Child Follow-up Until 2 Years
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02800109|
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : May 24, 2017
The purpose of this study is to measure the impact of maternal malaria on child growth in the two first years of life in relation to fetal growth.
This study is following a birth cohort of children born to pregnant women enrolled in the study "Impact of malaria infection in pregnancy on fetal and newborn growth" (protocol OXTREC 14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2 years of age using routine anthropometric measurements such as weight, length, arm and head circumference. A few additional tests will enhance the sensitivity of the study outcomes with minimal risk. These tests will include anthropometry, screening, nutrition questionnaire and neurodevelopmental assessment.
|Condition or disease|
This is an existing on-going prospective birth cohort of children born to the pregnant women who had fetal growth assessed during pregnancy. In this cohort an expected 10% of pregnant women will be exposed to malaria while the remaining will be free of malaria. Their offspring are already followed up for growth monitoring from birth until 2 years of age with anthropometric measurements including weight, length, arm and head circumference at each scheduled visit. The investigator would like to enhance the sensitivity of the study outcomes with minimal risk for the child by proposing the following anthropometric and screening tests, nutrition questionnaire, and neurodevelopment assessment. In addition a prospective cohort of children born after study approval will be followed on both protocols. The additional measure include:
- Body fat composition (at birth, and monthly up to 4 months unless weight ≥ 8kg)
- Triceps and subscapular skinfold (at 1 and 2 years)
- Anemia, malaria and soil-transmitted helminths screening (every 3 months in first 12 months and 6-monthly 1-2 years)
- Buccal swab (at 1 and 2 years)
- Neurodevelopment (every 6 months)
- Food questionnaire (at 1 and 2 years)
|Study Type :||Observational|
|Estimated Enrollment :||1680 participants|
|Official Title:||Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth - Child Follow-up Until 2 Years of Age, in Relation to the Fetal Growth|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
- The proportion of children with sub-optimal growth by 2 years of age among children born to mother exposed to malaria and those born to mother non-exposed to malaria [ Time Frame: up to 2 years of age ]
- The median neurocognitive scores by growth groups and malaria-exposed groups [ Time Frame: up to 2 years of age ]
- The median age of onset of anemia by growth groups and malaria-exposed Groups [ Time Frame: up to 2 years of age ]
- Characterize of molecular signatures (methylation profile of the DNA) by growth groups and malaria-exposed groups [ Time Frame: up to 2 years of age ]
Biospecimen Retention: Samples With DNA
Biological samples will consist of a 50 uL of finger prick blood sample at month 3,6,9,12,18 and 24, and a stool sample.
A buccal swab will be collected at 1 and 2 years.
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): NCT02800109
|Contact: Verena Ilona Carrara, MDfirstname.lastname@example.org|
|Contact: Rose McGready, MD, PhDemail@example.com|
|Shoklo Malaria Research Unit||Recruiting|
|Mae Sot, Tak, Thailand, 63110|
|Contact: Verena Ilona Carrara, MD firstname.lastname@example.org|
|Contact: Rose McGready, MD,PhD email@example.com|