Neonatal, Pain Measurement, Reanimation
Conditions
Keywords
NIPE, Newborn Infant Parasympathetic Evaluation, Pain measurement, Neonatal care
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.
Interventions
DEVICEPain measurement during care procedures in neonatal reanimation
Pain measurement during care procedures in neonatal reanimation
Sponsors
University Hospital, Lille
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 7 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of the NIPE measures between before and during care. | From 10 minutes before the care to 10 minutes after the beginning of the care | Average of NIPE mesures 10 minutes before the begining of the care and 10 minutes after. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period | From 10 minutes after the beginning of the care to 10 minutes after the end of the care | 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. |
| Correlation between the NIPEmin and the PIPP-R behavioural scale for each period | From 10 minutes before the care to 10 minutes after the care | 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. |
| 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 | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORRiadh Boukris, MD
University Hospital, Lille
Outcome results
None listed