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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 28
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gestational age at birth <37 weeks.

Admission to one of the participating units.

Full enteral milk feeds established by suck/nasogastric tube

Disqualifiers

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).

Trial population

Preterm infants (born \<37 weeks of gestation)

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
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

* 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.

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

Other outcomes

1

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

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

Time frame
between 34 and 44 weeks postmenstrual age, at the time of hospital discharge
2

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

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.

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

Sponsors and contacts

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