Development of Preterm Infant Gut Microbiome

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

Study Overview

• Status: Recruiting
• Conditions: Premature Infants
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Smadar Shilo, MD; Phone Number: +972-7774400; Email: smadar.shilo@weizmann.ac.il

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Department of Neonatology and Neonatal Intensive Carer unit Rambam medical center
    • Contact: Smadar Shilo, MD; Phone Number: 97247774400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature and term infants

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preterm infants; 100 preterm infants	Other: No intervention; No intervention
Term infants; 100 term healthy infants	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in gut microbial abundance over time	Preterm infants and full-term infants fecal DNA at different time points	One year

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: Weizmann Institute of Science

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 10, 2018
• First Posted (Actual): June 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 0490-17-RMB CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No