Molecular Signature Children (MSP_Ext)
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|ClinicalTrials.gov Identifier: NCT03104673|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : August 13, 2018
Preterm birth (PTB) occurs before 37 weeks of gestation and is a major cause of neonatal mortality and morbidity. PTB results from heterogeneous influences. One of them is the inherited predisposition of spontaneous PTB, and another is the change in the placental microbial composition as this can cause infections, which lead to inflammation, a common cause of preterm birth. Interestingly, maternal periodontal disease is an independent risk factor for PTB, low birth weight and fetal growth restriction. Immune responses to infectious events or inflammation as well as genetic predisposition to inherited conditions have successfully been studied by using assessing genetic expression profiling. The molecular signature is sets of genes, proteins, genetic variants or other variables that can be used as markers for a particular phenotype.
Child morbidity from malnutrition resulting in poor growth and stunting remains a major public health issue that affects the local population just like PTB. While risk factors for malnutrition are multifaceted, there is also a hypothesized causal link between early gut microbiome disruption that leads to chronic malnutrition in otherwise healthy infants.
Molecular signatures including the intestinal microbiome development of preterm infants will be evaluated and compared to the term (≥37 weeks' gestation) counterparts. Moreover, a comprehensive examination of possible factors associated with poor growth and poor motor- and neurodevelopment will be assessed.
In this extension study: The primary goal for the child is to evaluate the perturbation in the development of the genomic profile including intestinal microbial habitat from children in a rural and limited-resource setting from birth to two years of life.
|Condition or disease|
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|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Molecular Signature of Karen and Burmese Children Until Two Years of Age on the Thailand--Myanmar Border: a Study Extension of TMEC 15-062|
|Actual Study Start Date :||April 30, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
- Characterization of the molecular signature of child [ Time Frame: at birth ]Early childhood Transcriptome from capillary blood
- Characterization of the molecular signature of child [ Time Frame: 1 year ]Early childhood Transcriptome from capillary blood
- Characterization of the molecular signature of child [ Time Frame: 2 years ]Early childhood Transcriptome from capillary blood
- Proportions of nutrition and water, sanitation and hygiene (WASH) behaviours in home-based compared to clinic-based care [ Time Frame: 9 months ]
- Proportion of children with biomarkers perturbations associated with poor child growth [ Time Frame: From birth to two years of life. ]Describe the biomarkers predictive
- Proportion of children with biomarkers perturbations associated with neurocognitive and motor development [ Time Frame: From birth to two years of life. ]Describe the biomarkers predictive
- Proportion of children with biomarkers perturbations associated with anaemia [ Time Frame: From birth to two years of life. ]Describe the biomarkers predictive
- Association between nutrition and water, sanitation and hygiene (WASH) behaviours and biomarker signature perturbations in children [ Time Frame: 9 months ]
Biospecimen Retention: Samples With DNA
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): NCT03104673
|Contact: Rose McGready, MD, PhD||+(66) email@example.com|
|Contact: Francois Nosten, MD, PhD||+(66) firstname.lastname@example.org|
|Shoklo Malaria Research Unit||Recruiting|
|Tak, Mae Sot, Thailand, 63110|
|Contact: Rose McGready, MD +6655-545-021 email@example.com|
|Principal Investigator: Rose McGready, MD|