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Early Life Cohort in Papua Indonesia (ELIPI Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02793336
Acronym
ELIPI
Enrollment
500
Registered
2016-06-08
Start date
2016-08-03
Completion date
2024-03-12
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

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.

Interventions

None listed

Sponsors

Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
CollaboratorUNKNOWN
Menzies School of Health Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Patient enrolled in the Baby-Cohort study

Exclusion criteria

* Patients not enrolled in the Baby-Cohort study

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
severe anaemia (Hb<7g/dl) and/or blood transfusion4 yearsThe incidence risk of severe anaemia (Hb\<7g/dl) and/or the risk for blood transfusion
serious illnesses including hospitalization4 yearsThe incidence risk and rate of serious illnesses including hospitalization
non-malarial febrile episodes and bacterial co-infections4 yearsThe incidence risk and rate of non-malarial febrile episodes and bacterial co-infections
symptomatic P. vivax1 yearThe incidence rate of symptomatic P. vivax over 1 year in all participants
growth retardation and neurodevelopment delay4 yearsThe incidence risk of growth retardation and neurodevelopment delay
G6PD activity1 yearThe distribution of G6PD activity within the study population
Fluorescence spot test results (FST)1 yearThe change in FST result performed during the baby cohort study compared to the FST result performed at 12 months age
mortality4 yearsThe incidence risk of mortality

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026