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

April 29, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 1 week (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of the NIPE measures between before and during care.
Time Frame: 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.
From 10 minutes before the care to 10 minutes after the beginning of the care

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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
From 10 minutes before the care to 10 minutes after the care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Riadh Boukris, MD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2022

Primary Completion (Actual)

January 13, 2025

Study Completion (Actual)

January 13, 2025

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021_0238

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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