Evaluation of Pain in Preterm Newborn

Study Overview
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Brief Summary
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The purpose of this study is to correlate the composite PIPP-R (Premature Infant Pain Profile-Revised) scale and the parasympathetic nervous system (heart rate variability).

Detailed Description
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The premature newborns hospitalized for several weeks are exposed to a significant number of nursing procedures or painful or stressful medical. Repeated pain in the neonatal period may have negative consequences in the short and / or long term. The diagnosis of pain remains difficult because based on the hetero-assessment involving the use of validated scales. The PIPP-R scale (Premature Infant Pain Profile-Revised) appears to be the most complete and best validated scale as composite (behavior items, vegetative and contextual). However, it is rarely used in routine care in France. Alternatives to clinical scoring the pain level were described, in particular the analysis of the variability of the heart rate [VHR] by HFVI index (High Frequency Variability Index) or skin conductance. The analysis of the spectral components of high frequencies or HFVI would be an indicator of parasympathetic activity. The HFVI was compared to the EDIN scale, purely behavioral level, proposed as chronic pain marker. Skin conductance would be a stress marker reflecting variations of the sympathetic system. These techniques are currently marketed for routine use. However, these methods have been compared and the NIPE (Newborn Infant parasympathetic Evaluation), which assesses the HFVI index, was not compared to a validated scale procedural acute pain (such as PIPP-R). It seems important, before disseminating these methods, explore the consistency of these techniques with each other and validated scales, and their acceptability by nurses.

Official Title
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Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn

Conditions
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Pain, Preterm Newborn

Intervention / Treatment
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* Procedure: Recording of skin conductance and heart rate variability.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborns with gestational age less than 36 weeks Hospitalization in neonatology unit or intensive care unit Signature of major parental consent for participation of their child Exclusion Criteria: Brain injury (intraventricular haemorrhage> Grade 2 or peri- ventricular leukomalacia extended) Administration of anticholinergic or adrenergic antagonist in the previous 48 hours Administration of curares Genetic abnormality or severe malformation

Ages Eligible for Study
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Maximum Age: 2 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preterm newborn<br>Newborns hospitalized in the neonatal or Neonatal Resuscitation unit of Brest University Hospital and born before 36 weeks of gestation who will have recording of skin conductance and heart rate variability. | Procedure: Recording of skin conductance and heart rate variability.<br>* When a procedure of care will be prescribed, installation of the electrodes of measure of the cutaneous conductance on the foot and connection of the NIPE monitor to the cardio-respiratory monitor of the child used in routine. At this stage, beginning of the video recording.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between HFVI index and PIPP-R pain score . | In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation. | 12 months plus the total duration of the patient's hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between skin conductance and pain score PIPP-R. | In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation. | 12 months plus the total duration of the patient's hospitalization | 
| Correlation between skin conductance, HFVI and PIPP-R according to the type of painful procedure: painful or not | This correlation will be measured | 12 months plus the total duration of the patient's hospitalization | 
| Correlation of cutaneous conductance, HFVI and PIPP-R according to the gestational age group type | This correlation will be measured | 12 months plus the total duration of the patient's hospitalization | 
| Correlation of cutaneous conductance, HFVI and PIPP-R according to the sex of the child | This correlation will be measured | 12 months plus the total duration of the patient's hospitalization | 
| Caregiver satisfaction with each technique via the likert scale. | The score will be measured | 12 months plus the total duration of the patient's hospitalization |