title: Mortality, Morbidity, and Developmental Outcomes in Infants Born to Women Who Received Either Mefloquine or Sulfadoxine-Pyrimethamine as Intermittent Preventive Treatment of Malaria in Pregnancy: A Cohort Study.
abstract: BACKGROUND
  Little is known about the effects of intermittent preventive treatment of malaria in pregnancy (IPTp) on the health of sub-Saharan African infants. We have evaluated the safety of IPTp with mefloquine (MQ) compared to sulfadoxine-pyrimethamine (SP) for important infant health and developmental outcomes.
  
  
  RESULTS
  In the context of a multicenter randomized controlled trial evaluating the safety and efficacy of IPTp with MQ compared to SP in pregnancy carried out in four sub-Saharan countries (Mozambique, Benin, Gabon, and Tanzania), 4,247 newborns, 2,815 born to women who received MQ and 1,432 born to women who received SP for IPTp, were followed up until 12 mo of age. Anthropometric parameters and psychomotor development were assessed at 1, 9, and 12 mo of age, and the incidence of malaria, anemia, hospital admissions, outpatient visits, and mortality were determined until 12 mo of age. No significant differences were found in the proportion of infants with stunting, underweight, wasting, and severe acute malnutrition at 1, 9, and 12 mo of age between infants born to women who were on IPTp with MQ versus SP. Except for three items evaluated at 9 mo of age, no significant differences were observed in the psychomotor development milestones assessed. Incidence of malaria, anemia, hospital admissions, outpatient visits, and mortality were similar between the two groups. Information on the outcomes at 12 mo of age was unavailable in 26% of the infants, 761 (27%) from the MQ group and 377 (26%) from the SP group. Reasons for not completing the study were death (4% of total study population), study withdrawal (6%), migration (8%), and loss to follow-up (9%).
  
  
  CONCLUSIONS
  No significant differences were found between IPTp with MQ and SP administered in pregnancy on infant mortality, morbidity, and nutritional outcomes. The poorer performance on certain psychomotor development milestones at 9 mo of age in children born to women in the MQ group compared to those in the SP group may deserve further studies.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00811421.
authors.affiliation: ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.|Manhiça Health Research Centre (CISM), Manhiça, Mozambique.|Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Rupérez
authors.affiliation: ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.|Manhiça Health Research Centre (CISM), Manhiça, Mozambique.
authors.forename: Raquel
authors.initials: R
authors.lastname: González
authors.affiliation: Centre de Recherches Médicales de Lambaréné, Albert Schweitzer Hospital, Lambaréné, Gabon.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.|Department of Parasitology, Leiden Medical University Center, Leiden, The Netherlands.|Ngounié Medical Research Centre, Fougamou, Gabon.
authors.forename: Ghyslain
authors.initials: G
authors.lastname: Mombo-Ngoma
authors.affiliation: Ifakara Health Institute (IHI), Dodoma, Tanzania.
authors.forename: Abdunoor M
authors.initials: AM
authors.lastname: Kabanywanyi
authors.affiliation: Manhiça Health Research Centre (CISM), Manhiça, Mozambique.
authors.forename: Esperança
authors.initials: E
authors.lastname: Sevene
authors.affiliation: Faculté des Sciences de la Santé (FSS), Université d'Abomey-Calavi, Cotonou, Benin.|Institut de Recherche pour le Développement (IRD), Paris, France.
authors.forename: Smaïla
authors.initials: S
authors.lastname: Ouédraogo
authors.affiliation: Ifakara Health Institute (IHI), Dodoma, Tanzania.
authors.forename: Mwaka A
authors.initials: MA
authors.lastname: Kakolwa
authors.affiliation: Manhiça Health Research Centre (CISM), Manhiça, Mozambique.
authors.forename: Anifa
authors.initials: A
authors.lastname: Vala
authors.affiliation: Faculté des Sciences de la Santé (FSS), Université d'Abomey-Calavi, Cotonou, Benin.|Institut de Recherche pour le Développement (IRD), Paris, France.
authors.forename: Manfred
authors.initials: M
authors.lastname: Accrombessi
authors.affiliation: Institut de Recherche pour le Développement (IRD), Paris, France.|Université René Descartes, Paris, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Briand
authors.affiliation: ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.|Manhiça Health Research Centre (CISM), Manhiça, Mozambique.
authors.forename: John J
authors.initials: JJ
authors.lastname: Aponte
authors.affiliation: Centre de Recherches Médicales de Lambaréné, Albert Schweitzer Hospital, Lambaréné, Gabon.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.|Ngounié Medical Research Centre, Fougamou, Gabon.
authors.forename: Rella
authors.initials: R
authors.lastname: Manego Zoleko
authors.affiliation: Centre de Recherches Médicales de Lambaréné, Albert Schweitzer Hospital, Lambaréné, Gabon.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.|Department of Parasitology, Leiden Medical University Center, Leiden, The Netherlands.
authors.forename: Ayôla A
authors.initials: AA
authors.lastname: Adegnika
authors.affiliation: Institut de Recherche pour le Développement (IRD), Paris, France.|Université René Descartes, Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Cot
authors.affiliation: Centre de Recherches Médicales de Lambaréné, Albert Schweitzer Hospital, Lambaréné, Gabon.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kremsner
authors.affiliation: Faculté des Sciences de la Santé (FSS), Université d'Abomey-Calavi, Cotonou, Benin.
authors.forename: Achille
authors.initials: A
authors.lastname: Massougbodji
authors.affiliation: Ifakara Health Institute (IHI), Dodoma, Tanzania.
authors.forename: Salim
authors.initials: S
authors.lastname: Abdulla
authors.affiliation: Centre de Recherches Médicales de Lambaréné, Albert Schweitzer Hospital, Lambaréné, Gabon.|Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany.|Division of Infectious Diseases and Tropical Medicine I, Department of Medicine I, Medical University of Vienna, Vienna, Austria.
authors.forename: Michael
authors.initials: M
authors.lastname: Ramharter
authors.affiliation: Manhiça Health Research Centre (CISM), Manhiça, Mozambique.
authors.forename: Eusébio
authors.initials: E
authors.lastname: Macete
authors.affiliation: ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.|Manhiça Health Research Centre (CISM), Manhiça, Mozambique.|Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
authors.forename: Clara
authors.initials: C
authors.lastname: Menéndez
mesh_terms: D000328:Adult; D000353:Africa, Southern / Q000453:epidemiology; D000962:Antimalarials / Q000627:therapeutic use; D002648:Child; D002657:Child Development / Q000187:drug effects*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008288:Malaria / Q000517:prevention & control*; D018811:Maternal Exposure / Q000009:adverse effects*; D015767:Mefloquine / Q000009:adverse effects* / Q000627:therapeutic use; D009017:Morbidity / Q000639:trends; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000517:prevention & control*; D011297:Prenatal Exposure Delayed Effects / Q000139:chemically induced / Q000453:epidemiology*; D011739:Pyrimethamine / Q000627:therapeutic use*; D013413:Sulfadoxine / Q000627:therapeutic use*; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D004338:Drug Combinations; C001205:fanasil, pyrimethamine drug combination; D013413:Sulfadoxine; D015767:Mefloquine; D011739:Pyrimethamine