Skip to main content
Clinical Trials/NCT02793336
NCT02793336
Completed
Not Applicable

Early Life Cohort in Papua Indonesia (ELIPI Study)

Menzies School of Health Research1 site in 1 country500 target enrollmentAugust 3, 2016
ConditionsMalaria

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malaria
Sponsor
Menzies School of Health Research
Enrollment
500
Locations
1
Primary Endpoint
P. vivax parasitaemia (PCR or microscopy)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Malaria remains an important cause of illness in young infants. Our clinical and epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in infants in the first 5 years of life, including recurrent episodes of malaria, anaemia, malnutrition and coinfection. Together these contribute significantly morbidity in early life, and almost certainly to the very high infant mortality rates in this region. However the body of knowledge around infant malaria outside of Africa, where both species P. vivax and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax malaria and severe anaemia on neurodevelopment and growth in young children is unknown in Papua.

This study therefore aims to provide longitudinal data on the incidence of symptomatic and asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It also provides an opportunity to assess incidence risk of non-malaria febrile illnesses and bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth in a vulnerable age group. The study is a continuation from two already established cohort studies: "STOP MIP", which enrolled pregnant women and followed them until delivery and a "baby-cohort", which enrolled babies from mothers included in the cohort and followed them through their first year of life. Continuous follow up of those babies until they are 4 years old will increase our understanding of long term impact especially of vivax malaria. The cohort will be linked to a randomized controlled trial (RCT) and will offer cohort patients to be enrolled into the RCT when they are diagnosed with malaria (symptomatic), allowing to estimate treatment effectiveness.

Registry
clinicaltrials.gov
Start Date
August 3, 2016
End Date
March 12, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient enrolled in the Baby-Cohort study

Exclusion Criteria

  • Patients not enrolled in the Baby-Cohort study

Outcomes

Primary Outcomes

P. vivax parasitaemia (PCR or microscopy)

Time Frame: 1 year

The incidence rate of any P. vivax parasitaemia (PCR or microscopy) over 1 year in all infants

Secondary Outcomes

  • symptomatic P. vivax(1 year)
  • severe anaemia (Hb<7g/dl) and/or blood transfusion(4 years)
  • serious illnesses including hospitalization(4 years)
  • non-malarial febrile episodes and bacterial co-infections(4 years)
  • Fluorescence spot test results (FST)(1 year)
  • mortality(4 years)
  • growth retardation and neurodevelopment delay(4 years)
  • G6PD activity(1 year)

Study Sites (1)

Loading locations...

Similar Trials