Clinical trial · Interventional
Prevention of Severe Anaemia in Gambian Children
Chemoprophylaxis With Sulfadoxine-pyrimethamine to Prevent Recurrence of Severe Anaemia in Gambian Children Aged 3 Months to 9 Years
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sulfadoxine-pyrimethamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl
- timeFrame
- at end of the malaria transmission season
- measure
- haemoglobin concentration
- timeFrame
- At the end of malaria transmission season
- measure
- hemoglobin concentration
- timeFrame
- at the end of malaria transmission season
Secondary outcomes (8)
- measure
- Proportion of children with anaemia (Hb <11g/dl) and those with severe anaemia (Hb <5 g/dl)
- timeFrame
- at end of the malaria transmission season
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Months
- Maximum age
- 9 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBojang KA, Milligan PJ, Conway DJ, Sisay-Joof F, Jallow M, Nwakanma DC, Abubakr I, Njie F, Greenwood B. Prevention of the recurrence of anaemia in Gambian children following discharge from hospital. PLoS One. 2010 Jun 21;5(6):e11227. doi: 10.1371/journal.pone.0011227. PMID 20574541