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

Recruiting

• Conditions: Pain Measurement; Reanimation; Neonatal

• Registration Number: NCT05223790
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-04
• Study Start: 2022-03-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-03
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation of the NIPE measures between before and during care.	From 10 minutes before the care to 10 minutes after the beginning of the care	Average of NIPE mesures 10 minutes before the begining of the care and 10 minutes after.

Secondary Outcome Measures

Name	Time	Method
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	Study 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
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	The average of NIPE mesures 10 minutes before care, 10 minutes after the begining and 10 minutes after the end of the care were collected. And the same for the PIPP-R behavioral scale mesures.
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 lowest NIPE mesures during the 10 minutes before care, 10 minutes after the begining and 10 minutes after the end of the care were collected. And the same for the PIPP-R behavioral scale mesures.

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France