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

NCT06002295 | Completed Phase 2

• 1 other identifier: SZMC/IRB/Internal/MD/130/19
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of participants with Omphalitis

  Inflammation of the navel in newborn babies as assessed by redness and swelling of the area.

  10 days

Secondary Outcomes (1)

• Number of participants with Neonatal Sepsis

  10 days

Study Arms (2)

Umbilical Cord Care with Chlorhexidine (Group A)

EXPERIMENTAL

Drug: Chlorhexidine Topical Cream

Umbilical Cord Care with Methylated Spirit (Group B)

EXPERIMENTAL

Drug: Methylated Spirit

Interventions

Chlorhexidine Topical Cream DRUG

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.

Umbilical Cord Care with Chlorhexidine (Group A)

Methylated Spirit DRUG

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.

Umbilical Cord Care with Methylated Spirit (Group B)

Eligibility Criteria

• Age: 1 Day - 10 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term neonates of either gender born via cesarean section or spontaneous vaginal delivery at Shaikh Zayed Hospital after taking informed consent of parents.
• Antiseptic agent started from 1st day of life \& up to 10 days continued without missing dose

You may not qualify if:

• Newborns with congenital defects or cord anomalies.
• Laboratory or clinical evidence of sepsis.
• Preterm newborns
• Newborns having very low birth weight \<1.5 kg
• Any evidence of asphyxia during birth.

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead

Study Sites (1)

Sheikh Zayed Federal Postgraduate Medical Institute

Lahore, Punjab Province, 54500, Pakistan

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: September 12, 2020
• Primary Completion: September 22, 2021
• Study Completion: November 19, 2021
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)