Status:
NOT_YET_RECRUITING
THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants
Lead Sponsor:
Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborating Sponsors:
Quadram Institute Bioscience
Conditions:
Vitamin B-12 Deficiency
Eligibility:
All Genders
Up to 28 years
Brief Summary
Infancy may be associated with a risk of micronutrient depletion due to the high demands of rapid growth. This is particularly true when preterm birth occurs, as the period before term exhibits the hi...
Detailed Description
This is an observational, cross-sectional study of infants born preterm (gestational age at birth \<37 weeks) and their mothers. The investigators aim to estimate the prevalence of vitamin B12 deficie...
Eligibility Criteria
Inclusion
- Gestational age at birth \<37 weeks.
- Admission to one of the participating units.
- Full enteral milk feeds established by suck/nasogastric tube
Exclusion
- Known or suspected chromosomal, genetic or metabolic abnormalities.
- Major congenital malformations
- Any intercurrent condition that precludes implementation of standard feeding protocols and requires specialized formulas or changes in standard vitamin supplementation.
- Any intercurrent condition that will interfere with the interpretation of results (renal impairment and hypothyroidism can lead to elevated tHcy and MMA, for example).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07163962
Start Date
September 1 2025
End Date
September 30 2026
Last Update
September 9 2025
Active Locations (1)
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1
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom