Efficacy of Vitamin K prophyaxis in preterm infants intramuscular versus intravenous route: A Randomized Control Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Protein induced by vitamin K absence-II levels in blood
研究概览
简要总结
In preterm infants, regimens of prophylaxis vary widely in terms of dosage,route .The present study is intended to explore the vitamin k status by comparing efficacy of intravenous and intramuscular route by measuring PIVKA -II levels in preterm infants.
Methodology
Study design – Randomized control trial
Total Sample size with justification – 120
n1 – Vitamin K through IV, n2 – Vitamin K through IM
No. of groups - 2
Inclusion criteria
Preterm infants >= 28 weeks
Preterm infants < 33 weeks + 6 Days
Exclusion criteria
Fetal intracranial Hemorrhage (suspected on 18-30 weeks antenatal ultrasound scan].
H/O Alloimmune Thrombocytopenia
Maternal antiplatelet antibodies
Congenital abnormalities
Bruising at Birth
Subgaleal bleed
Mother on treatment with vitamin k antagonist, Heparin, warfarin
Study setting: Level 3 a NICU of a medical college
Parent of eligible infants will be counselled and informed consent will be obtained from parents. Babies will be randomized based on randomization sequence generated using computer generated random sequence. Allocation concealment will be achieved by using serially numbered opaque sealed envelopes (SNOSE). Vitamin K1 will be administered in NICU by intramuscular or intravenous route in an enclosed patient screen by a nursing staff handling allocation concealment not involved in the study. Babies will be randomized to receive 1 mg (0.5ml) Vitamin K1 by Intravenous or Intramuscular route.
Primary outcome
Protein induced by Vitamin K absence - II will be assessed at Day 5 and 30
Secondary outcome (other complications of preterm babies)
Intraventricular hemorrhage
Necrotizing enterocolitis
Late onset sepsis
Bronchopulmonary dysplasia
ROP requiring Laser
Any bleeding manifestation in first 6 months of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm infants between 28 0/7 weeks to 33 6/7 weeks.
排除标准
- •Fetal intracranial Hemorrhage History of Alloimmune Thrombocytopenia Maternal antiplatelet antibodies Major Congenital abnormalities such as congential diaphragmatic hernia, anorectal malformation, VACTERL association, intestinal atresia Bruised at Birth Large Subgaleal bleed Mother on treatment with vitamin k antagonist, Heparin, warfarin APGAR BELOW 3 at 1 minute of life.
结局指标
主要结局
Protein induced by vitamin K absence-II levels in blood
时间窗: Day 5 and Day 30
次要结局
- Retinopathy of prematurity(till 44 weeks post menstrual age)
- late onset sepsis(till hospital stay)
- Nectrotising enterocolitis(till hospital stay)
- Bronchopulmonary dysplasia(till hospital stay)
- Intraventricular hemorrhage(till 44 weeks post menstrual age)
- Any bleeding manifestations(till 6 months of life)
研究者
Divya A
SRM Medical College Hospital and Research Centre