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Umbilical cord care comparing topical Chlorhexidine versus standard dry cord care in a hospital setting

â??EFFECT OF TOPICAL APPLICATION OF CHLORHEXIDINE FOR UMBILICAL CORD CARE IN COMPARISON WITH STANDARD DRY CORD CARE PRACTICE ON THE RISK OF NEONATAL SEPSIS IN A HOSPITAL SETTING: A RANDOMIZED CONTROLLED TRIALâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048552
Enrollment
116
Registered
2022-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: P38- Omphalitis of newborn

Interventions

Intervention1: Intervention Arm (chlorhexidine care group): Chlorhexidine gluconate gel 7.1 % (delivering 4% chlorhexidine) will be applied on the umbilical cord (base and stump) Once a day for first

Sponsors

Himanshu Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newborns with gestational age >32 weeks and weighing >1500 g at birth who will be consecutively admitted to NICU, within the first 24 hours of birth will be enrolled for the study

Exclusion criteria

Exclusion criteria: 1. Newborns with any anomaly involving umbilical cord 2. Neonates requiring umbilical catheterization 3. Neonates those who are likely to get discharged within the first 7 days of birth 4. Parents unwilling for inclusion in the study 5. Neonates with major congenital anomalies, moderate to severe HIE, neonates with severe illness who are likely to die within 48-72 hours

Design outcomes

Primary

MeasureTime frame
Cord separation time Timepoint: It will be measured in hours (Till 14 days)

Secondary

MeasureTime frame
DeathTimepoint: Will be recorded in a predesigned patient proforma Only death ascribed to any type of sepsis within the first week of life will only be taken into account;Incidence of umbilical sepsis Timepoint: The cord will be observed twice daily for signs of sepsis including erythema, swelling, induration and discharge, if any. Umbilical swabs for culture and sensitivity will be sent on third and seventh day of life;Probable sepsisTimepoint: Clinically symptomatic neonate with atleast two of these three parameters in first week of life: C reactive protein 10 mg/l, total leucocytes 5000/cmm and absolute neutrophil count 1800/cmm, and without any growth in blood culture Samples will be sent only in neonates with symptoms suggestive of sepsis

Countries

India

Contacts

Public ContactMangalabharathi

Madras Medical College

drmangalabharathi@gmail.com9840786836

Outcome results

None listed

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