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NCT03104673: MSP_Ext
Molecular Signature Children
trial in Preterm Birth in 384 participants. Completed in 28 January 2021.
28 January 2021
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 384 |
| Start date | 30 April 2017 |
| Primary completion | 28 January 2021 |
| Estimated completion | 28 January 2021 |
| Sites | 1 location across Thailand |
Conditions studied
- Preterm Birth — all drugs for Preterm Birth →
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.
Verify or expand the search:
- PubMed search for NCT03104673
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other University of Oxford trials
Trials by the same sponsor.
- NCT05380388 — A Safety, Immunogenicity and Efficacy Study of PvRII/Matrix-M in Healthy Thai Adults Living in Thailand ( MIST3 ) · Phase 2 · not yet recruiting
- NCT07470424 — A Clinical Study of Piperaquine, Pyronaridine, and Artesunate Administered in Combination in Healthy Adults · Phase 1 · not yet recruiting
- NCT07345910 — Environment, Pathogens, and Host Interactions in Melioidosis · not yet recruiting
- NCT07434973 — Stratification and Treatment in Early Psychosis Study - PROMOTE · Phase 3 · not yet recruiting
- NCT07460401 — 'Do Patient Characteristics Associate With Poor Outcome With Femoral Acetabular Impingement Syndrome (FAIS) Following Ph · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03104673 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oxford
- Last refreshed: 21 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03104673.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing