Clinical trial NCT02764424: Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance
Official title: Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance : Interest of the Co-evaluation of NIPE and Hetero-assessment Scale : the NIPE-DOL Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Newborn
Keywords: Newborn
Heart Rate Variability (HRV)
Analgesic Nociception Index (ANI)
Autonomous Nervous System (ANS)
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 29
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates over 26 weeks of Gestational Age and under 3 months hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France) will be eligible. They will have to perform a potentially painful care (for example an administration of substances by intramuscular way) in the usual care context.

Brief 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.

Detailed description: 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. Clinical correlations have been completed for adult patients during or after general anesthesia. 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.

Concurrent analysis of autonomic markers (orthosympathetic and parasympathetic indices from time or frequency domain analysis of heart rate variability) will be correlated with the NIPE index in order to study confounding factors that can induce a sympathetic stress without pain sensation and can thus change the indices of nociception.

This study based on a real-time analysis of the perception of pain for newborns is a step for the validation of this new tool that could facilitate the real-time newborn pain management. Furthermore, it will allow caregivers the opportunity to adjust therapeutics in non-communicative patients.

Eligibility criteria: Inclusion Criteria:

* Neonates over 26 weeks of Gestational Age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France);
* Neonates with a potentially painful move programmed (dextro, administration of substances by intramuscular, arterial/ venipuncture, change nasogastric tube, tracheal aspirates).

Exclusion Criteria:

* Newborns sedated;
* Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.

Primary outcomes:
measure: NIPE index
timeFrame: Day 1
Secondary outcomes:
measure: Orthosympathetic and parasympathetic indices
timeFrame: Day 1
measure: Changes in the NIPE index
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hugues PATURAL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cremillieux C, Makhlouf A, Pichot V, Trombert B, Patural H. Objective assessment of induced acute pain in neonatology with the Newborn Infant Parasympathetic Evaluation index. Eur J Pain. 2018 Jul;22(6):1071-1079. doi: 10.1002/ejp.1191. Epub 2018 Mar 24.