Coconut Oil Study
Phase 2
- Registration Number
- CTRI/2021/03/032011
- Lead Sponsor
- Kids Clinic India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Premature infants 24-36 weeks GA
Full-term infants 37-42 weeks GA
Less than 48 hours of age at enrollment
Admitted to the NICUs of Indira Gandhi Institute for Child Health, Cloudnine Hospital at Old Airport Road and Cloudnine Hospital at Jayangar, Bangalore
Expected to be in the NICU 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of topical coconut oil applicationTimepoint: At Baseline, at 3rd, 7th day, 14th day, 21st day, 28th day of life
- Secondary Outcome Measures
Name Time Method eonatal skin integrity <br/ ><br>Weight gain <br/ ><br>Intraventricular hemorrhage <br/ ><br>Necrotizing enterocolitis <br/ ><br>Retinopathy of prematurity <br/ ><br>Chronic lung disease <br/ ><br>MortalityTimepoint: Up to 28 days of life or discharge from NICU whichever is the earliest