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

NCT07163962 | Not Yet Recruiting

• 1 other identifier: 2024GRANT058
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vitamin B-12 Deficiency

Keywords

Preterm infant; vitamin B12; Folate; Folic acid; Vitamin deficiency; Micronutrition

Outcome Measures

Primary Outcomes (1)

• Prevalence of biochemical vitamin B12 deficiency

  : Percentage of preterm infants with: * plasma cobalamin \< 148 pmol/L. * MMA concentrations \>0.26 µmol/L. * cB12 \< -0.5.

  between 34 and 44 weeks postmenstrual age, at the time of hospital discharge

Secondary Outcomes (1)

• Prevalence of biochemical vitamin B12 deficiency in each gestational age group: late (34-36 weeks at birth), moderate (32-33 weeks at birth), very (28-32 weeks at birth) and extremely (<28 weeks at birth) preterm infants at the time of hospital discharge

  between 34 and 44 weeks postmenstrual age, at the time of hospital discharge

Other Outcomes (2)

• To explore levels of other metabolites related to B12/folate pathways in preterm infants (including vitamin B6 and copper/zinc).

  between 34 and 44 weeks postmenstrual age, at the time of hospital discharge

• Explore levels of B vitamins in human milk of mothers delivering prematurely

  between 34 and 44 weeks postmenstrual age, at the time of hospital discharge

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants (born \<37 weeks of gestation)

You may qualify if:

• Gestational age at birth \<37 weeks.
• Admission to one of the participating units.
• Full enteral milk feeds established by suck/nasogastric tube

You may not qualify if:

• 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).

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• Quadram Institute Bioscience: collaborator

Study Sites (1)

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, urine, milk

MeSH Terms

Conditions

Vitamin B 12 Deficiency; Premature Birth; Avitaminosis

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dr Isabel Iglesias-Platas

  Norfolk and Norwich University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Isabel Iglesias-Platas

CONTACT

01603288234; isabel.iglesias-platas@nnuh.nhs.uk

Professor Martin Warren

CONTACT

Martin.Warren@quadram.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion: January 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-08

Locations

GB (1)