Trial Outcomes & Findings for Defining the Intestinal Microbiota in Premature Neonates (NCT NCT01102738)
NCT ID: NCT01102738
Last Updated: 2020-05-01
Results Overview
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.
COMPLETED
369 participants
Maximum of 6 months - serial samples collected from each infant (maximum admission duration 6 months), recruitment opened for 24 months.
2020-05-01
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
369
|
|
Overall Study
COMPLETED
|
369
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Defining the Intestinal Microbiota in Premature Neonates
Baseline characteristics by cohort
| Measure |
Premature Babies (<32 Weeks)
n=369 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
369 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
2 days
n=5 Participants
|
|
Sex: Female, Male
Female
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
198 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
339 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
369 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Maximum of 6 months - serial samples collected from each infant (maximum admission duration 6 months), recruitment opened for 24 months.Population: 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).
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.
Outcome measures
| Measure |
Premature Babies (<32 Weeks)
n=48 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.
|
|---|---|
|
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.
Klebsiella OTU associated NEC
|
7 Participants
|
|
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.
Clostridium associated NEC
|
4 Participants
|
|
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.
Non Klebsiella or Clostridium associated NEC
|
1 Participants
|
|
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.
Controls
|
36 Participants
|
Adverse Events
Premature Babies (<32 Weeks)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place