NCT00384267

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

November 11, 2011

Status Verified

September 1, 2008

Enrollment Period

2.5 years

First QC Date

October 4, 2006

Last Update Submit

November 10, 2011

Conditions

Malaria

Keywords

malaria, infants, preterm babies, neonates, Mali

Outcome Measures

Primary Outcomes (1)

  • # of neonates with malaria infection

    Immediately upon entry

Secondary Outcomes (4)

  • The rate of acquired malaria

    Immediately upon entry

  • Prevalence of antimalarial antibodies in neonates

    Immediately upon entry

  • The rate of congenital malaria

    Immediately upon entry

  • Prevalence of specific hemoglobin types in study population

    Immediately upon entry

Study Arms (1)

Neonates

Inpatient

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Gabriel Toure

Bamako, Mali

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

October 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

November 11, 2011

Record last verified: 2008-09

Locations

MA(1)