CTRI/2020/01/022964已完成3 期
Effect of limiting blood sampling losses in early postnatal period in extremely premature neonates- A Randomized controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Need for Packed RBC transfusions
研究概览
简要总结
Primary purpose of the study is to (a) assess the feasibility of limited blood sampling approach,(b) determine the effect of limiting phlebotomies on transfusion requirements in extremely premature neonates.Our hypothesis is that a limited blood sampling approach would result in a significant reduction in the proportion of neonates requiring packed RBC transfusions in the first 6 weeks of postnatal age . Eligible neonates will be stratified for gestational age and the primary outcome estimates would be adjusted for gestational age and haemoglobin at admission. Interim analysis for safety would be performed after 50% enrolment in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 30.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm infants ≤ 28 weeks of gestation and ≤ 1 kg birth weight,enrolled at 12-24 hours of postnatal age.
排除标准
- •1.Placenta previa, Abruptio placentae, Retroplacental hemorrhage (Concealed hemorrhage) 2.Monochorionic twins/triplets/Quadruplets 3.Rh isoimmunisation 4.Hydrops fetalis
- •Major congenital anomalies in the infant like Gastroschisis, Exomphalos.
- •Extremely sick neonates who are deemed unlikely to survive beyond first 72 hours of life.
结局指标
主要结局
Need for Packed RBC transfusions
时间窗: At 6 weeks of postnatal age
次要结局
- Need for packed RBC transfusion
- Time to first packed RBC transfusion(At the time of discharge)
- Phlebotomy loss volume
- Weekly hemoglobin level
- severe Intraventricular haemorrhage(Grade 3 or 4)(At the time of discharge)
- Number of transfusions
- All cause mortality
- Patent ductus arteriosus requiring treatment
- Necrotising enterocolitis (stage 2 or more)
- Bronchopulmonary Dysplasia(Oxygen requirement at 36 weeks)
- Periventricular Leukomalacia(At the time of discharge)
- Time to reach full feeds
- Duration of respiratory support (days)
- Duration of hospital stay (days)
- Late onset sepsis ( culture positive)
- Retinopathy of prematurity requiring intervention.
- Neurodevelopmental outcomes
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A clinical trial on the effect of reducing blood sampling in extremely preterm neonatesCTRI/2020/01/022964Surya Hospital102
Unknown
不适用
The Influence of Blood Sampling Technique on the Total Amount of Blood Collected for Laboratory Testing Critically Ill Pediatric PatientsIatrogenic AnaemiaNCT06376747Brno University Hospital100
已完成
不适用
Characterization of Fecal Microbiota in a Population Aged 50 to 75 Years Targeted by Seasonal VaccinationElderly VolunteersNCT05972590Bioaster60
已完成
不适用
Research on the Application of Blood Collection Through Midline Catheters of Different LengthsCatheter ComplicationsNCT06014099Sir Run Run Shaw Hospital162
已完成
1 期
Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) StudyRheumatoid ArthritisNCT02528786Takeda8