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To compare Lumbar Puncture(A procedure by which cerebrospinal fluid is obtained from back by inserting needle)done conventionally with the Lumbar puncture done with assistance of ultrasonography

Comparison of Ultrasound Assisted Vs Palpation Method for Diagnostic Lumbar Puncture in Neonates:A Randomized Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025679
Enrollment
228
Registered
2020-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ultrasound assisted Lumbar Puncture: Neonates randomized to the intervention group after ruling out the exclusion criteria ( review of Haematology and Cranial Ultrasound) will be subje

Sponsors

Ch Pradeep Chandu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Neonates >=28 Weeks in whom the treating team decides a CSF analysis is required for diagnosis will be included in the study

Exclusion criteria

Exclusion criteria: 1.Thrombocytopenia 2.Diagnosed Coagulopathies including deranged INR with or without bleeding 3.Cardio respiratory compromise evidenced by need of more than one inotrope or single inotrope with dose more than 15 microgram/kg/min infusion. 4.Congenital lumbosacral Malformations such as Neural tube defects 5.Infection or Exfoliation at the spinal area of performing LP 6.Diagnosed dysgenic brain on bedside Ultrasonography 7.Grade II IVH or more 8.Neonate on Invasive ventilator support. 9.Babies requiring LP for more than once 10.Any other factor that is contraindication to the procedure for LP

Design outcomes

Primary

MeasureTime frame
Successful Lumbar puncture (defined as no dry tap and CSF RBC less than 1000 per mm3)Timepoint: Baseline(Csf collected will be sent for cell count and report will be collected within few hours)

Secondary

MeasureTime frame
1.Time taken for the procedure(from the point of contact of USG probe with skin till obtainment of CSF in intervention method and point of contact of hand with skin after sterilisation till obtainment of CSF in Control method) 2. Pain assessment using Neonatal Infant Pain Score (NIPS). 3.USG estimation of the point of formation of Conus for different gestation. 4.USG estimation of the Depth of insertion in different gestation. Timepoint: Baseline(All secondary outcomes will be recorded during time of procedure)

Countries

India

Contacts

Public ContactCh Pradeep Chandu

Maulana Azad Medical College

neoashish2008@gmail.com9810694789

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026