Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan
Chlorhexidine
1 other identifier
interventional
9,800
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJuly 8, 2011
July 1, 2009
1.7 years
May 19, 2008
July 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Neonatal Omphalitis
By the end of the styudy
Rate of Neonatal Mortality
By the end of the Study
Secondary Outcomes (4)
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
Study Arms (4)
A
EXPERIMENTALIn this arm we recruited 2,400 subjects who received Intervention.
B
EXPERIMENTALIn this Arm, we recruited 2,400 subjects who received intervention.
C
EXPERIMENTALIn this Arm, we recruited 2,400 subjects who received intervention.
D
NO INTERVENTIONIn this Arm, we recruited 2,400 subjects for Observation and comparison. This was the prime control group.
Interventions
4% Chlorhexidine was provided to be applied in this arm to Mothers through TBAs.
Eligibility Criteria
You may qualify if:
- All healthy newborns, born in the study setting will be systematically enrolled in the trial
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aga Khan Universitylead
- John Snow, Inc.collaborator
Study Sites (1)
Proejct Office
Dadu, Sindh, 75300, Pakistan
Related Publications (1)
Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8.
PMID: 22322126DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP
Aga Khan University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
January 1, 2008
Primary Completion
September 1, 2009
Study Completion
December 1, 2009
Last Updated
July 8, 2011
Record last verified: 2009-07