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Coconut Oil Study

Topical coconut oil application and incidence of sepsis in neonates ââ?¬â?? An Open ââ?¬â?? Label Randomized Controlled Trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/032011
Enrollment
420
Registered
2021-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Coconut oil: Topical application of Coconut oil twice to the body Control Intervention1: Gentle stroking: Control group will receive only gentle stroking over the skin.

Sponsors

Kids Clinic India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Effect of topical coconut oil applicationTimepoint: At Baseline, at 3rd, 7th day, 14th day, 21st day, 28th day of life

Secondary

MeasureTime frame
Neonatal skin integrity Weight gain Intraventricular hemorrhage Necrotizing enterocolitis Retinopathy of prematurity Chronic lung disease MortalityTimepoint: Up to 28 days of life or discharge from NICU whichever is the earliest

Countries

India

Contacts

Public ContactProf Dr Kishore Kumar R

Cloudnine Hospital

drkishore@cloudninecare.com9900155001

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026