Please select the eligibility criteria that correspond to the clinical trial below.
Title: Chemoprophylaxis With Sulfadoxine-pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years
Brief Summary: Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.


Options:
A: Inclusion Criteria:

* Age 6 months to 10 years
* Agree to seek initial medical care for all medical illness in the study clinic during the study period
* Written informed consent by a parent or legal garden,
* No plan to travel for a long time during the study period.

Exclusion Criteria:

* History of allergy to sulfa drugs or Sulfadoxine-pyrimethamine
* Chronic illness or symptomatic malaria at the time of enrollment
B: Inclusion Criteria:

1. Age: 3 months to 9 years.
2. Haemoglobin concentration 7g/dl on admission to hospital.
3. Residence within 30 km of the study centre and availability for the duration of the study period.
4. Informed consent to participate in the study given by the parent or guardian.

Exclusion Criteria:

1. Simultaneous participation in any other trial.
2. Allergy to sulpha drugs.
3. Residence \> 30 km from the recruitment site.
4. Lack of consent.
C: Inclusion Criteria:

* Permanent residence in the study area with no intention of leaving during the surveillance period.
* Obtention of informed consent.

Exclusion Criteria:

* Temporary residence in the study area.
* Absence of informed consent.
* Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
* A history of a previous, significant adverse reaction to either of the study drugs.
D: Inclusion Criteria:

* All infants attending EPI clinics at the 12 study health facilities for first vaccinations. Infants who live within the catchment area of the study health facility and are less than 3 months of age at the time of DPT and Polio 1 vaccination will be eligible for inclusion in the study.

Exclusion Criteria:

* Infants having any of the following conditions will be excluded: (1) history of allergy to study drugs; (2) history of convulsions; (3) clinical features of severe malnutrition or chronic illness including infants with signs of AIDS \[HIV prevalence in women of reproductive age in the study area was 11.5% in 1999\]39 (4) plans to leave the study area before 12 months of age.(5) weighs \<4.5 kgs (6) caretaker declines to give consent.

Answer: B