NCT03552952

Development of Preterm Infant Gut Microbiome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study aims to explore the developmental of the gut microbiome in preterm infants as they grow and mature

Detailed description

Preterm birth, defined as childbirth occurring at less than 37 completed weeks, is a major determinant of neonatal mortality and morbidity and has long-term adverse consequences for health. The human microbiome is the collective genome of the immense ecosystem of trillions of microbes and is considered to have a coevolved relationship with the immune system and fundamental roles in multiple aspects of human physiology. Little is known about the developmental of the gut microbiome in preterm infants as they grow and mature. One hundred premature infants born in Rambam healthcare campus in Haifa, Israel, will be recruited to the study and 100 term healthy infants will be recruited as controls. Infants born before 24 weeks of gestation or have birth weights of less than 400 g and infants with severe congenital anomalies will be excluded from the study. Fecal samples will be collected during the hospital stay and in follow-up visits. Blood samples will be taken during the hospital stay. The investigators will analyze the data from this clinical cohort using computational and experimental approaches for extracting novel information on microbiome composition and development, gene function, metabolic pathways and metabolite production.

Conditions

• Premature Infants

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2018-03-08
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2018-06-12
• Last updated: 2020-07-22

Locations

1 site across 1 country: Israel