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Maternal and Neonatal Microbiome

NCT ID: NCT02891746

Last Updated: 2017-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Completion Date

2020-09-30

Brief Summary

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The aim of the study is to characterize and monitor the microbiome of premature infants born in the investigators facility until discharge from the NICU. The investigators will also examine the relationship between mode of delivery and the microbiome of the infant, while exploring various possible factors that may affect it. In addition, the investigators will compare the microbiome of premature infants to the microbiome of term babies born at the same time in the same facility.

Detailed Description

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Conditions

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Microbiota

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Premature infants

premature infants ≤ 34 weeks of gestation

non invasive sampling

Intervention Type OTHER

Term infants

neonates ≥ 37 weeks gestation

non invasive sampling

Intervention Type OTHER

Interventions

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non invasive sampling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Premature infants ≤ 34 weeks of gestation admitted to the Neonatal Intensive Care Unit at Hadassah University Hospital, Mount Scopus and their mothers.

The control group:

* Neonates ≥ 37 weeks gestation of which 50 were delivered vaginally and 50 by Caesarean section at Hadassah University Hospital, Mount Scopus and their mothers.

Exclusion Criteria

* Neonates with congenital anomalies or metabolic conditions.
Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bar-Ilan University, Israel

OTHER

Sponsor Role collaborator

Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Mat-Neo-Micro-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id