Defining the Intestinal Microbiota in Premature Neonates

NCT01102738 | Completed Results DMC

• 1 other identifier: CR01542
• Study Type: observational
• Target: 369
• Locations: 1 country
• Sites: 3

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.

Conditions

Premature Intestinal Microbiota; Necrotizing Enterocolitis; Late Onset Bloodstream Infection

Keywords

Premature intestinal microbiota; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Faecal samples were analysed using 16S rRNA gene sequencing to determine the bacterial content present in faecal samples collected from pre term infants prior to the onset of necrotising enterocolitis. Bacteria were identified and relative proportions reported for each faecal sample analysed.

  Maximum of 6 months - serial samples collected from each infant (maximum admission duration 6 months), recruitment opened for 24 months.

Study Arms (1)

Premature babies (<32 weeks)

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.

Eligibility Criteria

• Age: Up to 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature babies born at less than 32 completed weeks gestation

You may qualify if:

• 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.

You may not qualify if:

• All babies born at more than 32 completed weeks gestation will be excluded from the study.

Sponsors & Collaborators

• Imperial College London: lead
• The Winnicott Foundation: collaborator
• National Heart and Lung Institute: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator

Study Sites (3)

Imperial College London

London, W21PG, United Kingdom

Location

Queen Charlotte's and Chelsea Hospital - NICU

London, United Kingdom

Location

St. Mary's Hospital - Winnicott Baby Unit

London, United Kingdom

Location

Related Publications (2)

• Shaw AG, Cornwell E, Sim K, Thrower H, Scott H, Brown JCS, Dixon RA, Kroll JS. Dynamics of toxigenic Clostridium perfringens colonisation in a cohort of prematurely born neonatal infants. BMC Pediatr. 2020 Feb 18;20(1):75. doi: 10.1186/s12887-020-1976-7.

  PMID: 32070310 DERIVED

• Sim K, Shaw AG, Randell P, Cox MJ, McClure ZE, Li MS, Haddad M, Langford PR, Cookson WO, Moffatt MF, Kroll JS. Dysbiosis anticipating necrotizing enterocolitis in very premature infants. Clin Infect Dis. 2015 Feb 1;60(3):389-97. doi: 10.1093/cid/ciu822. Epub 2014 Oct 23.

  PMID: 25344536 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal samples, surplus gut tissue samples (if patient requires bowel resection due to Necrotizing Enterocolitis).

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr. Kathleen Sim
• Organization: Imperial College London

k.sim@imperial.ac.uk

(+44) (0)20 7594 3695

Study Officials

• J Simon Kroll, MA BM FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 13, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2014
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)