Evaluation of Pain in Preterm Newborn (TRIPAIN)

Regional University Hospital Center (CHRU)

Status: Terminated

Conditions: Preterm Newborn; Pain

Treatments: Procedure: Recording of skin conductance and heart rate variability.

Study type: Interventional

Funder types: Other

Identifiers

NCT02885051

TRIPAIN RB 16.002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 91 patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

preterm newborn

Experimental group

Description:

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.

Treatment:

Procedure: Recording of skin conductance and heart rate variability.