MalariaNCT02800109
Child Follow-up Until 2 Years
An observational study of Malaria and Pregnancy, run by University of Oxford at 1 site in Thailand.
Trial 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"… Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- How many people
- 201 participants
- Where
- 1 siteThailand
- Study dates
- May 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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)
Summary of results:
The beginning of the recruitment was delayed until the finalization and approval of the translated PIS/ICF; from then on, the recruitment was smooth. Overall, 201 children from the ongoing existing birth cohort were still present and eligible to participate in this part of the study; 173 completed 2 years of FUP 28 were lost. Data and samples from these 173 children were included in the analysis of a large, multi-center, study, the INTERBIO-21st.
The pooled findings show 1. Cognitive development, language, and visual skills at 2 years of age vary according to the trajectories of fetal cranial growth 2. There is a critical window period at 20-25 weeks gestational age when fetal cranial trajectories may diverge and when fetal abdominal circumference growth may accelerate or decelerate 3. Preterm newborn's growth and neurocognitive development vary according to their birth phenotype characteristics (i.e. those classified in the "birth infections" phenotype were at higher risk for poor scoring in fine and gross motor development compared to term newborns) 4. An indication of a greater increase in weight in proportion to height during the 2 first years of life if there was a faltering growth phenotype observed during gestation.
Maternal malaria and anemia's role in the development of children were evaluated specifically for this study site and included all the children followed up to one year of age. Preliminary results show that 48% of children are stunted at 2 years of age and that malaria and anemia independently are significant contributors to the decline in growth z-scores during infancy (manuscript in preparation); that 66% of children have anemia (HCT<33%) in the first year of life, the median age for a first HCT<33% is 4 months of age and that moderate, but not mild anemia in infancy reduces the median neurodevelopment score at year of age. Maternal anemia but not malaria is a factor contributing to increased risk of anemia in infants. Results were presented at local and regional and international conferences and were part of a MSc thesis.
- Keywords
- Fetal growth, Newborn growth
- Medical subject headings
- Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 years of age
Secondary outcomes (3)
The median neurocognitive scores by growth groups and malaria-exposed groups
Measured: up to 2 years of age
The median age of onset of anemia by growth groups and malaria-exposed Groups
Measured: up to 2 years of age
Characterize of molecular signatures (methylation profile of the DNA) by growth groups and malaria-exposed groups
Measured: up to 2 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800109
- Sponsor's protocol ID
- SMRU1504
- Status last verified
- Feb 2024
- First submitted
- 27 May 2016
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02800109
- Acronym / sponsor ID
- SMRU1504
- Keywords
- Fetal growth, Newborn growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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)
Summary of results:
The beginning of the recruitment was delayed until the finalization and approval of the translated PIS/ICF; from then on, the recruitment was smooth. Overall, 201 children from the ongoing existing birth cohort were still present and eligible to participate in this part of the study; 173 completed 2 years of FUP 28 were lost. Data and samples from these 173 children were included in the analysis of a large, multi-center, study, the INTERBIO-21st.
The pooled findings show 1. Cognitive development, language, and visual skills at 2 years of age vary according to the trajectories of fetal cranial growth 2. There is a critical window period at 20-25 weeks gestational age when fetal cranial trajectories may diverge and when fetal abdominal circumference growth may accelerate or decelerate 3. Preterm newborn's growth and neurocognitive development vary according to their birth phenotype characteristics (i.e. those classified in the "birth infections" phenotype were at higher risk for poor scoring in fine and gross motor development compared to term newborns) 4. An indication of a greater increase in weight in proportion to height during the 2 first years of life if there was a faltering growth phenotype observed during gestation.
Maternal malaria and anemia's role in the development of children were evaluated specifically for this study site and included all the children followed up to one year of age. Preliminary results show that 48% of children are stunted at 2 years of age and that malaria and anemia independently are significant contributors to the decline in growth z-scores during infancy (manuscript in preparation); that 66% of children have anemia (HCT<33%) in the first year of life, the median age for a first HCT<33% is 4 months of age and that moderate, but not mild anemia in infancy reduces the median neurodevelopment score at year of age. Maternal anemia but not malaria is a factor contributing to increased risk of anemia in infants. Results were presented at local and regional and international conferences and were part of a MSc thesis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Medical or congenital complications which would (in the investigator's opinion) make it difficult to comply with study requirements
- Aged older than 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Pregnancy, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.