Chlorhexidine Cordcare for Reduction in Neonatal Mortality and Omphalitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36911 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-19

Study Completion Date

2014-09-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Chlorhexidine Skin Cleansing on Skin Flora

NCT00198679

Skin Diseases, Infectious

COMPLETED PHASE4

Zambia Chlorhexidine Application Trial

NCT01241318

Sepsis

COMPLETED PHASE2/PHASE3

Etiology, Prevention and Treatment of Neonatal Infections in the Community

NCT00198627

Bacterial Infection Infectious Disease

COMPLETED NA

Evaluation of Novel Antimicrobial Hand Towels

NCT02512614

Diarrheal Diseases Acute Respiratory Infections Fever +1 more

COMPLETED PHASE2/PHASE3

Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants

NCT03390374

Fungal Infections Systemic

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Mortality Cord Care Omphalitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CHX Cord application

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.