NCT03552952

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

7.3 years

First QC Date

May 22, 2018

Last Update Submit

July 19, 2020

Conditions

Premature Infants

Outcome Measures

Primary Outcomes (1)

  • Changes in gut microbial abundance over time

    Preterm infants and full-term infants fecal DNA at different time points

    One year

Study Arms (2)

Preterm infants

100 preterm infants

Other: No intervention

Term infants

100 term healthy infants

Other: No intervention

Interventions

No interventionOTHER

No intervention

Preterm infantsTerm infants

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Premature and term infants

You may qualify if:

  • Premature and term infants born in Rambam healthcare campus in Haifa, Israel

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology and Neonatal Intensive Carer unit Rambam medical center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Smadar Shilo, MD

CONTACT

+972-7774400smadar.shilo@weizmann.ac.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 12, 2018

Study Start

March 8, 2018

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

IL(1)