Congenital and Neonatal Malaria in Mali

Malaria Clinical Trial

Official title:

Congenital and Neonatal Malaria in Mali

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384267
• Other study ID #: 05-0119
• Status: Completed
• Phase: N/A
• First received: October 4, 2006
• Last updated: November 10, 2011
• Start date: October 2006
• Est. completion date: April 2009

Study information

• Verified date: September 2008
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria

Locations

Country	Name	City	State
Mali	Hopital Gabriel Toure	Bamako

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	# of neonates with malaria infection		Immediately upon entry	No
Secondary	The rate of acquired malaria		Immediately upon entry	No
Secondary	Prevalence of antimalarial antibodies in neonates		Immediately upon entry	No
Secondary	The rate of congenital malaria		Immediately upon entry	No
Secondary	Prevalence of specific hemoglobin types in study population		Immediately upon entry	No