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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Omphalitis

Intervention / Treatment
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* Drug: 4% Chlorhexidine
* Other: Hand washing Soap
* Drug: 4% Chlorhexidine


Participation Criteria
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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.

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Neonatal Omphalitis |  | By the end of the styudy | 
| Rate of Neonatal Mortality |  | By the end of the Study | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omphalitis, 4% Chlorhexidine, Newborns