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

Pain Measurement Clinical Trial

— NIPEpréma  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05223790
• Other study ID #: 2021_0238
• Status: Recruiting
• Start date: March 22, 2022
• Est. completion date: November 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Lille
• Contact: Riadh Boukhris, MD
• Phone: 0320445962
• Email: riadh.boukhris[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Neonatal
• Pain Measurement

Intervention

Device:
• Pain measurement during care procedures in neonatal reanimation
Pain measurement during care procedures in neonatal reanimation

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period	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.	From 10 minutes after the beginning of the care to 10 minutes after the end of the care
Secondary	Correlation between the NIPEmin and the PIPP-R behavioural scale for each period	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.	From 10 minutes before the care to 10 minutes after the care
Secondary	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	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	From 10 minutes before the care to 10 minutes after the care