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Early Life Cohort in Papua Indonesia (ELIPI Study) (ELIPI)

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ClinicalTrials.gov Identifier: NCT02793336
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
Information provided by (Responsible Party):
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.


Condition or disease
Malaria

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : August 3, 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort
infant cohort
The study is designed as a continuation of a cohort of infants from 12 to 48 months of age. This follows on from two previous cohorts: "STOP MIP", which is a cohort of pregnant women followed up until delivery and the "Baby-Cohort study", which enrols babies from mothers in the "STOP MIP" trial and follows them until their first year of live. When participants of the "Baby-cohort Study" reach study end, they are offered to participate in this study.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study is designed as a continuation of a cohort of infants from 12 to 48 months of age. This follows on from two previous cohorts: "STOP MIP", which is a cohort of pregnant women followed up until delivery and the "Baby-Cohort study", which enrols babies from mothers in the "STOP MIP" trial and follows them until their first year of live. When participants of the "Baby-cohort Study" reach study end, they are offered to participate in this study.
Criteria

Inclusion Criteria:

  • Patient enrolled in the Baby-Cohort study

Exclusion Criteria:

  • Patients not enrolled in the Baby-Cohort study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793336


Contacts
Contact: Jeanne Rini Poespoprodjo, PhD +62811490738
Contact: Ric Price, PhD +618 89228197

Locations
Indonesia
Timika Research Facility Recruiting
Timika, Timika-Papua, Indonesia
Contact: Rini Poespoprodji         
Sponsors and Collaborators
Menzies School of Health Research
Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia

Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT02793336     History of Changes
Other Study ID Numbers: ELIPI
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided