Maternal and Neonatal Microbiome | NCT02891746

Studies
Maternal and Neonatal Microbiome

NCT02891746

Sponsor

Hadassah Medical Organization

Status

Withdrawn

Last Update Posted

Nov 28, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Microbiota

Interventions

non invasive sampling

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recent publications have made this study obsolete

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

May 31, 2016

First Submission Date that Met QC Criteria

Sep 1, 2016

First Posted Date

Sep 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2017

Last Update Posted Date

Nov 28, 2017Actual

Name	Class
Bar-Ilan University, Israel	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Premature infants		premature infants ≤ 34 weeks of gestation	Other: non invasive sampling
Term infants		neonates ≥ 37 weeks gestation	Other: non invasive sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non invasive sampling	Other		Premature infants Term infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Definition the flora comprising the microbiome of premature and term babies		birth

Secondary Outcomes

Measure	Description	Time Frame
Difference in the microbiome of the infants born vaginally and via caesarian section		birth
Change in the flora that constitutes the microbiome of premature babies		birth until adjusted age of 40 weeks gestation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

100 premature infants ≤ 34 weeks of gestation admitted to the Neonatal Intensive Care Unit and their mothers.

The control group :

100 neonates ≥ 37 weeks gestation of which 50 were delivered vaginally and 50 by Caesarean section and their mothers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization, Jerusalem, Israel		Jerusalem			Israel
Hadassah Medical Organization

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided