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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Omphalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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B

In this Arm, we recruited 2,400 subjects who received intervention.

Group Type EXPERIMENTAL

Hand washing Soap

Intervention Type OTHER

Hand washing soap was provided to Mothers through TBAs.

C

In this Arm, we recruited 2,400 subjects who received intervention.

Group Type EXPERIMENTAL

4% Chlorhexidine

Intervention Type DRUG

4% Chlorhexidine was provided to be applied by Mothers through TBAs.

D

In this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

A

In this arm we recruited 2,400 subjects who received Intervention.

Group Type EXPERIMENTAL

4% Chlorhexidine

Intervention Type DRUG

4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.

Interventions

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4% Chlorhexidine

4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.

Intervention Type DRUG

Hand washing Soap

Hand washing soap was provided to Mothers through TBAs.

Intervention Type OTHER

4% Chlorhexidine

4% Chlorhexidine was provided to be applied by Mothers through TBAs.

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No