Ignite Creation Date:
2024-05-06 @ 8:40 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02793336
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2016-05-26
Brief Title:
Early Life Cohort in Papua Indonesia ELIPI Study
Sponsor:
Menzies School of Health Research
Organization:
Menzies School of Health Research
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELIPI
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None