Clinical trial NCT02885051: Evaluation of Pain in Preterm Newborn
Official title: Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Preterm Newborn
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 91
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between HFVI index and PIPP-R pain score .
timeFrame: 12 months plus the total duration of the patient's hospitalization
Secondary outcomes:
measure: Correlation between skin conductance and pain score PIPP-R.
timeFrame: 12 months plus the total duration of the patient's hospitalization
measure: Correlation between skin conductance, HFVI and PIPP-R according to the type of painful procedure: painful or not
timeFrame: 12 months plus the total duration of the patient's hospitalization
measure: Correlation of cutaneous conductance, HFVI and PIPP-R according to the gestational age group type
timeFrame: 12 months plus the total duration of the patient's hospitalization
measure: Correlation of cutaneous conductance, HFVI and PIPP-R according to the sex of the child
timeFrame: 12 months plus the total duration of the patient's hospitalization
measure: Caregiver satisfaction with each technique via the likert scale.
timeFrame: 12 months plus the total duration of the patient's hospitalization
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
affiliation: CHRU de Brest
name: Jean-Michel Roue, Professor
role: PRINCIPAL_INVESTIGATOR
References: