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Clinical Trials/NCT02891746
NCT02891746
Withdrawn
Not Applicable

The Neonatal Microbiome and Its Influence on the Post-partum Period

Hadassah Medical Organization2 sites in 1 countrySeptember 7, 2016
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ConditionsMicrobiota

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Microbiota
Sponsor
Hadassah Medical Organization
Locations
2
Primary Endpoint
Definition the flora comprising the microbiome of premature and term babies
Status
Withdrawn
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2016
End Date
September 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Definition the flora comprising the microbiome of premature and term babies

Time Frame: birth

Secondary Outcomes

  • 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 Sites (2)

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