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NCT03104673: MSP_Ext

Molecular Signature Children

Completed Last updated 21 June 2021
What this trial tests

trial in Preterm Birth in 384 participants. Completed in 28 January 2021.

Timeline
30 April 2017
Primary endpoint
28 January 2021
28 January 2021

Quick facts

Lead sponsorUniversity of Oxford
StatusCompleted
Study typeOBSERVATIONAL
Enrollment384
Start date30 April 2017
Primary completion28 January 2021
Estimated completion28 January 2021
Sites1 location across Thailand

Conditions studied

Sponsor

University of Oxford

Who can join

Eligibility, any sex, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Preterm Birth

Currently open trials in the same condition.

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Data sources for this page

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