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Skin Antiseptics in Newborn- Pilot study

Comparison of Safety & Efficacy of Five Skinantiseptics in Newborns

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/10/010077
Enrollment
250
Registered
2017-10-12
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

Health Condition 1: null- Term Newborns after 24hours of life till 28 days of life needing venous access

Interventions

None listed

Sponsors

Dr Madhu B Jagalasar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Any neonate with post natal age from > 24 hours to 2.Need for venipuncture for any medical indication

Exclusion criteria

Exclusion criteria: 1.Birth weight 2.Neonates with major congenital anomalies 3.Pre-existing skin disorders like vesico-bullous lesions, skin exfoliation and erythema 4.Previous documentation of skin reactions to antiseptics 5.Significant hemodynamic instability

Design outcomes

Primary

MeasureTime frame
Bacterial colony count as assessed by pre & post cleansing skin swab culture.Timepoint: 6 months

Secondary

MeasureTime frame
1.AWHONN Skin condition score -Immediate or late skin reactions will be recorded. 2.Skin pH will be recorded before and after skin antiseptic use. 3.Stratum corneum hydration will be recorded before and after antiseptic use. 4.Serum chlorhexidine levels will be checked in babies in whom chlorhexidine andchlorhexidine alcohol combination antiseptics will be used. Sreum thyroid levels will be checked in this babies in whom poisone iodine would be used before discharge.Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Madhu B Jagalasar

Chettinad Hospital & Research Institute

giridharsethu@gmail.com7401240600

Outcome results

None listed

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