NCT02885051

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 16, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2018

Completed
Last Updated

December 12, 2025

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

August 26, 2016

Last Update Submit

December 5, 2025

Conditions

PainPreterm Newborn

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Correlation between skin conductance and pain score PIPP-R.

    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

    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

    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

    12 months plus the total duration of the patient's hospitalization

  • Caregiver satisfaction with each technique via the likert scale.

    12 months plus the total duration of the patient's hospitalization

Study Arms (1)

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.

Procedure: Recording of skin conductance and heart rate variability.

Interventions

Recording of skin conductance and heart rate variability.PROCEDURE

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.

preterm newborn

Eligibility Criteria

AgeUp to 2 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brest

Brest, 29609, France

Location

Related Publications (1)

  • 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.

    PMID: 32961546RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Michel Roue, Professor

    CHRU de Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

January 16, 2017

Primary Completion

January 24, 2018

Study Completion

January 24, 2018

Last Updated

December 12, 2025

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
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.

Locations

FR(1)