A study for comparing the rates of infection among babies less than a month cleansed daily either with a chemical(octenidine) or clean water in a neonatal care unit.

A randomised control trial to compare the late onset sepsis rates between neonates cleansed using octenidine wipes and those cleansed using sterile water in the NICU - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056562

Enrollment

528

Registered

2023-08-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: P36- Bacterial sepsis of newborn Health Condition 2: P36- Bacterial sepsis of newborn

Interventions

Intervention1: OCTENIDINE WIPES: Daily whole-body skin cleansing with octenidine wipes until discharge/transfer from the unit. One wipe or gauze piece will be used to clean the upper body, including

Eligibility

Inclusion criteria

Inclusion criteria: Neonates admitted within 48 hours of life to level 3 and 2 neonatal intensive care unit

Exclusion criteria

Exclusion criteria: Pre-existing raw skin lesions Outborn neonates with clinical sepsis or culture positive sepsis on admission Outborn neonates admitted after 24hours of life Parents unwilling to enroll their baby in the study

Design outcomes

Primary

Measure	Time frame
Late-onset culture proven or clinical sepsisTimepoint: Discharge or transfer out from NICU(level 2 and/or 3)	—

Secondary

Measure	Time frame
Late-onset culture proven or clinical sepsisTimepoint: Within 7 days of admission Within 14 days of admission;Local adverse reaction to octenidine wipesTimepoint: Through out the study	—

Countries

India

Contacts

Public ContactDr Suprabha K Patnaik

Bharati Vidyapeeth deemed to be university

drsipi@gmail.com9650138130

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jul 17, 2026