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Chlorhexidine application on umbilical cord and adverse health outcomes in preterm babies

Chlorhexidine 4% application on umbilical cord versus dry cord care in preterm babies less than 32 weeks of gestation: an open label randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013259
Enrollment
600
Registered
2018-04-13
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- Preterm Newborns less than 32 completed weeks of gestation

Interventions

Intervention1: Chlorhexidine 4%: Chlorhexidine 4% daily application on umbilical cord till three days after the separation of umbilical cord Control Intervention1: Dry umbilical cord care: nothing wou

Sponsors

Post Graduate Institute of Medical Education and Research Chandigarh
Lead Sponsor
Dr Praveen Kumar
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Born between gestation of 26+0 to 31+6 weeks

Exclusion criteria

Exclusion criteria: Congenital malformations involving the cord Major congenital malformation Unlikely to stay in PGIMER for ongoing care Consent not obtained within two hours of birth

Design outcomes

Primary

MeasureTime frame
Adverse Health outcome defined as as occurrence of any one of the following: (a) neonatal mortality (b) neonatal sepsis (c) necrotizing enterocolitis more than/equal to stage 2 (d) retinopathy of prematurity needing treatment (e) intraventricular hemorrhage more than/equal to grade 2 (f) bronchopulmonary dysplasia.Timepoint: 28 days except for ROP(3 months)

Secondary

MeasureTime frame
Outcome Name: incidence of omphalitis Outcome Name: incidence of adverse reactions following chlorhexidine application Outcome Name: rate of antibiotic usage Outcome Name: mean cord separation timeTimepoint: Time-points: till 3 days of umbilical cord separation Time-points: till 3 days of umbilical cord separation Time-points: 28 days Time-points: till cord separation

Countries

India

Contacts

Public ContactDr Praveen Kumar

Post Graduate Institute of Medical Education and Research Chandigarh

drpkumarpgi@gmail.com9478366925

Outcome results

None listed

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