Early Life Cohort in Papua Indonesia (ELIPI Study)

Completed

• Conditions: Malaria

• Registration Number: NCT02793336
• Lead Sponsor: Menzies School of Health Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Study Start: 2016-08-03
• Status Verified: 2024-03
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patient enrolled in the Baby-Cohort study

Read More

Exclusion Criteria

• Patients not enrolled in the Baby-Cohort study

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
symptomatic P. vivax	1 year	The incidence rate of symptomatic P. vivax over 1 year in all participants
severe anaemia (Hb<7g/dl) and/or blood transfusion	4 years	The incidence risk of severe anaemia (Hb\<7g/dl) and/or the risk for blood transfusion
serious illnesses including hospitalization	4 years	The incidence risk and rate of serious illnesses including hospitalization
non-malarial febrile episodes and bacterial co-infections	4 years	The incidence risk and rate of non-malarial febrile episodes and bacterial co-infections
Fluorescence spot test results (FST)	1 year	The change in FST result performed during the baby cohort study compared to the FST result performed at 12 months age
mortality	4 years	The incidence risk of mortality
growth retardation and neurodevelopment delay	4 years	The incidence risk of growth retardation and neurodevelopment delay
G6PD activity	1 year	The distribution of G6PD activity within the study population

Trial Locations

Locations (1)

Timika Research Facility; 🇮🇩 Timika, Timika-Papua, Indonesia