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Completed

NCT Number: NCT05223790

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

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.

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Key information

Conditions

Neonatal Pain Measurement Reanimation

Age range

0 day–7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain measurement during care procedures in neonatal reanimation

Device

Pain measurement during care procedures in neonatal reanimation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  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

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: NIPEpréma

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2022
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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