Comparison of high dose vitamin B12 versus standard dose vitamin B12 supplementation in preterm neonates born at 28 to 33 weeks of gestation- a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in hemoglobin (Hb) levels from baseline to 4 weeks of age.
研究概览
简要总结
Anemia is a common condition in preterm neonates, with prevalence ranging from 6-70% based on gestational age. It can lead to complications such as apnea, bradycardia, tachycardia, tachypnea, lethargy, and inadequate weight gain. Vitamin B12 is crucial for erythropoiesis and neonatal health, but supplementation practices vary, and its role in anemia prevention in preterm neonates remains underexplored. By conducting this study, we aim to fill this gap and provide evidence to guide clinical practices for managing anemia in preterm neonates.
This study aims to evaluate the effect of high dose vitamin B12 supplementation in preterm neonates between 28+0-33+6 weeks’ of gestation admitted in a tertiary care hospital on reducing the incidence and severity of anemia.
A prospective, randomized controlled trial will be conducted at the Department of Neonatology, AIIMS Nagpur, where eligible neonates will be randomized into intervention and control groups using block randomization. Baseline assessment of CBC and Vitamin B12 will be done within 24 hours of birth. The intervention group will receive high-dose vitamin B12, while the control group will receive standard care with iron, folic acid, and vitamin B12. Babies allocated in the intervention group will receive high dose (25 mcg) vitamin B12 supplementation via intramuscular route starting at day 7 of life, and repeated every 7 days until discharge. Babies allocated in the control group will receive standard of care as per protocol- standard dose of vitamin B12, iron and folic acid starting at day 14 of life and everyday thereafter. Serial CBC assessment will be done every 7 days till discharge and serial vitamin B12 assessment will be done once at baseline, then every 14 days till discharge. Maternal serum vitamin B12 will also be assessed at baseline within 24 hours of delivery.
The primary objective is to evaluate the impact of high-dose vitamin B12 on hemoglobin levels from baseline to 4 weeks of age. Secondary objectives include assessing the reduction in anemia incidence, changes in RBC indices, serum vitamin B12 levels, anemia requiring transfusion, maternal and neonatal vitamin B12 correlation, and changes in growth parameters.
Babies will be monitored during NICU stay until discharge and followed up till 4 months of chronological age on OPD basis once monthly after discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm neonates between 28+0-33+6 weeks’ of gestation admitted to the NICU at AIIMS Nagpur.
排除标准
- •Out-born preterm neonates between 28+0-33+6 weeks’ of gestation admitted after 24 hours of birth to the NICU at AIIMS Nagpur.
- •Parents and guardians unwilling to provide consent for the study.
- •Major congenital malformation.
- •Hemolytic disease.
- •Twin to twin transfusion syndrome.
- •Major hemorrhage (including IVH grade III/IV, major GI bleed, UVC bleed, history of peripartum hemorrhage).
结局指标
主要结局
Change in hemoglobin (Hb) levels from baseline to 4 weeks of age.
时间窗: Baseline Hb will be evaluated with CBC within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Change in Hb levels will be assessed.
次要结局
- Reduction in the incidence of anemia.(Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Anemia will be diagnosed based on available reference charts.)
- Change in RBC indices (MCV, RBC count, reticulocyte count).(Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge.)
- Change in serum vitamin B12 levels.(Baseline value of serum Vitamin B12 will be taken within 24 hours of life and then repeated every 14 days, before administration of dose of intramuscular injection of vitamin B12 till discharge.)
- Incidence of anemia requiring blood transfusion.(Baseline Complete blood count will be taken within 24 hours of birth and repeated every 7 days before administration of next dose of intramuscular injection of vitamin B12 till discharge. Blood transfusion cut- off will be decided as per unit protocol as mentioned in annexure.)
- Association between maternal serum B12 and neonatal serum B12 levels.(Maternal serum Vitamin B12 levels will be assessed once at baseline, i.e. within 24 hours of delivery.)
- Change in growth parameters on receiving vitamin B12 therapy(Anthropometry recordings of length, weight and head circumference will be done at admission then once every week till discharge.)
研究者
Dr Nishant Banait
All India Institute of Medical Sciences, Nagpur