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A Comparative Analysis of 4% Chlorhexidine Versus Methylated Spirit as Prophylaxis of Omphalitis and Sepsis in Newborns

NCT06002295 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-08-23

No results posted yet for this study

Summary

Introduction: Neonatal sepsis in one of the leading cause of death in developing countries. Umbilical cord care is important as it may lead to infection. Topical treatment can help to reduce the chances of infection as well as increase the chances of early removal. In this regard methylated spirit and chlorhexidine are found to be effective.

Aims and Objectives: To compare the effectiveness of 4% chlorhexidine and methylated spirit in newborns for prevention of omphalitis and neonatal sepsis.

Materials and Methods: This randomized control trial was carried out in neonatal unit of Shaikh Zayed Hospital Lahore. After meeting the inclusion criteria, 300 neonates were enrolled. In group A 4% chlorhexidine was applied for cord care and in group B methylated spirit was used. Neonates were followed till 10th day of life. Careful examination was done for cord separation and for any signs of omphalitis or sepsis. If the neonate had no signs and symptoms of omphalitis and sepsis on 10th day of follow up then it was treatment success.

Conditions

  • Neonatal Sepsis
  • Omphalitis

Interventions

DRUG

Chlorhexidine Topical Cream

After approval from the hospital ethical committee, neonates fulfilling inclusion and exclusion criteria were selected. Written informed consent was obtained from the parents. Full instructions to avoid confounding variables like maintaining temperature and hygiene of newborn, frequent diaper change, avoidance of herbal tonics and cow milk; are given to mothers. In group "A" 4% chlorhexidine was applied generously over cord along with base of cord stump and surrounding skin thrice a day. In group "B" clean cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and base thrice a day.

DRUG

Methylated Spirit

After approval from the hospital ethical committee, neonates fulfilling inclusion and exclusion criteria were selected. Written informed consent was obtained from the parents. Full instructions to avoid confounding variables like maintaining temperature and hygiene of newborn, frequent diaper change, avoidance of herbal tonics and cow milk; are given to mothers. In group "A" 4% chlorhexidine was applied generously over cord along with base of cord stump and surrounding skin thrice a day. In group "B" clean cotton swab dipped in methylated spirit was used to clean cord along with cord clamps and base thrice a day.

Sponsors & Collaborators

  • Sheikh Zayed Federal Postgraduate Medical Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
10 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-12
Primary Completion
2021-09-22
Completion
2021-11-19

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002295 on ClinicalTrials.gov