application on late onset sepsis in neonates admitted to the Neonatal Intensive Care Units of Indira Gandhi Institute of Child Health, Cloudnine Hospital at Old Airport Road, and Cloudnine Hospital at Jayanagar in Bangalore, India. The aim is to determine the effect of topical coconut oil application on:

• The incidence of neonatal late onset culture positive sepsis
• Neonatal skin integrity versus a no treatment control using standard skin evaluation methods
• Biomarkers of neonatal innate immune function
• Temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality.

The investigators hypothesize that twice daily topical coconut oil application will reduce the incidence of late onset sepsis (LOS) in premature and full-term infants versus the current standard of care, i.e., no treatment. The oil treatment will increase the neonatal skin barrier integrity measured by validated clinical and instrumental methods. Skin surface biomarkers of innate immune function collected from coconut oil treated skin will indicate less inflammation (lower proinflammatory cytokine levels) than in untreated control skin.

Enrollment: 420 estimated patients

Sex: All

Ages: 1 to 3 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

420 participants in 2 patient groups

Coconut oil at 5 mg/Kg body weight twice daily

Experimental group

Description:

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.

Treatment:

Other: Coconut oil

No intervention

No Intervention group

Description:

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.