Lumbar puncture in neonates in sitting position, Intervention to minimize trauma to the newborn.

COMPARISON OF SITTING POSITION VERSUS LATERAL POSITION IN NEONATES UNDERGOING LUMBAR PUNCTURE : A RANDOMIZED CONTROLLED STUDY

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064795

Enrollment

100

Registered

2024-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: G039- Meningitis, unspecified

Interventions

Intervention1: lumbar puncture in neonates in sitting versus lateral position, intervention is change of position to minimize trauma to the neonate: Neonates will be randomized into either sitting gro

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria : 1. Neonates with gestational age between 28weeks to 42weeks + 6days 2. Clinical indication for lumbar puncture 3. Neonates for whom written informed consent from parents or legally acceptable representatives is obtained.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Neonates who have already undergone lumbar puncture. 2. Neonates on invasive or non invasive mechanical ventilation 3. Neonates with intraventricular haemorrhage 4. Contraindications to performing lumbar puncture. 5. Neonates in whom sitting position deemed to be difficult according to treating clinician.

Design outcomes

Primary

Measure	Time frame
To evaluate the proportion of neonates with successful lumbar puncture in sitting position versus lateral position. Successful lumbar puncture or non traumatic lumbar puncture is defined as red blood cells less than 10,000 cells/microlitre in csf sample.Timepoint: baseline. lumbar puncture first time in neonate.	—

Secondary

Measure	Time frame
Proportion of neonates with traumatic lumbar puncture (gross or microtraumatic red blood cells more than 10,000cells per microlitre) Incidence of cardiorespiratory instability in sitting & lateral position method defined as apnea or Heart rate fall more than 20 beats per minutes from baseline or SpO2 more than 10 % from baseline. Total duration taken for the procedure Total number of attempts per infant Clinician comfort in performing lumbar puncture in neonates in both groupsTimepoint: baseline, at first lumbar puncture in neonate.5min within lumbar puncture	—

Measure

Time frame

Proportion of neonates with traumatic lumbar puncture (gross or microtraumatic red blood cells more than 10,000cells per microlitre) Incidence of cardiorespiratory instability in sitting & lateral position method defined as apnea or Heart rate fall more than 20 beats per minutes from baseline or SpO2 more than 10 % from baseline. Total duration taken for the procedure Total number of attempts per infant Clinician comfort in performing lumbar puncture in neonates in both groupsTimepoint: baseline, at first lumbar puncture in neonate.5min within lumbar puncture

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Countries

India

Contacts

Public ContactSnehal Manohar Malakari

Indiragandhi Institute Of Child Health, Bangalore

drniranjan_hs@yahoo.com9448046435

Outcome results

None listed

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