| CTRI Number |
CTRI/2025/10/095988 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
ultrasound versus standard lumbar puncture (spinal tap) methods for first attempt success in neonates . |
|
Scientific Title of Study
|
Ultrasound Assisted or USG Guided versus Conventional Landmark Based Techniques for Lumbar Puncture Success in Neonates:An Open Labelled Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satish Saluja |
| Designation |
Chairperson |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Neonatology ,Institute of Child Health ,Sir Ganga Ram Hospital ,Sir Ganga Ram Hospital Marg,Old Rajendra Nagar,New Delhi
Central
DELHI
110060
India |
| Phone |
9811047389 |
| Fax |
|
| Email |
satishsaluja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Saluja |
| Designation |
Chairperson |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Neonatology ,Institute of Child Health ,Sir Ganga Ram Hospital ,Sir Ganga Ram Hospital Marg,Old Rajendra Nagar,New Delhi
DELHI
110060
India |
| Phone |
9811047389 |
| Fax |
|
| Email |
satishsaluja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prithiviraj |
| Designation |
DrNB Trainee |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Department of Neonatology ,Institute of Child Health ,Sir Ganga Ram Hospital ,Sir Ganga Ram Hospital Marg,Old Rajendra Nagar,New Delhi
Central
DELHI
110060
India |
| Phone |
09787166979 |
| Fax |
|
| Email |
tvmprithiviraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Satish Saluja |
| Address |
Department of Neonatology, Institute of Child Health, Sir Ganga Ram Hospital,Sir Ganga Ram Hospital Marg, old Rajendira Nagar, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Prithiviraj P |
Department of Neonatology, Institute of Child Health, Sir Ganga Ram Hospital,Sir Ganga Ram Hospital Marg, old Rajendira Nagar, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Satish Saluja |
Sir Ganga Ram Hospital |
Department of Neonatology,Institute of Child Health,Sir Ganga Ram Hospital,Sir Ganga Ram Hospital Marg,Old rajendra nagar,New Delhi
Central
DELHI |
9811047389
satishsaluja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee ,Sir Ganga Ram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00||Bacterial meningitis, not elsewhere classified, (2) ICD-10 Condition: G03||Meningitis due to other and unspecified causes, (3) ICD-10 Condition: G01||Meningitis in bacterial diseases classified elsewhere, (4) ICD-10 Condition: G02||Meningitis in other infectious andparasitic diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional landmark based Lumbar puncture |
Lumbar puncture will be performed solely based on anatomical landmarks. |
| Intervention |
Ultrasound assisted lumbar puncture |
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. |
| Intervention |
USG Guided Lumbar Puncture |
Ultrasound will be used in real time during needle insertion to visualize the needle tip and puncture the spinal duramater for Cerebrospinal fluid collection. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates admitted to NICU who need lumbar puncture.
Neonates up to 44-week Post menstrual age. |
|
| ExclusionCriteria |
| Details |
Known spinal cord abnormality (e.g., tethered cord, spina bifida, or other developmental defects of the spine and spinal cord).
Presence of skin and soft tissue infection at the planned lumbar puncture insertion site.
Recent failed LP or traumatic LP attempts within the preceding 48 hours.
Recent diagnosis of intraventricular hemorrhage within the preceding 7 days.
Neonates with coagulopathy or thrombocytopenia. (less than 50000/microliter)
Neonates with cardiorespiratory instability whose condition may be exacerbated by the procedure.
Neonates with uncontrolled seizures.
Any other contraindications to lumbar puncture as determined by the clinical team. Failure to obtain consent
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful first attempt lumbar puncture. |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall success rate |
nil |
| Number of attempts |
nil |
| Traumatic tap |
nil |
| Duration of procedure |
nil |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |