Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan (Chlorhexidine)

July 7, 2011 updated by: Aga Khan University

Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan: A Community-based Randomized Control Trial

The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prime objective of this study is to estimate the independent effect of 4% Chlorhexidine solution application to cord stump and hand washing with soap by mothers of newborns for 2 weeks after birth in reducing Omphalitis in neonates compared to routine cord care by TBAs (Traditional Birth Attendant) in rural district of Sindh, Pakistan.

This study will be conducted in existing health infrastructure in a community setting with the help of two principal health care providers, TBAs and CHWs Community Health Workers) involved in maternal and newborn care. The TBAs conducting delivery wil be trained to wash hands with soap and water after completion of delivery and apply chlorhexidine to the Umbilical Cord Stump. The procedure will be repeated by the mother on the subsequent days up til 14 days from birth. The CHWs will also be trained to recognized signs of Omphalitis and record Cord Care in a systemic manner in a structured proforma.

The study will continue longitudinally for a period of one year to follow newborn for the signs of Omphalitis.

Study Type

Interventional

Enrollment (Actual)

9800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Dadu, Sindh, Pakistan, 75300
        • Proejct Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All healthy newborns, born in the study setting will be systematically enrolled in the trial

Exclusion Criteria:

  • Infants with congenital/birth defects
  • Infants with any localized infection on the peri-umbilical region at the time of birth or application of any other material such as dung, etc before enrollment on the Cord.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
In this arm we recruited 2,400 subjects who received Intervention.
Drug: 4% Chlorhexidine
4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.
Drug: 4% Chlorhexidine
4% Chlorhexidine was provided to be applied by Mothers through TBAs.
Experimental: B
In this Arm, we recruited 2,400 subjects who received intervention.
Other: Hand washing Soap
Hand washing soap was provided to Mothers through TBAs.
Experimental: C
In this Arm, we recruited 2,400 subjects who received intervention.
Drug: 4% Chlorhexidine
4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.
Drug: 4% Chlorhexidine
4% Chlorhexidine was provided to be applied by Mothers through TBAs.
No Intervention: D
In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Neonatal Omphalitis
Time Frame: By the end of the styudy
By the end of the styudy
Rate of Neonatal Mortality
Time Frame: By the end of the Study
By the end of the Study

Secondary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding rate
Time Frame: By the end of the Study
By the end of the Study
Rate of Serious Neonatal Infections
Time Frame: By the end of the Study
By the end of the Study
Utilization of Clean Delivery Kits
Time Frame: By the end of the Study
By the end of the Study
Application Practice of Chlorhexidine
Time Frame: By the end of the Study
By the end of the Study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

John Snow, Inc.

Investigators

  • Principal Investigator: Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP, The Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

July 8, 2011

Last Update Submitted That Met QC Criteria

July 7, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 683-Ped/ERC-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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