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NCT07163962

THE B-BABIES STUDY: An Observational Study of Group B Vitamins in Preterm Infants

Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust

View on ClinicalTrials.gov

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 highest rate of bodily growth across the lifespan. Folate and vitamin B12 are essential in development, and preterm infants may be particularly susceptible to deficiencies. This is the result of a combination of low stores and high requirements for fast growth and rapid red blood cell production in the context of multifactorial anaemia of prematurity. Micronutrient supply, including vitamin B12 and folate, is delivered through nutritional support, in the shape of parenteral nutrition, fortification of human milk of use of artificial formula. Most of this supplementation will be interrupted by the time the infant is getting ready for discharge home. The investigators previously reported high levels of serum folate in preterm infants at the time of discharge home and in early infancy, but there are no contemporary studies investigating the vitamin B12/folate status in this population. The investigators aim to investigate the prevalence of vitamin B12 deficiency in preterm infants at the time of discharge home.

Official title: Maternal, Milk and Baby Markers of Group B Vitamin Metabolism in (Very) Preterm Infants at the Time of Discharge Home

Key Details

Gender

All

Age Range

Any - 28 Days

Study Type

OBSERVATIONAL

Enrollment

40

Start Date

2025-09-01

Completion Date

2026-09-30

Last Updated

2025-09-09

Healthy Volunteers

No

Locations (1)

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, United Kingdom