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| Name | Class |
|---|---|
| The Winnicott Foundation | OTHER |
| National Heart and Lung Institute | OTHER |
| Chelsea and Westminster NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Premature babies born at less than 32 completed weeks gestation
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| Name | Affiliation | Role |
|---|---|---|
| J Simon Kroll, MA BM FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | W21PG | United Kingdom | |||
| Queen Charlotte's and Chelsea Hospital - NICU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32070310 | Derived | 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. | |
| 25344536 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Faecal samples and clinical data were collected from all participants (369 infants) recruited into the study. Samples were only analysed from infants who developed NEC (n=12) and 3 matched controls (n=36). | Posted | Number | Participants | Maximum of 6 months - serial samples collected from each infant (maximum admission duration 6 months), recruitment opened for 24 months. |
|
Recruitment of infants was over a 24 month period during which adverse event data was collected. All infants were followed up until the end of their admission on the neonatal unit, at which point, data collection ceased. All participants recruited were discharged from the neonatal unit two months from the end of the recruitment period. Time frame over which adverse event data were collected: 26 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. No adverse events related to the study occurred. The study was an observational study which only involved the collection of clinical data, faecal samples, urine samples and skin swabs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathleen Sim | Imperial College London | (+44) (0)20 7594 3695 | k.sim@imperial.ac.uk |
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Faecal samples, surplus gut tissue samples (if patient requires bowel resection due to Necrotizing Enterocolitis).
| London |
| United Kingdom |
| St. Mary's Hospital - Winnicott Baby Unit | London | United Kingdom |
| Participants |
|
| Age, Continuous | Median | Full Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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.
|
|
| 30 |
| 369 |
| 0 |
| 369 |
| 0 |
| 369 |
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| D007410 |
| Intestinal Diseases |