Child Follow-up Until 2 Years

NCT02800109 | Completed

• 1 other identifier: SMRU1504
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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. This study was funded by Wellcome Trust core funding, grant ref. number Wellcome Trust Major Overseas Program Grant no. 220211 (2020-2025)

Conditions

Malaria; Pregnancy

Keywords

Fetal growth; Newborn growth

Outcome Measures

Primary Outcomes (1)

• 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

  up to 2 years of age

Secondary Outcomes (3)

• The median neurocognitive scores by growth groups and malaria-exposed groups

  up to 2 years of age

• The median age of onset of anemia by growth groups and malaria-exposed Groups

  up to 2 years of age

• Characterize of molecular signatures (methylation profile of the DNA) by growth groups and malaria-exposed groups

  up to 2 years of age

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Participants in a current birth cohort. For those pregnant women who have not yet delivered (circa n=25), permission for their unborn child to commence participation after delivery will be conducted after ethical approval has been received. For those children who have already been born in the existing birth cohort and less than 2 years of age an invitation to participate will be proposed to the parent or legal guardian after ethical approval has been granted.

You may qualify if:

• Participant's parent or legal guardian is willing and able to give informed consent for participation in the study
• Able (in the Investigators opinion) to comply with study requirements

You may not qualify if:

• The participant may not enter the study if ANY of the following apply:
• Medical or congenital complications which would (in the investigator's opinion) make it difficult to comply with study requirements
• Aged older than 2 years

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

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.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 15, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)