Clincosm LogoSign in Get a demo

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

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT05223790
Collaborator
(none)
50
Enrollment
1
Location
23.3
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Pain measurement during care procedures in neonatal reanimation

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
Actual Study Start Date :
Mar 22, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Days to 7 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hop Jeanne de Flandre Chu Lille Lille France 59037

Sponsors and Collaborators

  • University Hospital, Lille

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT05223790
Other Study ID Numbers:
  • 2021_0238
First Posted:
Feb 4, 2022
Last Update Posted:
Apr 19, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Lille
NIPE
Newborn Infant Parasympathetic Evaluation
Pain measurement
Neonatal care
Additional relevant MeSH terms:
Premature Birth

Study Results

No Results Posted as of Apr 19, 2022