Clinical trial NCT01528852: Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis
Official title: Efficacy of Use of Chlorhexidine to Clean Umbilical Cord of Neonates in First 10 Days for Reduction in Neonatal Mortality and Omphalitis - A Community Based Randomized, Double Masked Controlled Trial in Pemba Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neonatal Mortality
Cord Care
Omphalitis
Keywords: neonatal Mortality
chlorhexidine cord care
cord infections
african settings
clinical trials
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Annamalai University
name: Ministry of Health and Social Welfare, Zanzibar
name: Bill and Melinda Gates Foundation
First posted: 2012-02-08
Enrollment: 36911
Sex: ALL
Minimum age (years): 1
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In a community-based controlled trial among children to evaluate if use of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life results in

* Reduction in neonatal mortality (deaths in first 28 days of life)
* Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life
* Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.

The double blind part of study uses a control preparation without chlorhexidine (CHX) as control group while in the sub-study dry cord care group is also evaluated as second control. Hypothesis is that CHX group will have lower mortality and umbilical cord infections while control group and dry cord group will be similar as shown in a previous study in Nepal.

Detailed description: Project Goal: The purpose of the trial is to evaluate the efficacy of cord cleansing with Chlorhexidine in the first 10 days of life in reducing neonatal mortality and morbidity. The study would provide a proof of principle for an intervention that could easily be scaled up.

Objectives of formative phase:

* Using TIPS (Trials of Improved Practices) methodology to evaluate the acceptance and impediments if any to practice of using liquid solution for cord cleaning including washing of hands with soap before and after use.
* To compare 3 modes (3 different packaging with application using cotton ball, dropper bottle and squeeze tube) of delivery for cord cleaning in terms of acceptance, ease of use and effectiveness in covering the target area.

Objectives of the main Trial :

Primary Objectives: In a double-blind community-based randomized controlled trial among 24,000 children to evaluate the efficacy of application of 4% Chlorhexidine cleansing solution on umbilical cord of infants in first 10 days of life compared to infants cleansed with a similar control solution without Chlorhexidine for:

* Reduction in neonatal mortality (deaths in first 28 days of life).
* Reduction in umbilical cord infections (defined by moderate or severe redness of the cord) during first 28 days of life.
* Reduction in umbilical cord infections (defined by pus formation with any degree of redness) during first 28 days of life.

Secondary Objectives: In a nested sub-study among 12,000 births (8000 from 24,000 double blind main study and 4000 additional births) randomized to three groups: Chlorhexidine cord care (n=4000), control solution cord care (n=4000) and dry cord care (n=4000):

* To evaluate the sensitivity and specificity of traditionally used "field definitions of omphalitis" based on a combination of signs and symptom in comparison to culture results using state of art sample collection/transport, culture and bacterial identification.
* To evaluate reductions in bacterial colonization rates from a) umbilical cord tip, b) stump and base area in Chlorhexidine and Control Solution groups compared to currently recommended dry cord care.

Eligibility criteria: Inclusion Criteria:

* Permanent resident of Pemba
* Consenting to participate, infants alive at first contact with MCH/TBA/Hospital staff
* First contact within 48 hours of delivery.

Exclusion Criteria:

* Congenital malformations where application of intervention is not possible
* Very sick child needing hospitalization and ICU care.

Primary outcomes:
measure: Neonatal Mortality
timeFrame: 28 days after birth
Secondary outcomes:
measure: Omphalitis
timeFrame: Birth to 28 days of life
Other outcomes:
Locations:
city: Pemba
country: Tanzania
facility: PHL-IDC
state: Zanzibar
Study officials:
References:
citation: Sazawal S, Dhingra U, Ali SM, Dutta A, Deb S, Ame SM, Mkasha MH, Yadav A, Black RE. Efficacy of chlorhexidine application to umbilical cord on neonatal mortality in Pemba, Tanzania: a community-based randomised controlled trial. Lancet Glob Health. 2016 Nov;4(11):e837-e844. doi: 10.1016/S2214-109X(16)30223-6. Epub 2016 Sep 29.
citation: Nangia S, Dhingra U, Dhingra P, Dutta A, Menon VP, Black RE, Sazawal S. Effect of 4 % chlorhexidine on cord colonization among hospital and community births in India: a randomized controlled study. BMC Pediatr. 2016 Aug 2;16:121. doi: 10.1186/s12887-016-0625-7.
citation: Dhingra U, Sazawal S, Dhingra P, Dutta A, Ali SM, Ame SM, Deb S, Suleiman AM, Black RE. Trial of improved practices approach to explore the acceptability and feasibility of different modes of chlorhexidine application for neonatal cord care in Pemba, Tanzania. BMC Pregnancy Childbirth. 2015 Dec 28;15:354. doi: 10.1186/s12884-015-0760-4.
citation: Dhingra U, Gittelsohn J, Suleiman AM, Suleiman SM, Dutta A, Ali SM, Gupta S, Black RE, Sazawal S. Delivery, immediate newborn and cord care practices in Pemba Tanzania: a qualitative study of community, hospital staff and community level care providers for knowledge, attitudes, belief systems and practices. BMC Pregnancy Childbirth. 2014 May 22;14:173. doi: 10.1186/1471-2393-14-173.