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. 2021 Jul 17;2021(7):CD011525. doi: 10.1002/14651858.CD011525.pub3

Mockenhaupt 2007 GHA.

Study characteristics
Methods Trial design: RCT
Trial dates: March 2003 to July 2005
Length of follow‐up: 24 months of age
Participants Number of participants: 1200 infants
Inclusion criteria: parental informed consent and permanent residence in the study area
Exclusion criteria: conditions requiring hospital admission, signs of hepatic or renal dysfunction, and reported allergy to sulfa‐containing drugs
Interventions

  • Intervention: IPTi with SP at approximately 3, 9, and 15 months of age.1/2 tablet of SP (125/6.25 mg of sulfadoxine and pyrimethamine, respectively, per kg of body weight)

  • Placebo: identical placebos given at the same time points with iPTi


All participants received routine immunization with diphtheria‐pertussis‐tetanus‐Haemophilus influenzae type b‐hepatitis B virus dose 2, measles, and yellow fever vaccinations.
Outcomes Outcomes included in the review

  • Clincal malaria

  • All‐cause mortality

  • Hospital admissions

  • Anaemia

  • Parasitaemia


Outcomes not included in the review: none
Notes Location: Tamale, Ghana
Malaria transmission: hyperendemic/perennial transmission and modest seasonal variation
Funding: German Ministry of Education and Research (grant 01KA0202), the German Academic Exchange Service (DAAD), and Charite´—University Medicine Berlin (grant 2005‐543)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The trial used block randomization
Allocation concealment (selection bias) Low risk The trial used identical, centrally coded drug containers
Blinding of participants and personnel (performance bias)
All outcomes Low risk "The study team and caretakers of children were blinded to the treatment regimen. The randomisation and drug code lists were kept by an individual not involved in the analysis of the study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk "The study team and caretakers of children were blinded to the treatment regimen. The randomisation and drug code lists were kept by an individual not involved in the analysis of the study"
Incomplete outcome data (attrition bias)
All outcomes Low risk There was no missing outcome data. The percentage loss was 5.5%
Selective reporting (reporting bias) Low risk The published report included key outcomes
Other bias Low risk The trial appears free of other sources of bias