BOX 1

A Summary of the Methods Used in Each IPTi-SP Study to Detect Critical Outcomes Including Clinical Malaria and (Depending on the Specific Study) Anemia, Hospitalization of Patients with Malaria Parasites, and All Cause Hospitalizations

Study

Surveillance Methods

Ifakara Schellenberg 2001

Passive and active (three-monthly cross-sectional surveys including blood smears): “A round-the-clock hospital-based clinical surveillance system has been operating since 1994 and is described in detail elsewhere. In brief, at each consultation, and after identification of the patient, a detailed standardized questionnaire was completed documenting signs and symptoms. Blood films were prepared for malaria parasite examination, and the packed-cell volume was measured if there was a history of fever in the preceding 24 h, if the axillary temperature was at least 37..5°C, or if the child appeared pale. Costs of treatment for children in the study were covered by the project. Blood samples were collected to assess seroconversion to EPI vaccines (DTP/OPV at 9 months, measles at 12 months), haemoglobin genotype (12 months), packed cell volume, and P falciparum parasitaemia (12 and 18 months). Because follow-up was based on passive case detection and cross-sectional surveys, we checked the vital status of each child by home visits at 12, 15, and 18 months of age.”

Navrongo Chandramohan 2005

Passive and active (cross-sectional surveys including blood smears at 3, 9, 12 and 18 months and visit to detect illness at 23 months): “All study infants were given a photo identity card, and their guardians were asked to bring the card whenever they visited an EPI clinic or other health facility. A field worker visited the households of study infants one or two days before the date when DPT-2 (IPT-1), DPT-3 (IPT-2), and measles (IPT-3) vaccinations were due to remind caretakers to attend an EPI clinic. A similar visit was made shortly before the IPT-4 administration at the age of 12 months was due. Finger prick blood samples for assessing packed cell volume, malaria parasitaemia, and the immune response to EPI vaccines were taken when infants received IPT-1, IPT-3, and IPT-4…Study children were visited at home at 18 months of age to collect finger prick blood samples for assessing packed cell volume and the presence of malaria parasitaemia and again at 23 months of age to assess their health…A fieldworker visited a random 20% sample of study children at home within four weeks after administration of IPT dose 1 or dose 2 to assess adherence to administration of iron at home and to inquire about adverse events.”

Manhiça Macete 2006

Passive and active (cross-sectional serological surveys at months 3, 4, 5, 9, 12; blood smears only at 12 months or if ill or febrile): “Parents were encouraged to attend the outpatient clinic at the Manhiça Health Center and the Maragra Health Post whenever the child became ill. An around-the-clock hospital-based clinical surveillance system has been operating in the area since 1997 and has been described in detail elsewhere. In brief, at each consultation, a detailed standardized questionnaire was completed that documented signs and symptoms. Blood films were prepared for malaria-parasite examination, and the packed cell volume (PCV) was measured if there was a history of fever during the preceding 24 h or if the infant’s axillary temperature was greater or equal than 37.5 °C. Episodes of uncomplicated malaria in study infants were treated with 7 days of oral quinine if the IPTi intervention had been administered within the preceding 2 weeks. Besides the



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