NCT02891746WithdrawnNot Applicable
The Neonatal Microbiome and Its Influence on the Post-partum Period
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Definition the flora comprising the microbiome of premature and term babies
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Dynamics of the Microbiome in the Premature InfantInfectionNCT02121938Duke University30
Completed
Not Applicable
Defining the Intestinal Microbiota in Premature NeonatesPremature Intestinal MicrobiotaLate Onset Bloodstream InfectionNecrotizing EnterocolitisNCT01102738Imperial College London369
Completed
Not Applicable
Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of ProbioticsGut MicrobiotaNCT04994834Chr Hansen22
Completed
Not Applicable
Association of Gut Microbiome With Neonatal Complications and Neurodevelopment in Preterm InfantsPreterm InfantsNCT03841994Seoul National University Hospital47
Recruiting
Not Applicable
Development of Preterm Infant Gut MicrobiomePremature InfantsNCT03552952Rambam Health Care Campus200