Clinical trial NCT04842786: Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Official title: Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Late-Onset Neonatal Sepsis
Keywords: 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
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Cloudnine Hospital, Bangalore, India
name: University of Cincinnati
First posted: 2021-04-13
Enrollment: 420
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-blind, parallel group, controlled trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Late-onset sepsis rate for intervention versus control
timeFrame: Day 3 of life until discharge or day of life 28, whichever occurs first
Secondary outcomes:
measure: Skin erythema
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Skin rash
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Skin dryness
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Skin transepidermal water loss
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Skin surface acidity (pH)
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Set of skin surface proteins of known innate immune function
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Skin Microbiome
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Chronic lung disease
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Causative Organisms of Sepsis
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first
measure: Necrotizing enterocolitis
timeFrame: Day 3 of life until discharge or day of life 28, whichever comes first.
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Cloudnine Hospital
city: Bangalore
country: India
facility: Indira Gandhi Institute of Child Health
Study officials:
affiliation: Cloudnine Hospital
name: Kishore Kumar, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indira Gandhi Institute of Child Health
name: Naveen Benakappa, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indira Gandhi Institute of Child Health
name: Prathik B H, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: