Congenital and Neonatal Malaria in Mali

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00384267
First received: October 4, 2006
Last updated: November 10, 2011
Last verified: September 2008
  Purpose

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
Malaria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Congenital and Neonatal Malaria in Mali

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • # of neonates with malaria infection [ Time Frame: Immediately upon entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of acquired malaria [ Time Frame: Immediately upon entry ] [ Designated as safety issue: No ]
  • Prevalence of antimalarial antibodies in neonates [ Time Frame: Immediately upon entry ] [ Designated as safety issue: No ]
  • The rate of congenital malaria [ Time Frame: Immediately upon entry ] [ Designated as safety issue: No ]
  • Prevalence of specific hemoglobin types in study population [ Time Frame: Immediately upon entry ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 44
Study Start Date: October 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Neonates
Inpatient

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A cross-sectional analysis of 300 inpatient 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, Bamako, Mali

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384267

Locations
Mali
Hopital Gabriel Toure
Bamako, Mali
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Director ORA, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00384267     History of Changes
Other Study ID Numbers: 05-0119
Study First Received: October 4, 2006
Last Updated: November 10, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
malaria, infants, preterm babies, neonates, Mali

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 23, 2014