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NCT03104673

Molecular Signature Children

Sponsor: University of Oxford

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

380

Start Date

2017-04-30

Completion Date

2021-02-12

Last Updated

2026-09-02

Healthy Volunteers

Yes

Conditions

Locations (1)

Shoklo Malaria Research Unit

Tak, Mae Sot, Thailand