Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan
Information source: Aga Khan University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Omphalitis
Intervention: 4% Chlorhexidine (Drug); Hand washing Soap (Other); 4% Chlorhexidine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Aga Khan University Official(s) and/or principal investigator(s):
Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP, Principal Investigator, Affiliation: The Aga Khan University
Overall contact:
Mir Mr Khan, MBA, Phone: 92-21-493-0051, Ext: 4385, Email: asghar.ali@aku.edu
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.
Clinical Details
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
Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Incidence of Neonatal OmphalitisRate of Neonatal Mortality
Secondary outcome: Breastfeeding rateRate of Serious Neonatal Infections Utilization of Clean Delivery Kits Application Practice of Chlorhexidine
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.
Eligibility
Minimum age: N/A.
Maximum age: 28 Days.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Mir Mr Khan, MBA, Phone: 92-21-493-0051, Ext: 4385, Email: asghar.ali@aku.edu
Proejct Office, Dadu, Sindh 75300, Pakistan; Recruiting
Naveed Dr Bhutto, MBBS, Phone: 92-300-923-2139, Email: naveed.bhutto@aku.edu
Mir Mr Khan, MBA, Phone: 92-21-493-0051, Ext: 4385, Email: asghar.ali@aku.edu
Additional Information
Starting date: January 2008
Last updated: July 16, 2009
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