NCT02891746

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 28, 2017

Status Verified

July 1, 2017

First QC Date

May 31, 2016

Last Update Submit

November 26, 2017

Conditions

Microbiota

Outcome Measures

Primary Outcomes (1)

  • Definition the flora comprising the microbiome of premature and term babies

    birth

Secondary Outcomes (2)

  • 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

Study Arms (2)

Premature infants

premature infants ≤ 34 weeks of gestation

Other: non invasive sampling

Term infants

neonates ≥ 37 weeks gestation

Other: non invasive sampling

Interventions

non invasive samplingOTHER
Premature infantsTerm infants

Eligibility Criteria

AgeUp to 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Neonates with congenital anomalies or metabolic conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

Hadassah Medical Organization

Jerusalem, Israel

Location
0

Study Design

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

Study Record Dates

First Submitted

May 31, 2016

First Posted

September 7, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

November 28, 2017

Record last verified: 2017-07

Locations

IL(2)