Congenital and Neonatal Malaria in Mali
Congenital and Neonatal Malaria in Mali
This study will look at blood samples taken from 300 preterm babies and newborns admitted for
 inpatient care at Hopital Gabriel Toure in Bamako, Mali, and to gather information that will
 help the investigators verify the role of malaria in illness of very small babies. Blood
 samples will be taken from the mothers so that the investigators can find out if they have a
 malaria infection and how their body fights malaria. The investigators will also determine
 whether the mother and newborn baby are infected with the same malaria parasite. The
 information from this study may be used to improve malaria treatment in very small babies.
 Mothers and babies whose blood is tested will receive treatment for malaria as recommended by
 the National Malaria Control Program (NCMP).
The purpose of this cross-sectional study is to determine the rate of congenital and acquired
 malaria in inpatient neonates at a tertiary pediatric hospital in Bamako, Mali. The primary
 study endpoint will be the number of infants with malaria infection as detected by the
 positivity of one of the three malaria diagnosis assays. The secondary study endpoints will
 be: (1) the rate of congenital malaria, (2) the rate of acquired malaria, (3) the prevalence
 of antimalarial antibodies in neonates, and (4) the prevalence of specific hemoglobin types
 in the study population. Neonates of both sexes who weigh at least 2000g, are 0 - 28 days
 old, and are referred to the Unit of Reanimation and Neonatology of Hopital Gabriel Toure in
 Bamako, Mali, for inpatient care are eligible for enrollment in this two-year study. After
 informed parental consent is obtained, approximately 2 ml of venous blood will be collected
 for malaria diagnosis by OptiMal test, microscopy and polymerase chain reaction (PCR). If in
 the clinician's judgment drawing blood is not feasible, a small blood sample will be obtained
 by heel prick from the infants and tested for the presence of malaria parasites. If any of
 the three infant malaria tests is positive, parenteral quinine will be administered as per
 the National Malaria Control Program (NMCP) treatment guidelines. If malaria is detected in
 mothers, standard malaria therapy will be administered according to the National Malaria
 Control Program (NMCP) treatment guidelines. Blood will be obtained from mothers for
 molecular diagnosis of malaria infection and characterization of the genetic profile of
 mother's malaria infections.
Inclusion Criteria: Neonates: 1) Preterm born before 37 weeks of pregnancy admitted for
 inpatient care at HGT or Neonates aged between 0 - 28 days admitted for inpatient care at
 HGT 2) Admission weight more than 2000 grams 3) Parental informed consent obtained and
 signed for infant participation Criteria for Mothers: - Consenting mother of an enrolled
 infant Exclusion Criteria: Neonates: 1) Outpatient infant 2) Infant weighing less than
 2000g 3) Infants presenting the following symptoms of critical condition: bradycardy, gasp,
 severely altered general condition 4) Presence of severe anemia 5) Infants who are judged
 by the study physicians to be unfit for enrollment for any reason 6) Informed consent
 denied Criteria for Mothers: 1) Mothers with severe malaria (2) 2) Mothers with an acute
 severe disease 3) Mothers who are judged by the study physician to be unfit for enrollment
 for any reason 4) Informed consent denied