Clinical Trials Logo

Clinical Trial Summary

The main objective is to assess correlation between Newborn Infant Parasympathetic Index values and external evaluation by Comfort Behaviour Scale during painful medical cares in sedated intubated children admitted in pediatric intensive care unit.


Clinical Trial Description

The assessment of pain in patient hospitalized in intensive care remains a challenge, especially for patients which are unable to communicate their pain intensity. Self-reported scales are widely used for children's pain assessment but cannot be used in sedated or non-communicable patients. The gold standard for pain evaluation in sedated-ventilated patient in pediatric intensive care unit is the Comfort Behaviour Scale (CBS). However, this method remains subjective, depending on training and ability to use this clinical tool by the examiner. The Newborn Infant Parasympathetic Evaluation (NIPE) is a non-invasive system based on the analysis variability in high frequency (> 0.15 Hz) which reflects the parasympathetic activity related to respiratory fluctuations of heart rate. With a numerical index ranging from 0 to 100, NIPE values, measured continuously, has been developed to evaluate the degree of pain intensity. In this study, the hypothese is the NIPE could be used as an indicator of pain in sedated/intubated children under 3 years-old hospitalized in Pediatric intensive care unit.

This study did not change the procedure of care before or after and had no impact on care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04195672
Study type Observational
Source University Hospital, Lille
Contact
Status Completed
Phase
Start date November 1, 2017
Completion date April 30, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05609773 - Comparing Intubation Rates in the Delivery Room by Interface
Recruiting NCT05968586 - Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants N/A
Not yet recruiting NCT06026163 - Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress Phase 2/Phase 3
Recruiting NCT04865302 - Cerebral Oxygenation in Preterm Neonates With Respiratory Support During Skin-to-skin Care on the First Day After Birth
Completed NCT03388437 - Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation N/A
Completed NCT03163108 - Closed-loop Automatic Oxygen Control (CLAC-4) in Preterm Infants N/A
Completed NCT04659083 - How NAVA Works in Preterm Infants With Irregular Respiratory Efforts
Completed NCT03895242 - Prone and Supine Positions in Preterm Infants Receiving Mechanical Ventilation N/A
Recruiting NCT05824377 - To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation. N/A
Recruiting NCT05987800 - Non-invasive Ventilation in Preterm Infants N/A
Completed NCT05706428 - Cardiorespiratory Effects of Nasal High Frequency Ventilation in Neonates N/A
Completed NCT04068558 - sNIPPV Versus NIV-NAVA in Extremely Premature Infants N/A
Recruiting NCT03785899 - Automatic Oxygen Control (SPOC) in Preterm Infants N/A
Recruiting NCT05454332 - The Caffeine Therapy in the Fetal to Neonatal Transition Phase 4
Completed NCT04836689 - Influence of Respiratory Rate Settings on CO2 Levels During Nasal Intermittent Positive Pressure Ventilation (NIPPV). N/A