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Evaluation of Pain in Preterm Newborn (TRIPAIN)

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ClinicalTrials.gov Identifier: NCT02885051
Recruitment Status : Terminated (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.)
First Posted : August 31, 2016
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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).

Condition or disease Intervention/treatment Phase
Pain Preterm Newborn Procedure: Recording of skin conductance and heart rate variability. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : January 24, 2018

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Correlation between skin conductance and pain score PIPP-R. [ 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.

  2. 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 ]
    This correlation will be measured

  3. 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 ]
    This correlation will be measured

  4. 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 ]
    This correlation will be measured

  5. Caregiver satisfaction with each technique via the likert scale. [ Time Frame: 12 months plus the total duration of the patient's hospitalization ]
    The score will be measured



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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885051


Locations
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France
CHRU Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Jean-Michel Roue, Professor CHRU de Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02885051    
Other Study ID Numbers: TRIPAIN RB 16.002
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications