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Child Follow-up Until 2 Years

This study is currently recruiting participants.
Verified May 2017 by University of Oxford
Sponsor:
ClinicalTrials.gov Identifier:
NCT02800109
First Posted: June 15, 2016
Last Update Posted: May 24, 2017
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.
Information provided by (Responsible Party):
University of Oxford
  Purpose

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
Malaria Pregnancy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 1680
Actual Study Start Date: May 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
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)
  Eligibility

Information from the National Library of Medicine

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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
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): NCT02800109


Contacts
Contact: Verena Ilona Carrara, MD verena@shoklo-unit.com
Contact: Rose McGready, MD, PhD rose@shoklo-unit.com

Locations
Thailand
Shoklo Malaria Research Unit Recruiting
Mae Sot, Tak, Thailand, 63110
Contact: Verena Ilona Carrara, MD       verena@shoklo-unit.com   
Contact: Rose McGready, MD,PhD       rose@shoklo-unit.com   
Sponsors and Collaborators
University of Oxford
  More Information

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02800109     History of Changes
Other Study ID Numbers: SMRU1504
First Submitted: May 27, 2016
First Posted: June 15, 2016
Last Update Posted: May 24, 2017
Last Verified: May 2017
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