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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02695784
Other study ID # 7840
Secondary ID
Status Recruiting
Phase Phase 4
First received February 25, 2016
Last updated December 22, 2017
Start date September 1, 2017
Est. completion date September 1, 2019

Study information

Verified date December 2017
Source Newcastle-upon-Tyne Hospitals NHS Trust
Contact Janet Berrington, MBBS MD
Phone 01912825197
Email janet.Berrington@nuth.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The influence of the preterm gut microbiota in health and disease has been well established. However, relatively little is known about how the microbiome changes after discharge and its relationship with growth, health and disease outcomes in the preterm population. This study aims to follow a cohort of preterm infants and explore the relationship of the later microbiome ('after discharge') with later growth and health outcomes in infancy. The study will also explore the effect of timing of stopping routinely administered probiotics on the post-discharge microbiome, infant feeding and outcomes such as colic.

The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who have also taken part in the investigators microbiome study during their NICU stay (SERVIS REC No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The investigators will collect stool at and beyond the time of anticipated discharge (beyond 34 weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge timing of these infants varies, and is usually latest in the most immature infants, allowing an assessment of the influence of physical location (NICU vs home) as well as increasing age. Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial colonisation of the gut and measure infant weight, length and head circumference at each time point. The investigators will use a parent questionnaire to assess daily crying time, parents' perceptions of colic severity using a visual analogue scale as well as vomiting and constipation for the two weeks before sampling.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 32 Weeks
Eligibility Inclusion Criteria:

- <32 weeks Corrected Gestation

- Followed up in Newcastle Region

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic Continuation
This arm will continue to receive probiotics beyond 34 weeks corrected gestation until two months after discharge

Locations

Country Name City State
United Kingdom Newcastle Neonatal Service Newcastle Upon Tyne Tyne And Wear

Sponsors (2)

Lead Sponsor Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microbiome 16S RNA assessed using illumina sequencer one year
Secondary Growth Velocity Weight Increase in g/kg/day 1 year
Secondary Head Growth cm/kg/day 1 year
Secondary Growth: Length Length: cm/kg/day 1 year
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