Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan
- Registration Number
- NCT00682006
- Lead Sponsor
- Aga Khan University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9800
- All healthy newborns, born in the study setting will be systematically enrolled in the trial
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A 4% Chlorhexidine In this arm we recruited 2,400 subjects who received Intervention. B Hand washing Soap In this Arm, we recruited 2,400 subjects who received intervention. C 4% Chlorhexidine In this Arm, we recruited 2,400 subjects who received intervention.
- Primary Outcome Measures
Name Time Method Incidence of Neonatal Omphalitis By the end of the styudy Rate of Neonatal Mortality By the end of the Study
- Secondary Outcome Measures
Name Time Method Utilization of Clean Delivery Kits By the end of the Study Application Practice of Chlorhexidine By the end of the Study Breastfeeding rate By the end of the Study Rate of Serious Neonatal Infections By the end of the Study
Trial Locations
- Locations (1)
Proejct Office
🇵🇰Dadu, Sindh, Pakistan