Evaluation of Pain in Preterm Newborn (TRIPAIN)

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).

Study Overview

• Status: Terminated
• Conditions: Pain; Preterm Newborn
• Intervention / Treatment: Procedure: Recording of skin conductance and 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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU BREST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: preterm newborn; 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months plus the total duration of the patient's hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	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	12 months plus the total duration of the patient's hospitalization

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Jean-Michel Roue, Professor, CHRU de Brest

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2017
• Primary Completion (Actual): January 24, 2018
• Study Completion (Actual): January 24, 2018

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimated): August 31, 2016

Study Record Updates

• Last Update Posted (Estimated): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: TRIPAIN RB 16.002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No