Evaluation of Pain in Preterm Newborn

Pain Clinical Trial

— TRIPAIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02885051
• Other study ID #: TRIPAIN RB 16.002
• Status: Terminated
• Phase: N/A
• Start date: January 16, 2017
• Est. completion date: January 24, 2018

Study information

• Verified date: October 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Months

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Premature Birth
• Preterm Newborn

Intervention

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.

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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