PainTRIPAINNCT02885051
Evaluation of Pain in Preterm Newborn
A study testing Recording of skin conductance and heart rate variability. in people with Pain and Preterm Newborn, run by University Hospital, Brest at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Pain, Preterm Newborn
- What is being tested?
- Recording of skin conductance and heart rate variability.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2017to 24 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn
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).
Read the 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.
- Conditions
- Pain, Preterm Newborn
- Being tested
- Recording of skin conductance and heart rate variability.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of skin conductance and heart rate variability.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| preterm newborn | Experimental | 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. Receives: Procedure: Recording of skin conductance and heart rate variability. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months plus the total duration of the patient's hospitalization
Secondary outcomes (5)
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.
Measured: 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
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
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
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
Measured: 12 months plus the total duration of the patient's hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start16 Jan 2017
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Roue, Professor, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885051
- Sponsor's protocol ID
- TRIPAIN RB 16.002
- Acronym
- TRIPAIN
- Status last verified
- Oct 2020
- First submitted
- 26 Aug 2016
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Gendras J, Lavenant P, Sicard-Cras I, Consigny M, Misery L, Anand KJS, Sizun J, Roue JM. The newborn infant parasympathetic evaluation index for acute procedural pain assessment in preterm infants. Pediatr Res. 2021 May;89(7):1840-1847. doi: 10.1038/s41390-020-01152-4. Epub 2020 Sep 22.
PubMed 32961546
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn
- ClinicalTrials.gov ID
- NCT02885051
- Acronym / sponsor ID
- TRIPAIN / TRIPAIN RB 16.002
- Conditions
- Pain, Preterm Newborn
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preterm newborn | Experimental | Procedure: Recording of skin conductance and heart rate variability.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. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of skin conductance and heart rate variability.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. | Procedure or surgery | preterm newborn |
Primary outcome
Correlation between HFVI index and PIPP-R pain score .
Time frame: 12 months plus the total duration of the patient's hospitalization
In case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation.
5 secondary outcomes
Correlation between skin conductance and pain score PIPP-R.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months plus the total duration of the patient's hospitalization
Caregiver satisfaction with each technique via the likert scale.
Time frame: 12 months plus the total duration of the patient's hospitalization
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Results publication: PubMed 32961546Gendras J, Lavenant P, Sicard-Cras I, Consigny M, Misery L, Anand KJS, Sizun J, Roue JM. The newborn infant parasympathetic evaluation index for acute procedural pain assessment in preterm infants. Pediatr Res. 2021 May;89(7):1840-1847. doi: 10.1038/s41390-020-01152-4. Epub 2020 Sep 22.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Roue, Professor principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recording of skin conductance and heart rate variability. in people with Pain and Preterm Newborn, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between HFVI index and PIPP-R pain score . (time frame: 12 months plus the total duration of the patient's hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02885051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.