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

Omphalitis Clinical Trial

— Chlorhexidine  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682006
• Other study ID #: 683-Ped/ERC-06
• Status: Completed
• Phase: Phase 3
• First received: May 19, 2008
• Last updated: July 7, 2011
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: July 2009
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9800
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Omphalitis

Intervention

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

Other:
• Hand washing Soap
Hand washing soap was provided to Mothers through TBAs.

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

Locations

Country	Name	City	State
Pakistan	Proejct Office	Dadu	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	John Snow, Inc.

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Neonatal Omphalitis		By the end of the styudy	No
Primary	Rate of Neonatal Mortality		By the end of the Study	No
Secondary	Breastfeeding rate		By the end of the Study	No
Secondary	Rate of Serious Neonatal Infections		By the end of the Study	No
Secondary	Utilization of Clean Delivery Kits		By the end of the Study	No
Secondary	Application Practice of Chlorhexidine		By the end of the Study	No