Evaluation of Pain in Preterm Newborn (TRIPAIN)
Primary Purpose
Pain, Preterm Newborn
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Recording of skin conductance and heart rate variability.
Sponsored by

About this trial
This is an interventional other trial for Pain
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
Sites / Locations
- CHRU Brest
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
preterm newborn
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Correlation between skin conductance, HFVI and PIPP-R according to the type of painful procedure: painful or not
This correlation will be measured
Correlation of cutaneous conductance, HFVI and PIPP-R according to the gestational age group type
This correlation will be measured
Correlation of cutaneous conductance, HFVI and PIPP-R according to the sex of the child
This correlation will be measured
Caregiver satisfaction with each technique via the likert scale.
The score will be measured
Full Information
NCT ID
NCT02885051
First Posted
August 26, 2016
Last Updated
October 26, 2020
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02885051
Brief Title
Evaluation of Pain in Preterm Newborn
Acronym
TRIPAIN
Official Title
Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
At the end of the inclusion period, the observed correlations were much lower than expected. Thus, it did not seem relevant to prolong the inclusions.
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
January 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Preterm Newborn
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
preterm newborn
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Recording of skin conductance and heart rate variability.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between HFVI index and PIPP-R pain score .
Description
In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation.
Time Frame
12 months plus the total duration of the patient's hospitalization
Secondary Outcome Measure Information:
Title
Correlation between skin conductance and pain score PIPP-R.
Description
In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation.
Time Frame
12 months plus the total duration of the patient's hospitalization
Title
Correlation between skin conductance, HFVI and PIPP-R according to the type of painful procedure: painful or not
Description
This correlation will be measured
Time Frame
12 months plus the total duration of the patient's hospitalization
Title
Correlation of cutaneous conductance, HFVI and PIPP-R according to the gestational age group type
Description
This correlation will be measured
Time Frame
12 months plus the total duration of the patient's hospitalization
Title
Correlation of cutaneous conductance, HFVI and PIPP-R according to the sex of the child
Description
This correlation will be measured
Time Frame
12 months plus the total duration of the patient's hospitalization
Title
Caregiver satisfaction with each technique via the likert scale.
Description
The score will be measured
Time Frame
12 months plus the total duration of the patient's hospitalization
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Roue, Professor
Organizational Affiliation
CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29609
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Learn more about this trial
Evaluation of Pain in Preterm Newborn
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