Maternal, Milk and Baby Markers of Group B Vitamin Metabolism in (Very) Preterm Infants at the Time of Discharge Home
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Prevalence of biochemical vitamin B12 deficiency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth <37 weeks.
- •Admission to one of the participating units.
- •Full enteral milk feeds established by suck/nasogastric tube
排除标准
- •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).
结局指标
主要结局
Prevalence of biochemical vitamin B12 deficiency
时间窗: 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.
次要结局
- 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)