Congenital and Neonatal Malaria in Mali

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00384267
Collaborator
(none)
44
1
30
1.5

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    44 participants
    Time Perspective:
    Prospective
    Official Title:
    Congenital and Neonatal Malaria in Mali
    Study Start Date :
    Oct 1, 2006
    Actual Primary Completion Date :
    Apr 1, 2009
    Actual Study Completion Date :
    Apr 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Neonates

    Inpatient

    Outcome Measures

    Primary Outcome Measures

    1. # of neonates with malaria infection [Immediately upon entry]

    Secondary Outcome Measures

    1. The rate of acquired malaria [Immediately upon entry]

    2. Prevalence of antimalarial antibodies in neonates [Immediately upon entry]

    3. The rate of congenital malaria [Immediately upon entry]

    4. Prevalence of specific hemoglobin types in study population [Immediately upon entry]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Gabriel Toure Bamako Mali

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00384267
    Other Study ID Numbers:
    • 05-0119
    First Posted:
    Oct 6, 2006
    Last Update Posted:
    Nov 11, 2011
    Last Verified:
    Sep 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 11, 2011