Child Follow-up Until 2 Years

• ClinicalTrials.gov Identifier: NCT02800109
• Recruitment Status: Completed
• First Posted: June 15, 2016
• Last Update Posted: January 8, 2019
• Sponsor: University of Oxford
• Information provided by (Responsible Party): University of Oxford

Study Description

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.

Condition or disease
Malaria; Pregnancy

Detailed Description:

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 Design

• Study Type: Observational
• Actual Enrollment: 201 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Primary Completion Date: February 2018
• Actual Study Completion Date: February 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: up to 2 years of age ]

Secondary Outcome Measures :

1. The median neurocognitive scores by growth groups and malaria-exposed groups [ Time Frame: up to 2 years of age ]
2. The median age of onset of anemia by growth groups and malaria-exposed Groups [ Time Frame: up to 2 years of age ]
3. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 2 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

Locations

Thailand

Shoklo Malaria Research Unit

Mae Sot, Tak, Thailand, 63110

Sponsors and Collaborators

University of Oxford

More Information

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT02800109
• Other Study ID Numbers: SMRU1504
• First Posted: June 15, 2016
• Last Update Posted: January 8, 2019
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by University of Oxford:

Fetal growth; Newborn growth

Additional relevant MeSH terms:

Malaria; Protozoan Infections; Parasitic Diseases