Clinical trial NCT00682006: Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Omphalitis
Keywords: Omphalitis
4% Chlorhexidine
Newborns
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: John Snow, Inc.
First posted: 2008-05-21
Enrollment: 9800
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of Neonatal Omphalitis
timeFrame: By the end of the styudy
measure: Rate of Neonatal Mortality
timeFrame: By the end of the Study
Secondary outcomes:
measure: Breastfeeding rate
timeFrame: By the end of the Study
measure: Rate of Serious Neonatal Infections
timeFrame: By the end of the Study
measure: Utilization of Clean Delivery Kits
timeFrame: By the end of the Study
measure: Application Practice of Chlorhexidine
timeFrame: By the end of the Study
Other outcomes:
Locations:
city: Dadu
country: Pakistan
facility: Proejct Office
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar Dr Bhutta, MBBS, PhD, FRCP, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.