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Evaluation of Pain in Preterm Newborn

Comparative Analysis of a Behavioral Level, Skin Conductance and Heart Rate Variability in Assessing the Pain in Preterm Newborn

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02885051
Acronym
TRIPAIN
Enrollment
91
Registered
2016-08-31
Start date
2017-01-16
Completion date
2018-01-24
Last updated
2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Preterm Newborn

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.

Interventions

PROCEDURERecording 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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between HFVI index and PIPP-R pain score .12 months plus the total duration of the patient's hospitalizationIn case of repeated measurements on the same child, only the first couple of steps will be considered for this correlation calculation.

Secondary

MeasureTime frameDescription
Correlation between skin conductance and pain score PIPP-R.12 months plus the total duration of the patient's hospitalizationIn 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 not12 months plus the total duration of the patient's hospitalizationThis correlation will be measured
Correlation of cutaneous conductance, HFVI and PIPP-R according to the gestational age group type12 months plus the total duration of the patient's hospitalizationThis correlation will be measured
Correlation of cutaneous conductance, HFVI and PIPP-R according to the sex of the child12 months plus the total duration of the patient's hospitalizationThis correlation will be measured
Caregiver satisfaction with each technique via the likert scale.12 months plus the total duration of the patient's hospitalizationThe score will be measured

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026