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Topical oil for skin protection in neonates

Assessing the impact of topical sesame oil application on skin barrier function in neonates: A pilot randomised controlled trial in Pune, India

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023963
Enrollment
60
Registered
2020-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Topical application of Sesame oil treated with herb Sida Cordifolia (Bala Tailam): Sesame oil application to the neonates will be done by study nurses within two hours of birth after th

Sponsors

Dr D Y Patil University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All neonates born at the delivery unit of the study hospital will be eligible for this study except for the defined exclusions

Exclusion criteria

Exclusion criteria: 1) Age > 2 hours since birth 2)Birth weight below 1000 grams 3)Referral to other department for any surgical/emergency conditions such as necrotising enterocolitis, haemodynamically unstable infants 4)Skin conditions: Clinically evident skin infection or generalized skin disease likely to produce a defect in epidermal barrier function (e.g.ichthyosis), and any structural defect of the skin involving over 5% body surface area (e.g., congenital blistering disorder) 5) Births by Caesarean Section

Design outcomes

Primary

MeasureTime frame
The primary outcome is reduction in Trans Epidermal Water Loss (TEWL).Timepoint: Trans Epidermal Water Loss (TEWL)will be measured twice daily-12 hrly, untill 7 days or discharge if earlier.

Secondary

MeasureTime frame
The trend in change in bacterial colonization at axillary,periumbilical and groin sites measured in log CFU/ml after intervention compared to baseline levels will be the secondary outcome.Timepoint: Two hours after oil application, At 24 hours, At 48 hours

Countries

India

Contacts

Public ContactSarika Chaturvedi

Dr D Y Patil University

sarika.chaturvedi@dpu.edu.in912027805000

Outcome results

None listed

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