NCT00138489

Brief Summary

The purpose of this study is to learn more about vivax malaria in very young children, how the growth of children is affected by malaria infections, and how inherited traits protect children from getting malaria. Participants will be 266 children 24 months of age or younger who live in certain villages in East Sepik Province, Papua New Guinea, where malaria is very common. The study also will find out how malaria spreads in the area. By learning how and when a child develops resistance to vivax malaria, researchers can try to find ways to help people from getting it. And, they can get a better understanding of how inherited traits influence all types of malaria infections. In this study, the parent and child will be visited by the study team or health workers every week to check health and bednet use. Every 2 weeks, the study team will take a small blood sample to check for malaria and take measurements to study the child's growth. Participants will be followed for up to 2 years.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 10, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

February 4, 2019

Status Verified

October 1, 2007

First QC Date

August 26, 2005

Last Update Submit

January 31, 2019

Conditions

Keywords

Malaria, Papua New Guinea, infants, children

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \< = 12 months of age at the time of eligibility assessment Residence in a designated study village Parental / legal guardian consent
  • Participants who move outside the study area during the course of the study will be dropped from further participation. However, data collected to that point may be included in statistical analyses. Parental consent to study is essential. No blood samples or measurements will be taken on a child without informed consent.

You may not qualify if:

  • \> 12 months of age at the time of eligibility assessment Chronic illness, severe malnutrition, permanent disability, or a congenital malformation that prevents or impedes study participation Short-term, temporary residence (less than 6 months) in a designated study village Residence in a village outside of the study area Parental refusal to consent to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papua New Guinea Institute of Medical Research

Goroka, EHP 441, Papua New Guinea

Location

MeSH Terms

Conditions

Malaria, VivaxMalaria

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

August 26, 2005

First Posted

August 30, 2005

Study Start

February 10, 2004

Last Updated

February 4, 2019

Record last verified: 2007-10

Locations