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Comparing the effect of three different skin antiseptic preparations in neonates( first 28 days of life)- randomized trial

Efficacy of three different antiseptic preparations in neonates admitted in NICU: a randomized noninferiority trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009890
Enrollment
357
Registered
2017-09-22
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- Admitted in NICU

Interventions

Intervention1: 2% CHG in 70 % isopropyl alcohol: Routine- Local application to skin Dose- around 0.5 to 1 ml applied to skin and dried Frequency- once per enrollment Duration- once Baby can be enrolle

Sponsors

AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All inborn neonates from 28-42 weeks of gestation requiring NICU admission for at least 48 hrs

Exclusion criteria

Exclusion criteria: 1. Major congenital malformation 2. Hydrops 3. Generalised skin disorder 4. Skin infection 5. Persistent pulmonary hypertension 6. Respiratory failure requiring high frequency ventilation

Design outcomes

Primary

MeasureTime frame
To compare the proportion of negative post cleansing skin swabs after the skin antisepsis performed by one of the following antiseptic solution -2 % CHG in 70 % isopropyl alcohol v/s 2 % CHG in aqueous v/s serial use of 70% isopropyl alcohol- 5 % povidone iodine- 70 % isopropyl alcohol in neonates 28- 42 weeks of gestation admitted in NICU in first 28 days of life.Timepoint: on day 3, 7,14, 28 if admitted in NICU—

Secondary

MeasureTime frame
1. To compare local skin reaction to antiseptic solution application Timepoint: at 0,6,12,24 hrs after application;Estimation of Chlorhexidine level in a subset of 50 patientsTimepoint: after 24 hrs application;Incidence of sepsisTimepoint: 28 days;Thyroid dysfunction by measuring T4 and TSH in a subset of 50 patientsTimepoint: 24 hrs after application—

Countries

India

Contacts

Public ContactDR SRIKANTH KULKARNI

AIIMS, New Delhi

ra.aiims@gmail.com

Outcome results

None listed

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