Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07163962

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Vitamin B-12 Deficiency Avitaminosis Deficiency Diseases Female Urogenital Diseases and Pregnancy Complications Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Norfolk and Norwich University Hospital NHS Foundation Trust

Norwich, United Kingdom

Location contact

Dr Isabel Iglesias-Platas

CONTACT

[email protected]

Dr isabel Iglesias-Platas

PRINCIPAL_INVESTIGATOR

Julie Dawson

CONTACT

[email protected]

+441603 647882

Professor Paul Clarke

SUB_INVESTIGATOR

About this study

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 deficiency (low vitamin B12, high homocysteine and high MMA) under current nutritional guidelines in preterm (born <37 weeks) babies at the time of discharge in preterm infants under current nutritional guidelines.

The investigators will also study whether the risk of deficiency is different in those on an exclusive breast milk diet or in specific gestational age groups (late -34-36 weeks-, moderate -32-33 weeks-, very -28-32 weeks- and extremely -<28 weeks - preterm infants). Folate status will also be analysed. Exploratory outcomes include correlations between calculated intakes and vitamin levels, blood concentrations of other vitamins and cofactors in the same metabolic pathways, content of B vitamins in preterm maternal milk and performance of potential urinary markers of vitamin B12 deficiency in preterm infants.

The trial will take place in a single tertiary-level Neonatal Intensive Care Unit (NICU) and participant families will be recruited while their infant is an inpatient. The project has received Ethical Approval and Informed Consent for mother and baby/ies will be sought before participation.

This trial focuses on the population of preterm-born (<37 weeks of gestation) infants admitted to the Neonatal Unit.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Primary outcomes

  1. Prevalence of biochemical vitamin B12 deficiency

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

    : Percentage of preterm infants with:

    • plasma cobalamin < 148 pmol/L.
    • MMA concentrations >0.26 µmol/L.
    • cB12 < -0.5.

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

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

    • Prevalence of folate deficiency (folate <10 nmol/L)/ elevated serum folate concentrations (>45.3 nmol/L) in preterm infants pre-discharge.
    • Quantification of UnMetabolized Folic Acid (UMFA) levels pre-discharge in preterm infants who receive any form of extra folic acid supplementation.

Other outcomes

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

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

    Blood concentrations of vitamins B1, B2 and B6 (assessed by plasma levels of thiamine pyrophosphate, flavin adenine dinucleotide and pyridoxal 5'-phosphate, respectively).

  2. Explore levels of B vitamins in human milk of mothers delivering prematurely

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

    Measurement of B1, B2, B6, folate and B12 in milk of mothers delivering prematurely. Correlations between concentration in breast milk and calculated total vitamin intake and infant blood levels will be also explored.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Isabel Iglesias-Platas

CONTACT

[email protected]

01603288234

Professor Martin Warren

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Other

Collaborators

  • Quadram Institute Bioscience

Registry information

Official study title

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

Acronym: B-BABIES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.