Maternal and Neonatal Microbiome

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Microbiota
• Intervention / Treatment: Other: non invasive sampling

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization
  • Jerusalem, Israel
    • Hadassah Medical Organization, Jerusalem, Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Definition the flora comprising the microbiome of premature and term babies	birth

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Bar-Ilan University, Israel

Study record dates

Study Major Dates

• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: September 1, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: Mat-Neo-Micro-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED