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| Name | Class |
|---|---|
| Quadram Institute Bioscience | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of biochemical vitamin B12 deficiency | : Percentage of preterm infants with:
| between 34 and 44 weeks postmenstrual age, at the time of hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | between 34 and 44 weeks postmenstrual age, at the time of hospital discharge |
Inclusion Criteria:
Exclusion Criteria:
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Preterm infants (born <37 weeks of gestation)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Isabel Iglesias-Platas | Contact | 01603288234 | isabel.iglesias-platas@nnuh.nhs.uk | |
| Professor Martin Warren | Contact | Martin.Warren@quadram.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Dr Isabel Iglesias-Platas | Norfolk and Norwich University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norfolk and Norwich University Hospital NHS Foundation Trust | Norwich | United Kingdom |
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| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| D047928 | Premature Birth |
| D001361 | Avitaminosis |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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Blood, stool, urine, milk
| 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 | 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. | between 34 and 44 weeks postmenstrual age, at the time of hospital discharge |
| D009750 |
| Nutritional and Metabolic Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |