Ultrasound Assisted or USG Guided versus Conventional Landmark Based Techniques for Lumbar Puncture Success in Neonates:An Open Labelled Randomized Controlled Trial

Lumbar puncture (LP) is a common medical procedure, but its success can be hampered by anatomical variations and patient factors, leading to multiple attempts, traumatic taps, and increased procedural time. While USG guidance has shown promise in improving LP success rates, a direct comparison of USG assisted and USG guided approaches against the conventional method in a randomized controlled setting, and their impact on outcomes, is still lacking. This RCT will enroll 66 neonates per group, with each group undergoing a distinct lumbar puncture technique as outlined below.

In USG assisted group, the ultrasound of the spine will be used preprocedural to identify the optimal intervertebral space and the skin entry point will be marked with a gentian violet ink. The needle insertion will be performed using the marked point. In USG Guided group, ultrasound will be used in real time during needle insertion to visualize the needle tip and in conventional landmark-based group, Lumbar puncture will be performed solely based on anatomical landmarks.

The primary outcomes will be successful lumbar puncture defined as the retrieval of at least 0.5 ml of cerebrospinal fluid (CSF) on the first attempt. Secondary outcomes will include- overall success, number of attempts, traumatic taps and procedural duration. We anticipate that USG guided, and USG assisted techniques will improve the lumbar puncture success by 15 % and 25 % respectively as compared to conventional landmarks.