Repeating a Lumbar Puncture at 24 Hours Versus 48 Hours After a Macro-traumatic Lumbar Puncture in Newborn Infants: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Area under the the receiver operating characteristic (ROC) curve of uncorrected CSF WBC count in the repeat LP, with "definite or probable meningitis" taken as the reference standard.
研究概览
简要总结
Visibly traumatic as well as microtraumatic lumbar punctures (LP) are very common in the neonatal period. The presence of blood makes it difficult to interpret cerebro-spinal fluid (CSF) findings. Clinicians often perform a repeat LP in the hope that some of the red blood cells would have cleared by then, allowing a better interpretation of the CSF findings. There is no published information whether a repeat LP provides any added information to the original traumatic LP, and if so what is the best time to repeat an LP after a traumatic LP. In this randomised controlled trial (RCT), we plan to randomly allocate neonates following a visibly traumatic LP to either undergo a repeat LP at 24 hours or 48 hours later to determine which LP gives more accurate results.
详细描述
STUDY DESIGN An open-label Randomised Control Trial, with stratification and blocking. STUDY SETTING The Newborn unit and Neonatal Unit of Pediatric Emergency of Post graduate Institute of medical education and research (PGIMER).
The former is a level 3 Neonatal Intensive Care Unit (NICU). STUDY PERIOD Mentioned elsewhere ELIGIBILITY CRITERIA Mentioned elsewhere CONSENT A parent information sheet was provided. Informed written consent was obtained from the parents of the patient following which subjects were included in the study. The consent included information about the procedure and study related to it. It also included the risk factors associated with and after the procedure. All subjects were included after obtaining wilful consent from respective parents.
PROCEDURE Post enrolment uncorrected White blood cell (WBC), corrected WBC count, red blood cell (RBC) count, Glucose concentration, Protein concentration, CSF Procalcitonin concentration, Gram stain and culture and sensitivity of microorganism was performed.
Post-LP the subject was randomized and repeat LP was performed either after 24 hours or 48 hours, and uncorrected WBC, corrected WBC count, RBC count, Glucose concentration, Protein concentration, Gram stain, and Culture and sensitivity of microorganism was studied.
BASELINE PARAMETERS Gestation, Birth weight, Sex, Postnatal age, Current weight, Indication for initial lumbar puncture in the neonate, Seniority level of the person doing the initial lumbar puncture, Platelet count when available before initial lumbar puncture, The coagulation study report, if available, before initial lumbar puncture and repeat lumbar puncture, Whole blood glucose measured by glucometer before the initial LP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn infants admitted anywhere in the Neonate unit or Neonatal Unit of Paediatric Emergency
- •Underwent lumbar puncture as part of the workup for sepsis
- •Cerebrospinal fluid visibly tinged with blood (macro traumatic). To ensure objectivity, two Pediatricians must have a consensus that the CSF sample is visibly blood-tinged when viewed in bright ambient light.
排除标准
- •Clinically too unstable to undergo 2 lumbar punctures within the span of 48 hours
- •Lumbar puncture performed after more than 3 doses of antibiotics administered
- •CSF sample of traumatic lumbar puncture not sent for analysis of WBC, RBC counts, glucose, protein, Gram stain, and culture
- •Sample appears to be pure blood from the initial needle prick.
- •Post-randomization exclusion
- •Clinically too unstable to undergo the 2nd LP
- •Development of fresh contraindications for performing the 2nd LP
研究组 & 干预措施
24 hours
Newborn infants in this group will undergo repeat lumbar puncture at 24 hours after a traumatic lumbar puncture
干预措施: 24 hours (Other)
48 hours
Newborn infants in this group will undergo repeat lumbar puncture at 48 hours after a traumatic lumbar puncture
干预措施: 48 hours (Other)
结局指标
主要结局
Area under the the receiver operating characteristic (ROC) curve of uncorrected CSF WBC count in the repeat LP, with "definite or probable meningitis" taken as the reference standard.
时间窗: Immediately after the repeat LP reports are available
Primary outcome- area under the ROC curve of uncorrected CSF WBC count in the repeat LP- will be compared between the 24 hour LP and the 48 hour LP groups. The reference standard will be "definite or probable meningitis" defined as "CSF culture and/or CSF Gram stain and/or CSF Procalcitonin positive" in the baseline traumatic LP.
次要结局
- Area under the ROC curve of corrected CSF WBC count (using 500:1 formula) in the repeat LP, with only "definite meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of CSF glucose in the repeat LP, with only "probable meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of corrected CSF WBC count (using 500:1 formula) in the repeat LP, with "definite or probable meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of CSF protein in the repeat LP, with only "definite meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of CSF glucose in the repeat LP, with only "definite meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of corrected CSF WBC count (using 500:1 formula) in the repeat LP, with only "probable meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of CSF glucose in the repeat LP, with "definite or probable meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of CSF protein in the repeat LP, with only "probable meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Area under the ROC curve of CSF protein in the repeat LP, with "definite or probable meningitis" taken as a reference standard(Immediately after the repeat LP reports are available)
- Percentage change in RBC count from baseline traumatic LP to the repeat LP(Immediately after the repeat LP reports are available)
- Percentage change in uncorrected CSF WBC count from baseline traumatic LP to the repeat LP(Immediately after the repeat LP are available)
研究者
Sourabh Dutta
Professor of Pediatrics
Post Graduate Institute of Medical Education and Research, Chandigarh