Exploring gut microbiome development in preterm infants
Development of Preterm Infant Gut Microbiome
Rambam Health Care Campus · NCT03552952
This study looks at how the gut bacteria in preterm babies develop as they grow to see how it affects their health compared to full-term babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Rambam Health Care Campus (other) |
| Locations | 1 site (Haifa) |
| Trial ID | NCT03552952 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the development of the gut microbiome in preterm infants as they grow and mature. It will recruit 100 premature infants and 100 healthy term infants as controls at Rambam Healthcare Campus in Haifa, Israel. Fecal and blood samples will be collected during hospital stays and follow-up visits to analyze microbiome composition, gene function, and metabolic pathways. The study aims to provide insights into the relationship between gut microbiome development and health outcomes in preterm infants.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants born at Rambam Healthcare Campus.
Not a fit: Patients born before 24 weeks of gestation, with birth weights under 400 g, or with severe congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of gut microbiome development in preterm infants, potentially leading to improved health outcomes.
How similar studies have performed: While there is limited research specifically on preterm infant gut microbiome development, studies on microbiome impacts in other populations have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature and term infants born in Rambam healthcare campus in Haifa, Israel Exclusion Criteria: * 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.
Where this trial is running
Haifa
- Department of Neonatology and Neonatal Intensive Carer unit Rambam medical center — Haifa, Israel (RECRUITING)
Study contacts
- Study coordinator: Smadar Shilo, MD
- Email: smadar.shilo@weizmann.ac.il
- Phone: +972-7774400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Infants