Extrait

Background and study aims
 In sub-Saharan Africa severe anaemia in children is a leading cause of hospital admission, a major cause of direct mortality. Guidelines developed by the World Health Organization (WHO) encourage the rational use of blood transfusion to preserve this scarce resource and to reduce the risk of transfusion-transmitted infections. The evidence base for the paediatric guidelines is weak and thus adherence is poor. Outcome of severe anaemia is unsatisfactory with high rates of in-hospital (9-10%) and 6-month (12%) case fatality, and relapse or re-hospitalisation (6%), indicating that the current recommendations and management strategies are not working in practice. At the moment we do not know whether a blood transfusion is the best way to treat this and then how to treat or prevent the underlying illnesses, which may have caused your child to have severe anaemia. Our aim is to: 1. Find out whether or not giving a blood transfusion is the best treatment. For children getting a blood transfusion we also do not know how much to give either the standard volume (dose) recommended in the current guidelines or a slightly higher volume (dose). We also want to find out whether or not giving extra treatments during the first three months after this hospital admission will prevent some of them from dying or becoming sick again. We will be looking at whether: 2. A multi vitamin multi mineral (MVMM) treatment called Sprinkles containing 15 different chemicals/vitamins is better than then usual recommended treatment of folate and iron. 3. Whether a single pill containing an antibiotic, cotrimoxazole, will fight infections and stop them from getting sick in the next 3 months. Who can participate?
 We will invite children, between the ages of 2 months to 12 years, at the point of hospital admission to take part in a study. The blood test to check whether the child has anaemia is called a haemoglobin level. Children with a haemoglobin (Hb) less that 6g/dl will be included in the study. What does the study involve? Children will be treated according to standard Ministry of Health guidelines for severe illness and/or severe malaria. 1. Transfusion: Children with a Hb below 4g/dl and those with Hb 4-6 g/dl with additional complications will all receive a transfusion. Half will receive the standard volume (dose) 20mg/kg of whole blood (as currently recommended) and the other half will receive a higher volume 30mg/kg. Children with a Hb 4-6 g/dl haemoglobin without complications will be randomly allocated either receiving no transfusion (current WHO recommendations) or to receiving 20mg/kg of whole blood (as currently recommended) or 30mg/kg. 2. Vitamin treatments Half the children will get iron and folate for 3 months (this is the current recommendation) while the other half will get a different MVMM medicine which is sprinkled onto their food every day for 3 months (or if the child is still breast feeding, mum will receive this medicine instead) to make the child’s blood stronger. 3. Infection prevention Often children with severe anaemia come back to hospital with another illness in the 6 months after this current admission. In order to try to prevent this, we will give half of the children a antibiotic tablet called cotrimoxazole for 3 months and the other half will not get this tablet. All children will have to come back after one month, three months and six months. We will check the health of your child at this visit, find out what food they have eaten on the day before they came to the clinic, find out whether they have been ill or to hospital since the last visit and check on whether they have been able to take the treatments and if they are causing any problem and then given them more treatments at the one month visit. When they come for these visits we will check on the strength of the blood (Hb level) and do a malaria test. What are the possible benefits and risks of participating? The direct benefits to the child and/or family include closer observation during the first 48 hours of admission, which, as a result, allows doctors and nurses to make important changes to the child’s treatment during in-hospital admission, as well as being able to detect and treat any complications as they arise. All routine non-trial medications prescribed to treat the child will be made available. The parents or guardians for the children will be asked to return for follow up at the clinic 28, 90 and 180 days after admission. Reimbursement for transport cost after discharge and for follow up visits plus any treatment costs required during the visits will be made. Risks are minimal. Both MVMM and cotrimoxazole prophylaxis have been widely used in children with minimal risk. Although substantial efforts have been made to ensure the safety of blood, failure to correctly cross-match and/or infected blood have the potential to cause harm. The study will directly evaluate whether these potential risks are outweighed by improved survival. TRACT teams will work closely with the local blood transfusion services (BTS) to ensure that recommended safety and quality control practices are being maintained. Where is the study run from? The study is being run from KEMRI Wellcome Trust Programme, P.O Box 230-80108, Kilifi, Kenya. It is being conducted at three hospitals in Uganda (Mulago National Referral Hospital, Kampala Mbale and Soroti Regional Referral Hospitals, Eastern Uganda) and Queen Elizabeth Hospital, Blantyre, Malawi. When is the study starting and how long is it expected to run for? We aim to start the trial in May 2013. We will involve nearly 4000 children across three hospitals and will be recruiting over three years. Who is funding the study? Medical Research Council and Department for International Development, UK Who is the main contact? Professor Kathryn Maitland [email protected]

Critère d'inclusion

• Severe anaemia

Liens

• isrctn
• ictrp