Defining the Intestinal Microbiota in Premature Neonates

The Microbiota of the Premature Neonatal Gastrointestinal Tract: Its Development and Relation to Necrotizing Enterocolitis and Bloodstream Infection

Sponsors

Lead Sponsor: Imperial College London

Collaborator: The Winnicott Foundation
National Heart and Lung Institute
Chelsea and Westminster NHS Foundation Trust

Source Imperial College London
Brief 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.

Detailed Description

Highly premature infants are susceptible to serious infections such as necrotizing enterocolitis (NEC) and late-onset blood stream infections (BSIs).

NEC is a poorly understood, potentially life-threatening bowel disorder. It is thought that bacteria proliferating abnormally in the bowel may play an important part in its cause, but no single pathogen has yet been identified.

BSIs are commonly caused by gut bacteria. As the highly premature gut is fragile and has increased permeability, poor motility and decreased immune defences, localised inflammation caused by abnormal bacterial growth may allow 'bystander' microbes to translocate through the gut into the blood stream leading to systemic infection.

In a small proportion of infants who develop NEC, surgery will be required as part of treatment of the condition. In these infants the investigators will seek consent to collect a small part of the diseased bowel which has been removed. Similar analysis will be performed on these samples. The analysis of the tissue samples will give us an indication of how well the faeces act as a proxy for the intestinal microbiota.

In this ecological study of the evolution of the intestinal microbiota in preterm infants, by comparing samples from babies who develop NEC or late-onset BSI with those of well babies the investigators will be able to look for differences characteristic of the conditions. This information will help aid design of prevention or treatment strategies.

Overall Status Completed
Start Date January 2011
Completion Date June 2014
Primary Completion Date January 2013
Study Type Observational
Primary Outcome
Measure Time Frame
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. Maximum of 6 months - serial samples collected from each infant (maximum admission duration 6 months), recruitment opened for 24 months.
Enrollment 369
Condition
Eligibility

Sampling Method: Non-Probability Sample

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.

Gender: All

Minimum Age: N/A

Maximum Age: 32 Weeks

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
J Simon Kroll, MA BM FRCP Principal Investigator Imperial College London
Location
Facility:
Imperial College London | London, W21PG, United Kingdom
Queen Charlotte's and Chelsea Hospital - NICU | London, United Kingdom
St. Mary's Hospital - Winnicott Baby Unit | London, United Kingdom
Location Countries

United Kingdom

Verification Date

April 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Premature babies (<32 weeks)

Description: 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.

Patient Data No
Study Design Info

Observational Model: Ecologic or Community

Time Perspective: Prospective

Source: ClinicalTrials.gov