Status:
RECRUITING
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Cloudnine Hospital, Bangalore, India
University of Cincinnati
Conditions:
Late-Onset Neonatal Sepsis
Eligibility:
All Genders
1-3 years
Phase:
NA
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 o...
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 Indir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2026
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04842786
Start Date
May 15 2021
End Date
February 15 2026
Last Update
September 1 2023
Active Locations (2)
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1
Cloudnine Hospital
Bangalore, India
2
Indira Gandhi Institute of Child Health
Bangalore, India