Maternal and Neonatal Microbiome

Withdrawn

• Conditions: Microbiota
• Interventions: Other: non invasive sampling

• Registration Number: NCT02891746
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-07
• Status Verified: 2017-07
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28
• Primary Completion: 2019-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Term infants	non invasive sampling	neonates ≥ 37 weeks gestation
Premature infants	non invasive sampling	premature infants ≤ 34 weeks of gestation

Primary Outcome Measures

Name	Time	Method
Definition the flora comprising the microbiome of premature and term babies	birth

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel