Anaemia Clinical Trial
— EARSOfficial title:
A Cluster Randomised Trial of Different Methods of Haemoglobin Measurement to Improve Recognition and Treatment of Childhood and Pregnancy-related Anaemia in a Malaria Endemic Area of North East Tanzania.
Verified date | May 2010 |
Source | London School of Hygiene and Tropical Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | Tanzania: Ministry of Health |
Study type | Interventional |
A high proportion of children under the age of 5 years and pregnant women in Tanzania is
anaemic, particularly in areas of high malaria transmission. The symptoms of anaemia are
often non-specific or absent and clinical judgement is generally insensitive in estimating
Hb levels, especially in infants who are assessed by basic grade health staff. Thus while
treatment for the common causes of anaemia is available, many cases are not treated due to
difficulties in recognising anaemia.
New diagnostic tools can increase the sensitivity of anaemia detection compared to clinical
diagnosis but no studies have demonstrated their effectiveness in increasing case-detection
and treatment of anaemic patients at the first level of healthcare. In addition, the costs
of their use in relation to any increase in numbers of cases treated are not known and this
knowledge is needed to guide public health decisions.
Two methods of measuring anaemia are currently suitable for use at the first level of care;
Copack Haemoglobin colour scale (HBCS) and Hemocue portable photometry. We propose to
compare the effectiveness in basic health facilities of these 2 simple diagnostic tools
compared to control dispensaries (current practice) in increasing rates of detection and
treatment of anaemia in children under the age of 5 years and pregnant women over the course
of 1 year in a cluster-randomised trial in 30 dispensaries in a malaria-endemic area of NE
Tanzania.
Status | Completed |
Enrollment | 450 |
Est. completion date | May 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 5 Years |
Eligibility |
Inclusion Criteria: - Age under 5 years - Pregnancy - Suspected anaemia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Tanzania | Handeni District Health Facilities | Tanga |
Lead Sponsor | Collaborator |
---|---|
London School of Hygiene and Tropical Medicine | National Institute for Medical Research, Tanzania |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of clinic attenders under the age of 5 years who are diagnosed with anaemia (adjusted for anaemia in the community) | 1 year | ||
Secondary | Proportion of anaemic children and pregnant women treated for anaemia | 1 year | ||
Secondary | Prevalence of anaemia in study communities by age and season | 1 year | ||
Secondary | Proportion of clinic attenders referred to the district hospital with Hb> and <8g/dl. | 1 year | ||
Secondary | Effectiveness of current MOH anaemia treatment regimens. | 1 year | ||
Secondary | Acceptability of HBCS and Hemocue and attitudes to anaemia diagnosis among caretakers and healthworkers | 1 year | ||
Secondary | Cost effectiveness of HBC or Hemocue compared to current practice in increasing anaemia diagnosis. | 1 year |
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