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

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.

NCT Number	NCT07163962
Lead Sponsor	Norfolk and Norwich University Hospitals NHS Foundation Trust Collaborators: Quadram Institute Bioscience
Conditions	Vitamin B-12 Deficiency
Enrollment	40 participants
Start Date	2025-09-01
Primary Completion	2026-01-31 (estimated)
Study Completion	2026-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-09