Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.

NCT05223790 | Completed

• 1 other identifier: 2021_0238
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component). So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.

Conditions

Neonatal; Pain Measurement; Reanimation

Keywords

NIPE; Newborn Infant Parasympathetic Evaluation; Pain measurement; Neonatal care

Outcome Measures

Primary Outcomes (1)

• Variation of the NIPE measures between before and during care.

  Average of NIPE mesures 10 minutes before the begining of the care and 10 minutes after.

  From 10 minutes before the care to 10 minutes after the beginning of the care

Secondary Outcomes (3)

• Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period

  From 10 minutes after the beginning of the care to 10 minutes after the end of the care

• Correlation between the NIPEmin and the PIPP-R behavioural scale for each period

  From 10 minutes before the care to 10 minutes after the care

• The discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale

  From 10 minutes before the care to 10 minutes after the care

Interventions

Pain measurement during care procedures in neonatal reanimation DEVICE

Pain measurement during care procedures in neonatal reanimation

Eligibility Criteria

• Age: 0 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infant born very premature and aged less than 8 days ventilated and sedated in neonatal reanimation

You may qualify if:

• Infant born very premature before 34 weeks of amenorrhoea + 0 day
• Age ≤ 7 days
• Admitted in neonatal reanimation
• Sedated, intubated, ventilated

You may not qualify if:

• High frequency oscillation ventilation
• Heart rate non sinusal
• Inotropes and atropine
• Opposition from the guardian of parental authority
• Difficulty of comprehension or communication making the parental information impossible

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

Study Officials

• Riadh Boukris, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: February 4, 2022
• Study Start: April 21, 2022
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)