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