RCT Iron Supplementation and Malaria Chemoprophylaxis for Prevention of Severe Anemia and Malaria in Tanzanian Infants

The Prevention of Anaemia and Malaria in Infants in an Area of Intense and Perennial Malaria Transmission

The purpose of this trial is to evaluate the efficacy of weekly iron supplementation and the efficacy of malaria chemoprophylaxis from 2 to 12 months of age in infants living in an area of intense and perennial malaria transmission

411 Tanzanian infants were randomly assigned to receive weekly malaria prophylaxis with Deltaprim™ (3.125 mg pyrimethamine plus 25 mg dapsone) or placebo from ages 2-12 months. Children were followed-up until age 4 years. Uncomplicated febrile malaria, severe malaria and anaemia morbidity were assessed through hospital-based passive surveillance.

Inclusion Criteria:

• Born in San Francis Designated District Hospital of Ifakara

Exclusion Criteria:

• Obvious severe congenital malformation such as: spina bifida, hydrocephalus or anencepahlus
• Twins
• Birth weight < 1,5 kg
• Clinical signs of cerebral asphyxia
• Clinical signs of neonatal or congenital infection
• Mother unreliable (deaf, mentally handicapped)