CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 420 enrolled
Drug / intervention
Application of a validated Clinical Decision Rule (CDR) as an AHT screening toolother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03162354
NCT03162354N/ACompleted

Implementation Trial of a Validated Clinical Decision Rule for Pediatric Abusive Head Trauma (NIH Grant Number P50HD089922)

Milton S. Hershey Medical Center·interventional·Posted May 22, 2017·Updated Dec 16, 2020

In Brief

A clinical study evaluating Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool for Pediatric Abusive Head Trauma. Completed, enrolled 420 participants across 8 sites.

Detailed Summary

To increase the accuracy of doctors' decisions to launch or forgo child abuse evaluations in their young, acutely head-injured patients, investigators have derived and validated a clinical decision rule (CDR) that detects abusive head trauma (AHT) with 96% sensitivity in pediatric intensive care unit (PICU) settings. This "CDR Implementation Trial" across eight PICU sites will assess the CDR's actual impact on AHT screening accuracy, identify factors associated with maximal physician acceptance and application of this novel AHT screening tool, and assess the sustainability of active CDR implementation strategies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 22, 2017
Enrollment StartAug 1, 2017
Primary CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago

Interventions

Application of a validated Clinical Decision Rule (CDR) as an AHT screening toolother

The Clinical Decision Rule (CDR) for AHT reads as follows: Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered "high risk" and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture.