N/A
N=369
Defining the Intestinal Microbiota in Premature Neonates
Premature Intestinal Microbiota · Necrotizing Enterocolitis · Late Onset Bloodstream Infection
Bottom Line
View on ClinicalTrials.gov: NCT01102738 ↗Enrolled (actual)
369
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: The Composition of Bacteria Present, Established by Ultra-deep RNA Gene Sequencing, in Pre-morbid Faecal Samples From Neonates With Necrotizing Enterocolitis and Late-onset Bacterial Sepsis. — 7; 4; 1; 36 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Composition of Bacteria Present, Established by Ultra-deep RNA Gene Sequencing, in Pre-morbid Faecal Samples From Neonates With Necrotizing Enterocolitis and Late-onset Bacterial Sepsis. |
7; 4; 1; 36 | — |
Summary
The investigators will collect daily faecal samples from premature (<32 weeks) infants in the intensive care unit from the day of birth until they are discharged. By using newly developed molecular detection techniques the investigators aim to define more precisely than has ever previously been attempted, all the species of bacteria present in the faeces. This will enable comparison of the pre-morbid and post-morbid intestinal microbiota (all the bacteria in the gut) in premature neonates.
Eligibility Criteria
Inclusion Criteria
- All premature babies born at less than 32 completed weeks gestation who are admitted to an Imperial College NHS Healthcare Trust Neonatal Intensive Care Unit (St. Mary's Hospital or Queen Charlotte's & Chelsea Hospital), and whose parents/guardians have given their consent will be eligible to enter the study.
Exclusion Criteria
- All babies born at more than 32 completed weeks gestation will be excluded from the study.
Data sourced from ClinicalTrials.gov (NCT01102738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.