Evaluation of Pain in Preterm Newborn

Not Applicable

Terminated

• Conditions: Preterm Newborn; Pain
• Interventions: Procedure: Recording of skin conductance and heart rate variability.

• Registration Number: NCT02885051
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Study Start: 2017-01-16
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
preterm newborn	Recording of skin conductance and heart rate variability.	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.

Primary Outcome Measures

Name	Time	Method
Correlation between HFVI index and PIPP-R pain score .	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

Name	Time	Method
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	This correlation will be measured
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	This correlation will be measured
Correlation between skin conductance and pain score PIPP-R.	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.
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	This correlation will be measured
Caregiver satisfaction with each technique via the likert scale.	12 months plus the total duration of the patient's hospitalization	The score will be measured

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France