Skip to main content
OpenTrials
Completed

NCT Number: NCT02793336

Early Life Cohort in Papua Indonesia (ELIPI Study)

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Timika Research Facility

Timika, Timika-Papua, Indonesia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient enrolled in the Baby-Cohort study

Exclusion criteria

  • Patients not enrolled in the Baby-Cohort study

Treatment and study plan

Primary outcomes

  1. 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

  1. symptomatic P. vivax

    Time frame: 1 year

    The incidence rate of symptomatic P. vivax over 1 year in all participants

  2. severe anaemia (Hb<7g/dl) and/or blood transfusion

    Time frame: 4 years

    The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion

  3. serious illnesses including hospitalization

    Time frame: 4 years

    The incidence risk and rate of serious illnesses including hospitalization

  4. non-malarial febrile episodes and bacterial co-infections

    Time frame: 4 years

    The incidence risk and rate of non-malarial febrile episodes and bacterial co-infections

  5. mortality

    Time frame: 4 years

    The incidence risk of mortality

  6. growth retardation and neurodevelopment delay

    Time frame: 4 years

    The incidence risk of growth retardation and neurodevelopment delay

  7. G6PD activity

    Time frame: 1 year

    The distribution of G6PD activity within the study population

  8. Fluorescence spot test results (FST)

    Time frame: 1 year

    The change in FST result performed during the baby cohort study compared to the FST result performed at 12 months age

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

  • Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia

Registry information

Acronym: ELIPI

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2016
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.