Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.

Study Overview
=================
Brief Summary
-----------------
The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component). So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.

Official Title
-----------------
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.

Conditions
-----------------
Neonatal, Pain Measurement, Reanimation

Intervention / Treatment
-----------------
* Device: Pain measurement during care procedures in neonatal reanimation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant born very premature before 34 weeks of amenorrhoea + 0 day Age ≤ 7 days Admitted in neonatal reanimation Sedated, intubated, ventilated Exclusion Criteria: High frequency oscillation ventilation Heart rate non sinusal Inotropes and atropine Opposition from the guardian of parental authority Difficulty of comprehension or communication making the parental information impossible

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 7 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pain measurement during care procedures in neonatal reanimation|Pain measurement during care procedures in neonatal reanimation|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the NIPE measures between before and during care. | Average of NIPE mesures 10 minutes before the begining of the care and 10 minutes after. | From 10 minutes before the care to 10 minutes after the beginning of the care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period | The average of NIPE mesures 10 minutes before care, 10 minutes after the begining and 10 minutes after the end of the care were collected. And the same for the PIPP-R behavioral scale mesures. | From 10 minutes after the beginning of the care to 10 minutes after the end of the care | 
| Correlation between the NIPEmin and the PIPP-R behavioural scale for each period | The lowest NIPE mesures during the 10 minutes before care, 10 minutes after the begining and 10 minutes after the end of the care were collected. And the same for the PIPP-R behavioral scale mesures. | From 10 minutes before the care to 10 minutes after the care | 
| The discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale | Study the discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale | From 10 minutes before the care to 10 minutes after the care | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NIPE, Newborn Infant Parasympathetic Evaluation, Pain measurement, Neonatal care