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Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance

NCT02764424 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2018-10-25

No results posted yet for this study

Summary

Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator.

Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control.

The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France).

The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.

Conditions

  • Premature Birth
  • Newborn

Interventions

DEVICE

NIPE (MDoloris®)

Each file consists of a simultaneous recording of an electrocardiogram signal according to usual practice (cardiac monitor PHILIPS), coupled with a concomitant registration of NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®). The electrocardiogram signal, respiration rate, oxygen saturation (SpO2) and NIPE are recorded simultaneously on a computer with a capture card. The other indices of Heart Rate Variability will be analyzed offline.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Hugues PATURAL, MD · CHU SAINT-ETIENNE

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2016-11-01
Completion
2016-11-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764424 on ClinicalTrials.gov