Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates (NCT04794881) | Clinical Trial Compass
CompletedNot Applicable
Repeat Lumbar Puncture at 24 Versus 48 Hours After Traumatic Lumbar Puncture in Neonates
India42 participantsStarted 2019-03-18
Plain-language summary
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.
Who can participate
Age range
1 Day – 28 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: Immediately after the repeat LP reports are available
Trial details
NCT IDNCT04794881
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh