Maternal and Neonatal Microbiome

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02891746
• Other study ID #: Mat-Neo-Micro-HMO-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: May 31, 2016
• Last updated: November 26, 2017
• Est. completion date: September 2020

Study information

• Verified date: July 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Microbiota

Intervention

Other:
• non invasive sampling

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definition the flora comprising the microbiome of premature and term babies		birth
Secondary	Difference in the microbiome of the infants born vaginally and via caesarian section		birth
Secondary	Change in the flora that constitutes the microbiome of premature babies		birth until adjusted age of 40 weeks gestation