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A study to incorporate ultrasound to an existing CT head clinical decision tool in children less than 2 years to see if this combination is more accurate than the original CT head decision tool, thereby aiming to reduce unnecessary CT radiation to paediatric population

SONO-PECARN versus PECARN rule To study the role of point of care ultrasound guided skull bone fracture detection in decision making in the intermediate risk group of PECARN head CT rule in children less than 2 years A randomised control study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081244
Enrollment
848
Registered
2025-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: S029- Fracture of unspecified skull andfacial bones

Interventions

Intervention1: CT done based on SONO-PECARN rule: CT done after performing ultrasound to detect skull fracture DURATION: 2.5 YEARS Control Intervention1: CT done based on only PECARN rule: CT head do

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of suspected clinically significant traumatic brain injury paediatric patients less than two years of age will be enrolled

Exclusion criteria

Exclusion criteria: Patients with injuries of more than 72 hours old, previous fractures at the affected site, evidence of obvious deformities, complex injuries, open fractures, unconscious or unstable patients, and patients with age more than 2 years will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure will be the sensitivity and specificity of point of care ultrasound and PECARN rule in comparison to the final diagnosis of clinically significant traumatic brain injury on CTTimepoint: AT BASELINE—

Secondary

MeasureTime frame
TRAUMATIC BRAIN INJURY DETECTED AFTER CTTimepoint: AT BASELINE;NEUROLOGIVAL STATUS OF THE PATIENTTimepoint: AT DISCHARGE—

Countries

India

Contacts

Public ContactDr SANJEEV BHOI

AIIMS NEW DELHI

sanjeevbhoi@gmail.com8527050391

Outcome results

None listed

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