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To determine effectiveness and safety of octenidine wipes in babies admitted in the neonatal intensive care unit

A randomised pilot control study to determine the safety,feasibility and effectiveness of octenidine on skin bacterial burden of neonates admitted in the neonatal intensive care unit

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/028918
Enrollment
60
Registered
2020-11-05
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

Health Condition 1: L988- Other specified disorders of the skin and subcutaneous tissue

Interventions

Intervention1: Octenidine wipe: Routine sponging of babies with octenidine as per randomisation protocol for routine sponging after 72 hours of life and then even every 48 hours Control Intervention1:

Sponsors

Bharati Hospital and research centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates admitted in level 3 NICU, Bharati hospital and research centre (inborn as well as outborn), a) Babies born at more than 28 weeksââ?¬• gestation and postnatal age of at least 24 hours OR b) Babies admitted to NICU who are more than 4 weeks old

Exclusion criteria

Exclusion criteria: Neonates with a) congenital skin anomalies b) extremely sick newborns, not allowing routine bathing care. Extremely sick being defined as those newborns not mandating any kind of external movement for eg. those on high frequency oscillatory ventilation or those with pulmonary hypertension and requiring multiple inotropes c) born less than 28 weeksââ?¬• gestation and less than 4 weeks of chronological age

Design outcomes

Primary

MeasureTime frame
Feasibility and acceptability of Octenidine wipes as a routine cleansing measure for babies admitted to NICU Arm and groin Gram Negative colonization, measured in log CFU/ml, at baseline and 48 hours after the first octenidine wipe use.Timepoint: At baseline meaning at 72 hours of life and again after 48 hours after usage of first wipe

Secondary

MeasureTime frame
Arm and groin Gram Positive bacterial colonization, measured in log CFU/ml, at baseline and 48 hours after the first octenidine wipe use. Timepoint: 0 and 48 hours

Countries

India

Contacts

Public ContactReema Garegrat

Department of Neonatology ,bharati Hospital

banaitnishant@gmail.com

Outcome results

None listed

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