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Maternal and Neonatal Microbiome

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ClinicalTrials.gov Identifier: NCT02891746
Recruitment Status : Withdrawn (recent publications have made this study obsolete)
First Posted : September 7, 2016
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
Bar-Ilan University, Israel
Information provided by (Responsible Party):
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment
Microbiota Other: non invasive sampling

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Neonatal Microbiome and Its Influence on the Post-partum Period
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Group/Cohort Intervention/treatment
Premature infants
premature infants ≤ 34 weeks of gestation
Other: non invasive sampling
Term infants
neonates ≥ 37 weeks gestation
Other: non invasive sampling



Primary Outcome Measures :
  1. Definition the flora comprising the microbiome of premature and term babies [ Time Frame: birth ]

Secondary Outcome Measures :
  1. Difference in the microbiome of the infants born vaginally and via caesarian section [ Time Frame: birth ]
  2. Change in the flora that constitutes the microbiome of premature babies [ Time Frame: birth until adjusted age of 40 weeks gestation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891746


Locations
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Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Bar-Ilan University, Israel
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Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02891746    
Other Study ID Numbers: Mat-Neo-Micro-HMO-CTIL
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided